SepsisNCT07436130
Curcumin in Critically Ill Patients With Sepsis
A study testing Curcumin in people with Sepsis, run by Hospital Civil de Guadalajara at 1 site in Mexico.
Trial summary
Sepsis is a life-threatening condition that occurs when the body's response to an infection becomes overwhelming and damages its own organs. It is one of the leading causes of death in critically ill (very sick) patients worldwide. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis
- What is being tested?
- Curcumin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteMexico
- Study dates
- 1 Mar 2026to 31 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients older than 18 years of either sex.
- Critically ill patients with a diagnosis of sepsis admitted to the Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde."
- Patients receiving enteral nutrition.
- Written informed consent signed by the patient or their legally authorized representative.
Who cannot join
- Patients with a history of allergy or hypersensitivity to curcumin.
- Patients with autoimmune diseases or severe immunosuppression.
- Patients in a terminal condition with a life expectancy of less than 48 hours.
- Patients with intolerance to enteral feeding, intestinal ischemia, intestinal obstruction, pancreatitis or short bowel syndrome.
- Patients with acute liver failure or decompensated liver cirrhosis.
- Patients with clinically significant active bleeding (e.g., gastrointestinal bleeding, intracranial hemorrhage, etc.).
Show all 9Show fewer
- Patients requiring therapeutic anticoagulation (warfarin, direct oral anticoagulants [DOACs], or full-dose heparin).
- Patients receiving exclusively parenteral nutrition.
- Pregnant or breastfeeding women.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mexico1 site, 1 recruiting
- Recruiting
Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde"
Guadalajara, Jalisco, 44280
Kevin S Herrmann-Villatoro, Doctor of Medicine (MD), +52 322 120 9720, kherrmannv99@gmail.com
Kevin S Herrmann-Villatoro, Doctor of Medicine (MD)
About this study
Official title: Immunomodulatory Effect of Curcumin in Critically Ill Patients With Sepsis at the Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde": A Randomized, Double-Blind, Placebo-Controlled Clinical Trial
Sepsis is a life-threatening condition that occurs when the body's response to an infection becomes overwhelming and damages its own organs. It is one of the leading causes of death in critically ill (very sick) patients worldwide. Despite advances in antibiotics, intensive care, and life-support technologies, sepsis remains difficult to treat because much of the harm comes not only from the infection itself, but from an exaggerated and uncontrolled inflammatory response in the body. When a person develops sepsis, the immune system releases large amounts of inflammatory substances meant to fight infection. However, in many cases this response becomes excessive, leading to organ failure, prolonged stays in the intensive care unit (ICU), and increased risk of death. Current treatments focus mainly on controlling the infection and supporting failing organs, but there are limited therapies that directly help regulate this harmful immune overreaction. Curcumin is a natural compound found in turmeric, a spice commonly used in food. In laboratory studies and some clinical research, curcumin has shown anti-inflammatory and antioxidant properties. It appears to influence several pathways in the immune system that are involved in the inflammatory process. However, its potential benefits in patients with severe infections such as sepsis have not been fully studied in a rigorous clinical setting. The purpose of this clinical trial is to evaluate whether curcumin, when added to standard medical treatment, can help modulate (regulate) the immune response in critically ill patients with sepsis. This study will be conducted as a randomized, double-blind, placebo-controlled clinical trial at the Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde" in Guadalajara, Mexico. "Randomized" means that participants will be assigned by chance to receive either curcumin or a placebo (a look-alike substance that contains no drug). "Double-blind" means that neither the patients nor the healthcare team will know who is receiving curcumin and who is receiving the placebo during the study. This design helps ensure that the results are objective and scientifically reliable. Participants in the study will continue to receive all standard treatments for sepsis, including antibiotics and intensive care support. The study will measure inflammatory markers in the blood, organ function, and important clinical outcomes such as the need for organ support and length of stay in the ICU. Safety will also be carefully monitored.
Hypothesis:
The investigators hypothesize that in critically ill patients with sepsis, the addition of curcumin to standard treatment will help regulate the excessive inflammatory response, leading to improved biological markers of inflammation and potentially better clinical outcomes, compared to standard treatment alone. If curcumin proves to be beneficial and safe in this population, it could represent an accessible and relatively low-cost complementary therapy to improve the management of sepsis. However, this study is necessary to determine scientifically whether these potential benefits are real and clinically meaningful. The ultimate goal of this research is to contribute new evidence that may improve the care and survival of patients suffering from one of the most severe and challenging conditions treated in intensive care medicine.
Read the detailed description
Sepsis is a complex, dysregulated host response to infection characterized by systemic inflammation, immune dysfunction, endothelial injury, oxidative stress, microcirculatory alterations, and subsequent organ dysfunction. Despite adherence to guideline-directed management, including early antimicrobial therapy, hemodynamic optimization, and organ support, sepsis continues to be associated with high morbidity and mortality. Increasing evidence suggests that both hyperinflammatory and subsequent immunosuppressive phases contribute to adverse outcomes, highlighting the need for adjunctive immunomodulatory therapies. Curcumin is a bioactive polyphenol derived from Curcuma longa, and has demonstrated anti-inflammatory, antioxidant, and immunomodulatory properties in preclinical models. Curcumin has been shown to modulate multiple intracellular signaling pathways implicated in sepsis pathophysiology, including inhibition of NF-κB activation, downregulation of pro-inflammatory cytokines (e.g., TNF-α, IL-1β, IL-6), attenuation of oxidative stress via Nrf2 activation, and modulation of Toll-like receptor signaling. Additionally, curcumin may influence endothelial function, mitochondrial homeostasis, and apoptosis pathways. However, clinical data in critically ill septic patients remain limited, and robust randomized controlled trials are lacking. This study is designed as a prospective, randomized, double-blind, placebo-controlled clinical trial conducted in critically ill adult patients diagnosed with sepsis and admitted at the Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde" in Guadalajara, Mexico. The primary objective is to evaluate whether adjunctive administration of a bioavailable formulation of curcumin, in addition to standard sepsis management, favorably modulates systemic inflammation and organ dysfunction. Participants will be randomly assigned in a 1:1 ratio to receive either curcumin or a matched placebo. Randomization will be performed using a computer-generated sequence with allocation concealment through sequentially numbered, opaque, sealed containers prepared by personnel not involved in patient care or outcome assessment. Blinding will be maintained for participants, treating clinicians, investigators, laboratory personnel, and data analysts. The investigational product and placebo will be identical in appearance, packaging, and administration schedule. All participants will receive standard-of-care management for sepsis according to institutional protocols aligned with international guidelines, including antimicrobial therapy, fluid resuscitation, vasopressor support, ventilatory support, renal replacement therapy, and other organ-support measures as clinically indicated. The intervention consists of adjunctive administration of a standardized, enhanced-bioavailability formulation of curcumin delivered enterally. The dosing regimen, duration of administration, and formulation characteristics are predefined in the protocol and selected based on prior safety data and pharmacokinetic considerations. Enteral administration will occur via oral route or feeding tube in patients receiving enteral nutrition. Treatment will begin within a defined time window after fulfillment of sepsis diagnostic criteria and admission. Adherence to the intervention will be documented daily. Curcumin is known to have limited bioavailability due to poor absorption, rapid metabolism, and systemic elimination. Therefore, the selected formulation incorporates strategies to enhance systemic exposure. The dosing schedule is designed to maintain sustained plasma concentrations within ranges associated with biological activity in prior human studies, while remaining within established safety parameters. Clinical and laboratory data will be collected at baseline and at prespecified time points during their stay. Data will include demographic information, comorbidities, infection source, hemodynamic parameters, organ support requirements, and relevant biochemical markers. Inflammatory and immunologic biomarkers will be measured using validated laboratory techniques. Blood samples will be processed according to standardized protocols to ensure reproducibility and minimize pre-analytical variability. Adverse events will be recorded and categorized according to severity and relatedness to the investigational product. Particular attention will be given to gastrointestinal intolerance, hepatotoxicity, bleeding risk, and allergic reactions. Routine laboratory monitoring will include liver function tests and coagulation parameters to ensure safety. Criteria for discontinuation of the intervention include predefined safety thresholds or clinical judgment by the treating team. Sample size calculation is based on detecting a clinically meaningful difference in predefined biological or clinical parameters between groups, with an appropriate power and two-sided alpha level. The calculation incorporates estimated variance derived from prior studies in similar populations. Statistical analysis will follow the intention-to-treat principle. Continuous variables will be assessed for normality and analyzed using parametric or non-parametric tests as appropriate. Categorical variables will be compared using chi-square or Fisher's exact test. Multivariable analyses will be performed to adjust for potential confounders such as baseline severity of illness, comorbid conditions, and infection source. The study protocol has been submitted to and approved by the institutional Research Ethics Committee. Written informed consent will be obtained from patients or legally authorized representatives prior to enrollment, in accordance with national (Mexican) regulations and the Declaration of Helsinki. Given the critical illness context, provisions are included for surrogate consent when patients lack decision-making capacity. Participants retain the right to withdraw at any time without affecting their standard medical care. Curcumin has an established safety profile in prior human studies at comparable doses, and the risk associated with participation is considered minimal beyond standard treatment. The potential benefit includes improved regulation of systemic inflammation and organ function. This study addresses an important gap in sepsis research by evaluating a multi-target immunomodulatory compound within a rigorous randomized controlled framework. Unlike single-pathway biologic agents that have historically failed in sepsis trials, curcumin exerts pleiotropic effects across inflammatory, oxidative, and endothelial pathways, which may be advantageous in a syndrome characterized by complex immune dysregulation. If adjunctive curcumin therapy demonstrates biological and clinical benefit without increased adverse events, it may represent a cost-effective and accessible strategy for resource-limited settings. Furthermore, this study may provide mechanistic insights into host-response modulation in sepsis and inform future translational research.
- Conditions
- Sepsis
- Being tested
- Curcumin, Placebo
- Keywords
- Sepsis, Curcumin, Critical Illness, Immunomodulation
- Medical subject headings
- Sepsis, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CurcuminDietary supplement
Also called Curcuminoid, Diferuloylmethane, 1,7-bis(4-hydroxy-3-methoxyphenyl)-1,6-heptadiene-3,5-dione, Curcumin I
The investigational product consists of an oral, enhanced-bioavailability formulation of curcumin (Longvida®). Each capsule contains 500 mg of formulation standardized to 20% curcumin, providing 100 mg of active curcumin per capsule. Participants assigned to the experimental arm will receive 2 capsules three times daily (every 8 hours) for 10 consecutive days, for a total of 6 capsules per day and 600 mg of curcumin daily.
PlaceboDrug
Participants randomized to this arm will receive standard-of-care treatment for sepsis plus a matched placebo administered enterally. The placebo consists of starch-based capsules identical in appearance to the active product. Patients will take 2 placebo capsules three times daily for 10 days (total 6 capsules/day), following the same schedule as the experimental arm, while all other treatment remains at the discretion of the treating team.
| Study group | Role | What they receive |
|---|---|---|
| Curcumin + Standard of Care | Experimental | Participants in this arm will receive standard-of-care treatment for sepsis plus adjunctive curcumin administered enterally. Each patient will receive 2 capsules of curcumin (enhanced-bioavailability curcumin formulation containing 20% curcumin), 500 mg per capsule (100 mg of curcumin per capsule), three times daily for 10 days. This corresponds to a total of 6 capsules per day, providing 600 mg of curcumin daily. Treatment will begin within the predefined enrollment window after diagnosis. All other treatment, including antimicrobials and organ support, will remain at the discretion of the treating team. Receives: Dietary Supplement: Curcumin |
| Placebo + Standard of Care | Placebo comparator | Participants in this arm will receive standard-of-care treatment for sepsis plus a matched placebo administered enterally. Patients will take 2 starch-based capsules three times daily for 10 days (total of 6 capsules per day), following the same schedule as the experimental arm. The placebo capsules are identical in appearance and packaging to the active product to maintain blinding. All other tratment, including antimicrobials and organ support, will remain at the discretion of the treating team. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Interleukin-6 (IL-6) from baseline to Day 10 of treatment.
Serum concentrations of the pro-inflammatory cytokine interleukin-6 (IL-6, pg/mL) will be measured in peripheral venous blood samples collected at baseline (prior to initiation of the intervention) and on Day 10 of treatment. Samples will be processed under standardized laboratory conditions and analyzed using validated quantitative immunoassay techniques (enzyme-linked immunosorbent assay [ELISA]). Results will be reported in pg/mL. The primary endpoint will be defined as the change in cytokine levels from baseline to Day 10, comparing the curcumin and placebo groups. A greater reduction in circulating cytokine concentrations will be interpreted as evidence of a modulatory effect on the systemic inflammatory response associated with sepsis.
Measured: Baseline to Day 10
Change in Interleukin-1 beta (IL-1β) from baseline to Day 10 of treatment.
Serum concentrations of the pro-inflammatory cytokine interleukin-1 beta (IL-1β, pg/mL), will be measured in peripheral venous blood samples collected at baseline (prior to initiation of the intervention) and on Day 10 of treatment. Samples will be processed under standardized laboratory conditions and analyzed using validated quantitative immunoassay techniques (enzyme-linked immunosorbent assay [ELISA]). Results will be reported in pg/mL. The primary endpoint will be defined as the change in cytokine levels from baseline to Day 10, comparing the curcumin and placebo groups. A greater reduction in circulating cytokine concentrations will be interpreted as evidence of a modulatory effect on the systemic inflammatory response associated with sepsis.
Measured: Baseline to Day 10
Change in tumor necrosis factor-alpha (TNF-α) from baseline to Day 10 of treatment.
Serum concentrations of the pro-inflammatory cytokine tumor necrosis factor-alpha (TNF-α, pg/mL) will be measured in peripheral venous blood samples collected at baseline (prior to initiation of the intervention) and on Day 10 of treatment. Samples will be processed under standardized laboratory conditions and analyzed using validated quantitative immunoassay techniques (enzyme-linked immunosorbent assay [ELISA]). Results will be reported in pg/mL. The primary endpoint will be defined as the change in cytokine levels from baseline to Day 10, comparing the curcumin and placebo groups. A greater reduction in circulating cytokine concentrations will be interpreted as evidence of a modulatory effect on the systemic inflammatory response associated with sepsis.
Measured: Baseline to Day 10
Secondary outcomes (12)
Change in high-sensitivity C-reactive protein (hs-CRP) from baseline to Day 10 of treatment.
Serum levels of high-sensitivity C-reactive protein (hs-CRP, mg/L) will be measured at baseline (prior to initiation of the intervention) and on Day 10 of treatment. hs-CRP will be quantified using standardized automated immunoassays. Results will be reported in mg/L.
The secondary endpoint will be defined as the change in hs-CRP from baseline to Day 10, comparing the curcumin and placebo groups. A greater reduction in hs-CRP will be interpreted as evidence of attenuation of systemic inflammation.
Measured: Baseline to Day 10
Change in procalcitonin (PCT) from baseline to Day 10 of treatment.
Serum levels of procalcitonin (PCT, ng/mL) will be measured at baseline (prior to initiation of the intervention) and on Day 10 of treatment. PCT will be quantified using standardized automated immunoassays. Results will be reported in ng/mL. The secondary endpoint will be defined as the change in PCT from baseline to Day 10, comparing the curcumin and placebo groups. A greater reduction in PCT will be interpreted as evidence of attenuation of systemic inflammation.
Measured: Baseline to Day 10
Change in erythrocyte sedimentation rate (ESR) from baseline to Day 10 of treatment.
Serum levels of erythrocyte sedimentation rate (ESR, ng/mL), will be measured at baseline (prior to initiation of the intervention) and on Day 10 of treatment. ESR will be determined using conventional laboratory methodology (Westergren method). Results will be reported in ng/mL. The secondary endpoint will be defined as the change in ESR from baseline to Day 10, comparing the curcumin and placebo groups. A greater reduction in ESR will be interpreted as evidence of attenuation of systemic inflammation.
Measured: Baseline to Day 10
Days of Hospital Length of Stay and Days of ICU Length of Stay
Clinical evolution will be evaluated by measuring total hospital length of stay, defined as the number of days from hospital admission to discharge, and ICU length of stay, defined as the number of days from ICU admission to ICU discharge, both reported in days. These outcomes will be compared between the curcumin and placebo groups to determine differences in clinical recovery.
Measured: From date of enrollment until the date of hospital discharge; assesed up to 52 weeks
Days of Mechanical Ventilation
Among patients who require mechanical ventilation, the duration of ventilatory support will be measured as the total number of days receiving invasive mechanical ventilation. This outcome will be compared between the curcumin and placebo groups to determine differences in clinical recovery.
Measured: From date of intubation until the date of extubation; assesed up to 52 weeks
Number of Deaths (Mortality)
All-cause mortality will be assessed as the proportion of patients who die during hospitalization, expressed as a percentage. This outcome will be compared between the curcumin and placebo groups to determine differences in clinical recovery and overall prognosis.
Measured: From date of enrollment until death; assesed up to 52 weeks
Change in "Sequential Organ Failure Assessment" (SOFA) score from baseline to Day 10 of treatment.
Clinical severity will be evaluated using the Sequential Organ Failure Assessment (SOFA) score. It will be calculated according to its validated criteria and reported as total score (0-24 points), higher scores mean a worse outcome. Comparisons between the curcumin and placebo groups will evaluate differences in SOFA score at baseline and Day 10.
Measured: Baseline and Day 10
Change in "Sequential Organ Failure Assessment 2" (SOFA-2) score from baseline to Day 10 of treatment.
Clinical severity will be evaluated using the Sequential Organ Failure Assessment 2 (SOFA-2) score. It will be calculated according to its validated criteria and reported as total score (0-24 points), higher scores mean a worse outcome. Comparisons between the curcumin and placebo groups will evaluate differences in SOFA-2 score at baseline and Day 10.
Measured: Baseline and Day 10
Change in "Acute Physiology and Chronic Health Evaluation IV" (APACHE IV) score from baseline to Day 10 of treatment
Clinical severity will be evaluated using the Acute Physiology and Chronic Health Evaluation IV (APACHE IV) score. It will be calculated according to its validated criteria and reported as total score (0-286 points), higher scores mean a worse outcome. Comparisons between the curcumin and placebo groups will evaluate differences in APACHE IV score at baseline and Day 10.
Measured: Baseline and Day 10
Change in PaO2/FiO2 ratio from baseline to Day 10 of treatment.
Oxygenation status will be assessed using the PaO2/FiO2 ratio, calculated from arterial blood gas analysis and corresponding fraction of inspired oxygen. Results will be reported as unitless ratio, lower ratios mean a worse outcome. Comparisons between the curcumin and placebo groups will evaluate differences in PaO2/FiO2 ratio at baseline and Day 10.
Measured: Baseline and Day 10
Change in neutrophil-to-lymphocyte ratio (NLR) and platelet-to-lymphocyte ratio (PLR) from baseline to Day 10 of treatment.
Inflammatory status will be evaluated using the neutrophil-to-lymphocyte ratio (NLR) and platelet-to-lymphocyte ratio (PLR). These will be derived from complete blood count parameters. The results will be expressed as unitless ratios, higher ratios mean a worse outcome. Comparisons between the curcumin and placebo groups will evaluate differences in inflammatory indices at baseline and Day 10.
Measured: Baseline and Day 10
Number of participants with adverse events
Safety and tolerability will be assessed by monitoring the incidence, type, and severity of adverse events occurring from the first dose of study medication through Day 10 and up to hospital discharge. Adverse events will be recorded and classified according to clinical severity (mild, moderate, severe) and relationship to the investigational product (unrelated, possibly related, probably related). Serious adverse events will be defined according to standard regulatory criteria, including events resulting in death, life-threatening conditions, prolonged hospitalization, significant disability, or other medically important events. Results will be reported as the total number of adverse events.
Measured: From date of first dose until the date of hospital discharge; assesed up to 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start1 Mar 2026
- Primary completion31 Mar 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (79)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is designed as a prospective, randomized, parallel-group interventional clinical trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Civil de Guadalajara
- Sponsor type
- University, hospital or other
- Collaborators
- University of Guadalajara
- Responsible party
- Principal investigator, Kevin Herrmann Villatoro, Hospital Civil de Guadalajara
- Investigators
- Enrique Cervantes-Perez, MD and MSc, Study director, Hospital Civil de GuadalajaraMariana Chávez-Tostado, BS Nutrition, MSc and PhD, Study director, University of Guadalajara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07436130
- Sponsor's protocol ID
- CEI 026/26
- Status last verified
- Sep 2026
- First submitted
- 17 Feb 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the results reported in publications arising from this study will be shared. This includes demographic variables, baseline clinical characteristics, laboratory measurements (including cytokine levels and inflammatory markers), severity scores, clinical outcomes, and safety data necessary to reproduce the primary and secondary analyses. All shared data will be fully anonymized to protect participant confidentiality and will exclude any direct identifiers.
Publications
Panknin TM, Howe CL, Hauer M, Bucchireddigari B, Rossi AM, Funk JL. Curcumin Supplementation and Human Disease: A Scoping Review of Clinical Trials. Int J Mol Sci. 2023 Feb 24;24(5):4476. doi: 10.3390/ijms24054476.
PubMed 36901908Gupte PA, Giramkar SA, Harke SM, Kulkarni SK, Deshmukh AP, Hingorani LL, Mahajan MP, Bhalerao SS. Evaluation of the efficacy and safety of Capsule Longvida(R) Optimized Curcumin (solid lipid curcumin particles) in knee osteoarthritis: a pilot clinical study. J Inflamm Res. 2019 Jun 5;12:145-152. doi: 10.2147/JIR.S205390. eCollection 2019.
PubMed 31239749Feng J, Li Z, Tian L, Mu P, Hu Y, Xiong F, Ma X. Efficacy and safety of curcuminoids alone in alleviating pain and dysfunction for knee osteoarthritis: a systematic review and meta-analysis of randomized controlled trials. BMC Complement Med Ther. 2022 Oct 19;22(1):276. doi: 10.1186/s12906-022-03740-9.
PubMed 36261810Zhong W, Qian K, Xiong J, Ma K, Wang A, Zou Y. Curcumin alleviates lipopolysaccharide induced sepsis and liver failure by suppression of oxidative stress-related inflammation via PI3K/AKT and NF-kappaB related signaling. Biomed Pharmacother. 2016 Oct;83:302-313. doi: 10.1016/j.biopha.2016.06.036. Epub 2016 Jul 7.
PubMed 27393927Wang J, Wang H, Zhu R, Liu Q, Fei J, Wang S. Anti-inflammatory activity of curcumin-loaded solid lipid nanoparticles in IL-1beta transgenic mice subjected to the lipopolysaccharide-induced sepsis. Biomaterials. 2015;53:475-83. doi: 10.1016/j.biomaterials.2015.02.116. Epub 2015 Mar 20.
PubMed 25890744Zhu H, Wang X, Wang X, Liu B, Yuan Y, Zuo X. Curcumin attenuates inflammation and cell apoptosis through regulating NF-kappaB and JAK2/STAT3 signaling pathway against acute kidney injury. Cell Cycle. 2020 Aug;19(15):1941-1951. doi: 10.1080/15384101.2020.1784599. Epub 2020 Jul 2.
PubMed 32615888Yilmaz Savcun G, Ozkan E, Dulundu E, Topaloglu U, Sehirli AO, Tok OE, Ercan F, Sener G. Antioxidant and anti-inflammatory effects of curcumin against hepatorenal oxidative injury in an experimental sepsis model in rats. Ulus Travma Acil Cerrahi Derg. 2013 Nov;19(6):507-15. doi: 10.5505/tjtes.2013.76390.
PubMed 24347209Sathyabhama M, Priya Dharshini LC, Karthikeyan A, Kalaiselvi S, Min T. The Credible Role of Curcumin in Oxidative Stress-Mediated Mitochondrial Dysfunction in Mammals. Biomolecules. 2022 Oct 1;12(10):1405. doi: 10.3390/biom12101405.
PubMed 36291614Chen D, Wang H, Cai X. Curcumin interferes with sepsis-induced cardiomyocyte apoptosis via TLR1 inhibition. Rev Port Cardiol. 2023 Mar;42(3):209-221. doi: 10.1016/j.repc.2023.01.013. Epub 2023 Jan 23. English, Portuguese.
PubMed 36702348Yang C, Wu K, Li SH, You Q. Protective effect of curcumin against cardiac dysfunction in sepsis rats. Pharm Biol. 2013 Apr;51(4):482-7. doi: 10.3109/13880209.2012.742116. Epub 2013 Jan 22.
PubMed 23336318Yao Y, Luo R, Xiong S, Zhang C, Zhang Y. Protective effects of curcumin against rat intestinal inflammation-related motility disorders. Mol Med Rep. 2021 May;23(5):391. doi: 10.3892/mmr.2021.12030. Epub 2021 Mar 24.
PubMed 33760185Silva LS, Catalao CH, Felippotti TT, Oliveira-Pelegrin GR, Petenusci S, de Freitas LA, Rocha MJ. Curcumin suppresses inflammatory cytokines and heat shock protein 70 release and improves metabolic parameters during experimental sepsis. Pharm Biol. 2017 Dec;55(1):269-276. doi: 10.1080/13880209.2016.1260598.
PubMed 27927067Wang Y, Wang Y, Cai N, Xu T, He F. Anti-inflammatory effects of curcumin in acute lung injury: In vivo and in vitro experimental model studies. Int Immunopharmacol. 2021 Jul;96:107600. doi: 10.1016/j.intimp.2021.107600. Epub 2021 Mar 30.
PubMed 33798807Gong Z, Zhou J, Li H, Gao Y, Xu C, Zhao S, Chen Y, Cai W, Wu J. Curcumin suppresses NLRP3 inflammasome activation and protects against LPS-induced septic shock. Mol Nutr Food Res. 2015 Nov;59(11):2132-42. doi: 10.1002/mnfr.201500316. Epub 2015 Sep 2.
PubMed 26250869Tham CL, Lam KW, Rajajendram R, Cheah YK, Sulaiman MR, Lajis NH, Kim MK, Israf DA. The effects of a synthetic curcuminoid analogue, 2,6-bis-(4-hydroxyl-3-methoxybenzylidine)cyclohexanone on proinflammatory signaling pathways and CLP-induced lethal sepsis in mice. Eur J Pharmacol. 2011 Feb 10;652(1-3):136-44. doi: 10.1016/j.ejphar.2010.10.092. Epub 2010 Nov 30.
PubMed 21114991
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunomodulatory Effect of Curcumin in Critically Ill Patients With Sepsis at the Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde": A Randomized, Double-Blind, Placebo-Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07436130
- Acronym / sponsor ID
- CEI 026/26
- Conditions
- Sepsis
- Keywords
- Sepsis, Curcumin, Critical Illness, Immunomodulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Hospital Civil de GuadalajaraUniversity, hospital or other
- Collaborators
- University of Guadalajara
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Sepsis is a life-threatening condition that occurs when the body's response to an infection becomes overwhelming and damages its own organs. It is one of the leading causes of death in critically ill (very sick) patients worldwide. Despite advances in antibiotics, intensive care, and life-support technologies, sepsis remains difficult to treat because much of the harm comes not only from the infection itself, but from an exaggerated and uncontrolled inflammatory response in the body. When a person develops sepsis, the immune system releases large amounts of inflammatory substances meant to fight infection. However, in many cases this response becomes excessive, leading to organ failure, prolonged stays in the intensive care unit (ICU), and increased risk of death. Current treatments focus mainly on controlling the infection and supporting failing organs, but there are limited therapies that directly help regulate this harmful immune overreaction. Curcumin is a natural compound found in turmeric, a spice commonly used in food. In laboratory studies and some clinical research, curcumin has shown anti-inflammatory and antioxidant properties. It appears to influence several pathways in the immune system that are involved in the inflammatory process. However, its potential benefits in patients with severe infections such as sepsis have not been fully studied in a rigorous clinical setting. The purpose of this clinical trial is to evaluate whether curcumin, when added to standard medical treatment, can help modulate (regulate) the immune response in critically ill patients with sepsis. This study will be conducted as a randomized, double-blind, placebo-controlled clinical trial at the Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde" in Guadalajara, Mexico. "Randomized" means that participants will be assigned by chance to receive either curcumin or a placebo (a look-alike substance that contains no drug). "Double-blind" means that neither the patients nor the healthcare team will know who is receiving curcumin and who is receiving the placebo during the study. This design helps ensure that the results are objective and scientifically reliable. Participants in the study will continue to receive all standard treatments for sepsis, including antibiotics and intensive care support. The study will measure inflammatory markers in the blood, organ function, and important clinical outcomes such as the need for organ support and length of stay in the ICU. Safety will also be carefully monitored.
Hypothesis:
The investigators hypothesize that in critically ill patients with sepsis, the addition of curcumin to standard treatment will help regulate the excessive inflammatory response, leading to improved biological markers of inflammation and potentially better clinical outcomes, compared to standard treatment alone. If curcumin proves to be beneficial and safe in this population, it could represent an accessible and relatively low-cost complementary therapy to improve the management of sepsis. However, this study is necessary to determine scientifically whether these potential benefits are real and clinically meaningful. The ultimate goal of this research is to contribute new evidence that may improve the care and survival of patients suffering from one of the most severe and challenging conditions treated in intensive care medicine.
Detailed description
Sepsis is a complex, dysregulated host response to infection characterized by systemic inflammation, immune dysfunction, endothelial injury, oxidative stress, microcirculatory alterations, and subsequent organ dysfunction. Despite adherence to guideline-directed management, including early antimicrobial therapy, hemodynamic optimization, and organ support, sepsis continues to be associated with high morbidity and mortality. Increasing evidence suggests that both hyperinflammatory and subsequent immunosuppressive phases contribute to adverse outcomes, highlighting the need for adjunctive immunomodulatory therapies. Curcumin is a bioactive polyphenol derived from Curcuma longa, and has demonstrated anti-inflammatory, antioxidant, and immunomodulatory properties in preclinical models. Curcumin has been shown to modulate multiple intracellular signaling pathways implicated in sepsis pathophysiology, including inhibition of NF-κB activation, downregulation of pro-inflammatory cytokines (e.g., TNF-α, IL-1β, IL-6), attenuation of oxidative stress via Nrf2 activation, and modulation of Toll-like receptor signaling. Additionally, curcumin may influence endothelial function, mitochondrial homeostasis, and apoptosis pathways. However, clinical data in critically ill septic patients remain limited, and robust randomized controlled trials are lacking. This study is designed as a prospective, randomized, double-blind, placebo-controlled clinical trial conducted in critically ill adult patients diagnosed with sepsis and admitted at the Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde" in Guadalajara, Mexico. The primary objective is to evaluate whether adjunctive administration of a bioavailable formulation of curcumin, in addition to standard sepsis management, favorably modulates systemic inflammation and organ dysfunction. Participants will be randomly assigned in a 1:1 ratio to receive either curcumin or a matched placebo. Randomization will be performed using a computer-generated sequence with allocation concealment through sequentially numbered, opaque, sealed containers prepared by personnel not involved in patient care or outcome assessment. Blinding will be maintained for participants, treating clinicians, investigators, laboratory personnel, and data analysts. The investigational product and placebo will be identical in appearance, packaging, and administration schedule. All participants will receive standard-of-care management for sepsis according to institutional protocols aligned with international guidelines, including antimicrobial therapy, fluid resuscitation, vasopressor support, ventilatory support, renal replacement therapy, and other organ-support measures as clinically indicated. The intervention consists of adjunctive administration of a standardized, enhanced-bioavailability formulation of curcumin delivered enterally. The dosing regimen, duration of administration, and formulation characteristics are predefined in the protocol and selected based on prior safety data and pharmacokinetic considerations. Enteral administration will occur via oral route or feeding tube in patients receiving enteral nutrition. Treatment will begin within a defined time window after fulfillment of sepsis diagnostic criteria and admission. Adherence to the intervention will be documented daily. Curcumin is known to have limited bioavailability due to poor absorption, rapid metabolism, and systemic elimination. Therefore, the selected formulation incorporates strategies to enhance systemic exposure. The dosing schedule is designed to maintain sustained plasma concentrations within ranges associated with biological activity in prior human studies, while remaining within established safety parameters. Clinical and laboratory data will be collected at baseline and at prespecified time points during their stay. Data will include demographic information, comorbidities, infection source, hemodynamic parameters, organ support requirements, and relevant biochemical markers. Inflammatory and immunologic biomarkers will be measured using validated laboratory techniques. Blood samples will be processed according to standardized protocols to ensure reproducibility and minimize pre-analytical variability. Adverse events will be recorded and categorized according to severity and relatedness to the investigational product. Particular attention will be given to gastrointestinal intolerance, hepatotoxicity, bleeding risk, and allergic reactions. Routine laboratory monitoring will include liver function tests and coagulation parameters to ensure safety. Criteria for discontinuation of the intervention include predefined safety thresholds or clinical judgment by the treating team. Sample size calculation is based on detecting a clinically meaningful difference in predefined biological or clinical parameters between groups, with an appropriate power and two-sided alpha level. The calculation incorporates estimated variance derived from prior studies in similar populations. Statistical analysis will follow the intention-to-treat principle. Continuous variables will be assessed for normality and analyzed using parametric or non-parametric tests as appropriate. Categorical variables will be compared using chi-square or Fisher's exact test. Multivariable analyses will be performed to adjust for potential confounders such as baseline severity of illness, comorbid conditions, and infection source. The study protocol has been submitted to and approved by the institutional Research Ethics Committee. Written informed consent will be obtained from patients or legally authorized representatives prior to enrollment, in accordance with national (Mexican) regulations and the Declaration of Helsinki. Given the critical illness context, provisions are included for surrogate consent when patients lack decision-making capacity. Participants retain the right to withdraw at any time without affecting their standard medical care. Curcumin has an established safety profile in prior human studies at comparable doses, and the risk associated with participation is considered minimal beyond standard treatment. The potential benefit includes improved regulation of systemic inflammation and organ function. This study addresses an important gap in sepsis research by evaluating a multi-target immunomodulatory compound within a rigorous randomized controlled framework. Unlike single-pathway biologic agents that have historically failed in sepsis trials, curcumin exerts pleiotropic effects across inflammatory, oxidative, and endothelial pathways, which may be advantageous in a syndrome characterized by complex immune dysregulation. If adjunctive curcumin therapy demonstrates biological and clinical benefit without increased adverse events, it may represent a cost-effective and accessible strategy for resource-limited settings. Furthermore, this study may provide mechanistic insights into host-response modulation in sepsis and inform future translational research.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- This study is designed as a prospective, randomized, parallel-group interventional clinical trial
| Arm | Type | Receives |
|---|---|---|
| Curcumin + Standard of Care | Experimental | Dietary Supplement: CurcuminParticipants in this arm will receive standard-of-care treatment for sepsis plus adjunctive curcumin administered enterally. Each patient will receive 2 capsules of curcumin (enhanced-bioavailability curcumin formulation containing 20% curcumin), 500 mg per capsule (100 mg of curcumin per capsule), three times daily for 10 days. This corresponds to a total of 6 capsules per day, providing 600 mg of curcumin daily. Treatment will begin within the predefined enrollment window after diagnosis. All other treatment, including antimicrobials and organ support, will remain at the discretion of the treating team. |
| Placebo + Standard of Care | Placebo comparator | Drug: PlaceboParticipants in this arm will receive standard-of-care treatment for sepsis plus a matched placebo administered enterally. Patients will take 2 starch-based capsules three times daily for 10 days (total of 6 capsules per day), following the same schedule as the experimental arm. The placebo capsules are identical in appearance and packaging to the active product to maintain blinding. All other tratment, including antimicrobials and organ support, will remain at the discretion of the treating team. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients older than 18 years of either sex.
- Critically ill patients with a diagnosis of sepsis admitted to the Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde."
- Patients receiving enteral nutrition.
- Written informed consent signed by the patient or their legally authorized representative.
Key exclusion criteria (9 listed)
- Patients with a history of allergy or hypersensitivity to curcumin.
- Patients with autoimmune diseases or severe immunosuppression.
- Patients in a terminal condition with a life expectancy of less than 48 hours.
- Patients with intolerance to enteral feeding, intestinal ischemia, intestinal obstruction, pancreatitis or short bowel syndrome.
- Patients with acute liver failure or decompensated liver cirrhosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CurcuminAlso: Curcuminoid, Diferuloylmethane, 1,7-bis(4-hydroxy-3-methoxyphenyl)-1,6-heptadiene-3,5-dione, Curcumin IThe investigational product consists of an oral, enhanced-bioavailability formulation of curcumin (Longvida®). Each capsule contains 500 mg of formulation standardized to 20% curcumin, providing 100 mg of active curcumin per capsule. Participants assigned to the experimental arm will receive 2 capsules three times daily (every 8 hours) for 10 consecutive days, for a total of 6 capsules per day and 600 mg of curcumin daily. | Dietary supplement | Curcumin + Standard of Care |
| PlaceboParticipants randomized to this arm will receive standard-of-care treatment for sepsis plus a matched placebo administered enterally. The placebo consists of starch-based capsules identical in appearance to the active product. Patients will take 2 placebo capsules three times daily for 10 days (total 6 capsules/day), following the same schedule as the experimental arm, while all other treatment remains at the discretion of the treating team. | Drug | Placebo + Standard of Care |
Primary outcome
Change in Interleukin-6 (IL-6) from baseline to Day 10 of treatment.
Time frame: Baseline to Day 10
Serum concentrations of the pro-inflammatory cytokine interleukin-6 (IL-6, pg/mL) will be measured in peripheral venous blood samples collected at baseline (prior to initiation of the intervention) and on Day 10 of treatment. Samples will be processed under standardized laboratory conditions and analyzed using validated quantitative immunoassay techniques (enzyme-linked immunosorbent assay [ELISA]). Results will be reported in pg/mL. The primary endpoint will be defined as the change in cytokine levels from baseline to Day 10, comparing the curcumin and placebo groups. A greater reduction in circulating cytokine concentrations will be interpreted as evidence of a modulatory effect on the systemic inflammatory response associated with sepsis.
Change in Interleukin-1 beta (IL-1β) from baseline to Day 10 of treatment.
Time frame: Baseline to Day 10
Serum concentrations of the pro-inflammatory cytokine interleukin-1 beta (IL-1β, pg/mL), will be measured in peripheral venous blood samples collected at baseline (prior to initiation of the intervention) and on Day 10 of treatment. Samples will be processed under standardized laboratory conditions and analyzed using validated quantitative immunoassay techniques (enzyme-linked immunosorbent assay [ELISA]). Results will be reported in pg/mL. The primary endpoint will be defined as the change in cytokine levels from baseline to Day 10, comparing the curcumin and placebo groups. A greater reduction in circulating cytokine concentrations will be interpreted as evidence of a modulatory effect on the systemic inflammatory response associated with sepsis.
Change in tumor necrosis factor-alpha (TNF-α) from baseline to Day 10 of treatment.
Time frame: Baseline to Day 10
Serum concentrations of the pro-inflammatory cytokine tumor necrosis factor-alpha (TNF-α, pg/mL) will be measured in peripheral venous blood samples collected at baseline (prior to initiation of the intervention) and on Day 10 of treatment. Samples will be processed under standardized laboratory conditions and analyzed using validated quantitative immunoassay techniques (enzyme-linked immunosorbent assay [ELISA]). Results will be reported in pg/mL. The primary endpoint will be defined as the change in cytokine levels from baseline to Day 10, comparing the curcumin and placebo groups. A greater reduction in circulating cytokine concentrations will be interpreted as evidence of a modulatory effect on the systemic inflammatory response associated with sepsis.
12 secondary outcomes
Change in high-sensitivity C-reactive protein (hs-CRP) from baseline to Day 10 of treatment.
Time frame: Baseline to Day 10
Change in procalcitonin (PCT) from baseline to Day 10 of treatment.
Time frame: Baseline to Day 10
Change in erythrocyte sedimentation rate (ESR) from baseline to Day 10 of treatment.
Time frame: Baseline to Day 10
Days of Hospital Length of Stay and Days of ICU Length of Stay
Time frame: From date of enrollment until the date of hospital discharge; assesed up to 52 weeks
Days of Mechanical Ventilation
Time frame: From date of intubation until the date of extubation; assesed up to 52 weeks
Number of Deaths (Mortality)
Time frame: From date of enrollment until death; assesed up to 52 weeks
Change in "Sequential Organ Failure Assessment" (SOFA) score from baseline to Day 10 of treatment.
Time frame: Baseline and Day 10
Change in "Sequential Organ Failure Assessment 2" (SOFA-2) score from baseline to Day 10 of treatment.
Time frame: Baseline and Day 10
Change in "Acute Physiology and Chronic Health Evaluation IV" (APACHE IV) score from baseline to Day 10 of treatment
Time frame: Baseline and Day 10
Change in PaO2/FiO2 ratio from baseline to Day 10 of treatment.
Time frame: Baseline and Day 10
Change in neutrophil-to-lymphocyte ratio (NLR) and platelet-to-lymphocyte ratio (PLR) from baseline to Day 10 of treatment.
Time frame: Baseline and Day 10
Number of participants with adverse events
Time frame: From date of first dose until the date of hospital discharge; assesed up to 52 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Background: PubMed 36901908Panknin TM, Howe CL, Hauer M, Bucchireddigari B, Rossi AM, Funk JL. Curcumin Supplementation and Human Disease: A Scoping Review of Clinical Trials. Int J Mol Sci. 2023 Feb 24;24(5):4476. doi: 10.3390/ijms24054476.
- Background: PubMed 31239749Gupte PA, Giramkar SA, Harke SM, Kulkarni SK, Deshmukh AP, Hingorani LL, Mahajan MP, Bhalerao SS. Evaluation of the efficacy and safety of Capsule Longvida(R) Optimized Curcumin (solid lipid curcumin particles) in knee osteoarthritis: a pilot clinical study. J Inflamm Res. 2019 Jun 5;12:145-152. doi: 10.2147/JIR.S205390. eCollection 2019.
- Background: PubMed 36261810Feng J, Li Z, Tian L, Mu P, Hu Y, Xiong F, Ma X. Efficacy and safety of curcuminoids alone in alleviating pain and dysfunction for knee osteoarthritis: a systematic review and meta-analysis of randomized controlled trials. BMC Complement Med Ther. 2022 Oct 19;22(1):276. doi: 10.1186/s12906-022-03740-9.
- Background: PubMed 27393927Zhong W, Qian K, Xiong J, Ma K, Wang A, Zou Y. Curcumin alleviates lipopolysaccharide induced sepsis and liver failure by suppression of oxidative stress-related inflammation via PI3K/AKT and NF-kappaB related signaling. Biomed Pharmacother. 2016 Oct;83:302-313. doi: 10.1016/j.biopha.2016.06.036. Epub 2016 Jul 7.
- Background: PubMed 25890744Wang J, Wang H, Zhu R, Liu Q, Fei J, Wang S. Anti-inflammatory activity of curcumin-loaded solid lipid nanoparticles in IL-1beta transgenic mice subjected to the lipopolysaccharide-induced sepsis. Biomaterials. 2015;53:475-83. doi: 10.1016/j.biomaterials.2015.02.116. Epub 2015 Mar 20.
- Background: PubMed 32615888Zhu H, Wang X, Wang X, Liu B, Yuan Y, Zuo X. Curcumin attenuates inflammation and cell apoptosis through regulating NF-kappaB and JAK2/STAT3 signaling pathway against acute kidney injury. Cell Cycle. 2020 Aug;19(15):1941-1951. doi: 10.1080/15384101.2020.1784599. Epub 2020 Jul 2.
- Background: PubMed 24347209Yilmaz Savcun G, Ozkan E, Dulundu E, Topaloglu U, Sehirli AO, Tok OE, Ercan F, Sener G. Antioxidant and anti-inflammatory effects of curcumin against hepatorenal oxidative injury in an experimental sepsis model in rats. Ulus Travma Acil Cerrahi Derg. 2013 Nov;19(6):507-15. doi: 10.5505/tjtes.2013.76390.
- Background: PubMed 36291614Sathyabhama M, Priya Dharshini LC, Karthikeyan A, Kalaiselvi S, Min T. The Credible Role of Curcumin in Oxidative Stress-Mediated Mitochondrial Dysfunction in Mammals. Biomolecules. 2022 Oct 1;12(10):1405. doi: 10.3390/biom12101405.
- Background: PubMed 36702348Chen D, Wang H, Cai X. Curcumin interferes with sepsis-induced cardiomyocyte apoptosis via TLR1 inhibition. Rev Port Cardiol. 2023 Mar;42(3):209-221. doi: 10.1016/j.repc.2023.01.013. Epub 2023 Jan 23. English, Portuguese.
- Background: PubMed 23336318Yang C, Wu K, Li SH, You Q. Protective effect of curcumin against cardiac dysfunction in sepsis rats. Pharm Biol. 2013 Apr;51(4):482-7. doi: 10.3109/13880209.2012.742116. Epub 2013 Jan 22.
- Background: PubMed 33760185Yao Y, Luo R, Xiong S, Zhang C, Zhang Y. Protective effects of curcumin against rat intestinal inflammation-related motility disorders. Mol Med Rep. 2021 May;23(5):391. doi: 10.3892/mmr.2021.12030. Epub 2021 Mar 24.
- Background: PubMed 27927067Silva LS, Catalao CH, Felippotti TT, Oliveira-Pelegrin GR, Petenusci S, de Freitas LA, Rocha MJ. Curcumin suppresses inflammatory cytokines and heat shock protein 70 release and improves metabolic parameters during experimental sepsis. Pharm Biol. 2017 Dec;55(1):269-276. doi: 10.1080/13880209.2016.1260598.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the results reported in publications arising from this study will be shared. This includes demographic variables, baseline clinical characteristics, laboratory measurements (including cytokine levels and inflammatory markers), severity scores, clinical outcomes, and safety data necessary to reproduce the primary and secondary analyses. All shared data will be fully anonymized to protect participant confidentiality and will exclude any direct identifiers.
Related trials for Sepsis
Not yet recruitingObservational study
Serum GDF-15 and LGALS3BP as Prognostic Biomarkers in Sepsis
Sepsis, Septic Shock
RecruitingPhase 3
A Trial of Adjunctive Fludrocortisone (50mcg, 100mcg or Placebo) in Critically Ill Patients With Septic Shock Receiving Hydrocortisone, Evaluating Survival and Functional Recovery and the Influence of Transcriptomic Response
Septic Shock
RecruitingObservational study
Middle East Study of Infections in Patients With Hematological Malignancies
Hematological Malignancy, Hematopoetic Stem Cell Transplantation
RecruitingObservational study
Early Detection and Kinetics of Sepsis-Induced Coagulopathy in Severe Burn Patients
Peer Bullying Intervention, Vodcast
Not yet recruitingObservational study
Comparative Study of the Genomic Characteristics of Uropathogenic Escherichia Coli According to the Severity of Community-Acquired Urinary Tract Infections in Guadeloupe (COLIGENURI)
Urinary Tract Infections
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Enrique Cervantes-Perez, MD and MSc study director
Hospital Civil de Guadalajara
Mariana Chávez-Tostado, BS Nutrition, MSc and PhD study director
University of Guadalajara
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Curcumin in people with Sepsis, run by Hospital Civil de Guadalajara at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kevin S Herrmann-Villatoro, Doctor of Medicine (MD) (+52 322 120 9720, kherrmannv99@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Interleukin-6 (IL-6) from baseline to Day 10 of treatment. (time frame: Baseline to Day 10). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07436130, which also lists 79 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.