PCOPhase 2NCT05952349
Effect of Metformin and Combination of Olive Oil Plus Nutritional Supplements on Inflammatory Markers IL-6 and IL-8 in PCOS.
A Phase 2 study testing OLIVE OIL 5ML/5MG (BD) NUTRITIONAL SACHET 2100MG (BD) and Metformin (1000 mg Twice a day) in people with PCO, run by Khyber Medical University Peshawar at 1 site in Pakistan.
Trial summary
The investigators aim is to conduct randomized clinical trial, to determine the effects of metformin and combination of olive oil plus nutritional supplements on inflammatory markers IL-8 and IL6 in polycystic ovarian syndrome (PCOS). Read more about this study
- Who is it for?
- Ages 18 to 34 years, women only
- Conditions the study is for
- PCO
- What is being tested?
- OLIVE OIL 5ML/5MG (BD) NUTRITIONAL SACHET 2100MG (BD) and Metformin (1000 mg Twice a day)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jul 2023to 1 Apr 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 to 34 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women diagnosed according to Rotterdam criteria (2 out of 3 should be present)
- Hyperandrogenism
- Polycystic ovaries
- Menstrual irregularities
- Age 18-34 years
Who cannot join
- Previous history of Cushing's syndrome
- Women using other medications simultaneously which may affect hormonal changes
- Previous history of ovarian surgery
- Congenital adrenal hyperplasia
- Thyroid diseases
- Autoimmune diseases
- •
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Gynecology and Obstetric, Hayatabad Medical Complex
Peshawar, Khyber Pakhtunkhwa, 25000
About this study
The investigators aim is to conduct randomized clinical trial, to determine the effects of metformin and combination of olive oil plus nutritional supplements on inflammatory markers IL-8 and IL6 in polycystic ovarian syndrome (PCOS). Women diagnosed with PCOS using "Rotterdam diagnostic criteria" according to which two out of three characters must be their in women of PCOS. The investigators propose that PCOS women have increase levels of IL-6 ,IL-8 and this therapy would have beneficial effects and is able to reduce their increase interleukins levels .
Read the detailed description
Poly cystic ovary syndrome (PCOS) is an endocrine and metabolic disorder, it affects approximately 4% to 7% of women of child bearing age. PCOS is characterized by poly cystic ovaries, an-ovulation, and other associated features of hyperandrogenism It is pro inflammatory state which is related to insulin resistance, irregular menstruation(oligomenorrhea), type II diabetes, hyperinsulinemia and increased hair growth as signs and symptoms An anti-hyperglycemic agent such as Metformin improves glucose tolerance, and at cellular levels increase the action of insulin without affecting it's secretion. Insulin resistance, hyperinsulinemia and lipid abnormalities are managed by treatment with metformin. Several studies indicate a positive effect of metformin on both metabolic and reproductive aspects in female having PCOS. Metformin is known to reduce obesity and decrease other inflammatory biomarkers like serum c-reactive protein in female having PCOS.
L-carnitine is synthesized by the human body as an endogenous compound, it plays a very important role in the metabolism of fatty acid. L-Carnitine is a cofactor and it help in the oxidation of fatty acids by transporting long-chain of fatty acids across mitochondrial membrane. LC levels are found reduced in patients having PCOS; therefore, for the proper management for insulin resistance and obesity in women adjunctive therapy of LC could be beneficial.
Recent studies on olive oil shows that it helps in reducing fatty liver, while olive oil consumption had no effects on the lipid profile. Olive oil has excellent anti-inflammatory potentials against IL-6,IL-8 and TNF produced into the bloodstream as compared to metformin. As a result, it can be used in PCOS treatment.
IL-6 shows an essential part in endocrine system as a major pro-inflammatory cytokine, particularly related to ovarian growth and the course of fertilization and implantation. IL-6 is involved in low grade chronic inflammation in female with PCOS2. IL-6 also showed to have an effect on insulin resistance and cardiovascular abnormalities . Elevated IL-6 levels is reported to be associated with increase weight, a major risk factor for type II diabetes.
IL-8 is proinflammatory cytokine.Il-8 is chemoattractant and it activate neutrophils. Proinflammatory markers like il-6 and il-8 are involved in the development in development of insulin resistance in PCO. Insulin resistance is involved in exaggeration of inflammatory process.
Arginine is amino acid by nature. It is an essential substrate for nitric oxide synthesis which is involved in insulin signaling. Its supplementation can improve metabolic disorders, immune function, wound healing, lean tissue mass, and brown adipose tissue growth.Co-q10 act as a cofactor in the electron transport chain and in the series of redox reaction which are crucial in the synthesis of adenosine tri phosphate. Co-Q10 is essential of the health of almost all organs and tissues because ATP is the soul requirement of all cellular functions. Coq-10 is the most important lipid antioxidants, it guards against the formation of free radicals and their alterations to proteins, lipids, and DNA.
PCOS is an anti-inflammatory condition. Previous studies shows that level of certain cytokines are elevated in individual with PCOS. Studies related to inflammatory markers and PCOS are very few so, this research will help us in better understanding of inflammatory markers and PCOS and it will also help us in deciding a more better treatment plan for female patients having PCOS.The purpose of this study is to determine the effects of metformin and combination of olive oil plus nutritional supplements after 3 months, on inflammatory markers IL-8 and IL6 in polycystic ovarian syndrome
- Conditions
- PCO
- Being tested
- OLIVE OIL 5ML/5MG (BD) NUTRITIONAL SACHET 2100MG (BD), Metformin (1000 mg Twice a day)
- Keywords
- Metformin, L-Carnitine, Interleukin-6, L-arginine, CoQ-10
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OLIVE OIL 5ML/5MG (BD) NUTRITIONAL SACHET 2100MG (BD)Drug
44 Patients with PCOS receiving olive oil 5ML/5MG (BD) nutritional sachet 2100MG (BD
Metformin (1000 mg Twice a day)Drug
44 Patients with PCOS receiving Metformin 1000mg (BD)
| Study group | Role | What they receive |
|---|---|---|
| Combination Therapy Group | Active comparator | ARM# 1 OLIVE OIL 5ML/5MG (BD) NUTRITIONAL SACHET 2100MG (BD) Receives: Drug: OLIVE OIL 5ML/5MG (BD) NUTRITIONAL SACHET 2100MG (BD) |
| Standard Therapy Group | Other | ARM # 2 METFORMIN 1000MG (BD) Receives: Drug: Metformin (1000 mg Twice a day) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interleukin 6 level
measurement of IL-6 level vis ELISA
Measured: 3 months
Interleukin 8 level
measurement of IL-8 level vis ELISA
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2023
- Study start1 Jul 2023
- Primary completion31 Dec 2023
- Study completion1 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for PCOStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- cross-sectional study
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Khyber Medical University Peshawar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohsin Shah, Khyber Medical University Peshawar
- Investigators
- Mohsin Shah, PHD, Principal investigator, Department of Physiology, Khyber Medical University, Peshawar Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05952349
- Sponsor's protocol ID
- NO:KMU/IBMS/2023/75
- Status last verified
- Sep 2024
- First submitted
- 11 Jul 2023
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ortega-Gonzalez C, Luna S, Hernandez L, Crespo G, Aguayo P, Arteaga-Troncoso G, Parra A. Responses of serum androgen and insulin resistance to metformin and pioglitazone in obese, insulin-resistant women with polycystic ovary syndrome. J Clin Endocrinol Metab. 2005 Mar;90(3):1360-5. doi: 10.1210/jc.2004-1965. Epub 2004 Dec 14.
PubMed 15598674Xu X, Du C, Zheng Q, Peng L, Sun Y. Effect of metformin on serum interleukin-6 levels in polycystic ovary syndrome: a systematic review. BMC Womens Health. 2014 Aug 5;14:93. doi: 10.1186/1472-6874-14-93.
PubMed 25096410Velazquez EM, Mendoza S, Hamer T, Sosa F, Glueck CJ. Metformin therapy in polycystic ovary syndrome reduces hyperinsulinemia, insulin resistance, hyperandrogenemia, and systolic blood pressure, while facilitating normal menses and pregnancy. Metabolism. 1994 May;43(5):647-54. doi: 10.1016/0026-0495(94)90209-7.
PubMed 8177055Hwang KR, Choi YM, Kim JJ, Chae SJ, Park KE, Jeon HW, Ku SY, Kim SH, Kim JG, Moon SY. Effects of insulin-sensitizing agents and insulin resistance in women with polycystic ovary syndrome. Clin Exp Reprod Med. 2013 Jun;40(2):100-5. doi: 10.5653/cerm.2013.40.2.100. Epub 2013 Jun 30.
PubMed 23875167Takemura Y, Osuga Y, Yoshino O, Hasegawa A, Hirata T, Hirota Y, Nose E, Morimoto C, Harada M, Koga K, Tajima T, Yano T, Taketani Y. Metformin suppresses interleukin (IL)-1beta-induced IL-8 production, aromatase activation, and proliferation of endometriotic stromal cells. J Clin Endocrinol Metab. 2007 Aug;92(8):3213-8. doi: 10.1210/jc.2006-2486. Epub 2007 May 15.
PubMed 17504902Sangeeta S. Metformin and pioglitazone in polycystic ovarian syndrome: a comparative study. J Obstet Gynaecol India. 2012 Oct;62(5):551-6. doi: 10.1007/s13224-012-0183-3. Epub 2012 Oct 16.
PubMed 24082557Yahay M, Heidari Z, Allameh Z, Amani R. The effects of canola and olive oils consumption compared to sunflower oil, on lipid profile and hepatic steatosis in women with polycystic ovarian syndrome: a randomized controlled trial. Lipids Health Dis. 2021 Jan 29;20(1):7. doi: 10.1186/s12944-021-01433-9.
PubMed 33514384Peng Z, Sun Y, Lv X, Zhang H, Liu C, Dai S. Interleukin-6 Levels in Women with Polycystic Ovary Syndrome: A Systematic Review and Meta-Analysis. PLoS One. 2016 Feb 5;11(2):e0148531. doi: 10.1371/journal.pone.0148531. eCollection 2016.
PubMed 26849353Abraham Gnanadass S, Divakar Prabhu Y, Valsala Gopalakrishnan A. Association of metabolic and inflammatory markers with polycystic ovarian syndrome (PCOS): an update. Arch Gynecol Obstet. 2021 Mar;303(3):631-643. doi: 10.1007/s00404-020-05951-2. Epub 2021 Jan 13.
PubMed 33439300Wu G, Meininger CJ, McNeal CJ, Bazer FW, Rhoads JM. Role of L-Arginine in Nitric Oxide Synthesis and Health in Humans. Adv Exp Med Biol. 2021;1332:167-187. doi: 10.1007/978-3-030-74180-8_10.
PubMed 34251644Saini R. Coenzyme Q10: The essential nutrient. J Pharm Bioallied Sci. 2011 Jul;3(3):466-7. doi: 10.4103/0975-7406.84471. No abstract available.
PubMed 21966175
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Metformin and Combination of Olive Oil Plus Nutritional Supplements on Inflammatory Markers IL-6 and IL-8 in PCOS.
- ClinicalTrials.gov ID
- NCT05952349
- Acronym / sponsor ID
- NO:KMU/IBMS/2023/75
- Conditions
- PCO
- Keywords
- Metformin, L-Carnitine, Interleukin-6, L-arginine, CoQ-10
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Khyber Medical University PeshawarUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 19 Jul 2023 (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.
The investigators aim is to conduct randomized clinical trial, to determine the effects of metformin and combination of olive oil plus nutritional supplements on inflammatory markers IL-8 and IL6 in polycystic ovarian syndrome (PCOS). Women diagnosed with PCOS using "Rotterdam diagnostic criteria" according to which two out of three characters must be their in women of PCOS. The investigators propose that PCOS women have increase levels of IL-6 ,IL-8 and this therapy would have beneficial effects and is able to reduce their increase interleukins levels .
Detailed description
Poly cystic ovary syndrome (PCOS) is an endocrine and metabolic disorder, it affects approximately 4% to 7% of women of child bearing age. PCOS is characterized by poly cystic ovaries, an-ovulation, and other associated features of hyperandrogenism It is pro inflammatory state which is related to insulin resistance, irregular menstruation(oligomenorrhea), type II diabetes, hyperinsulinemia and increased hair growth as signs and symptoms An anti-hyperglycemic agent such as Metformin improves glucose tolerance, and at cellular levels increase the action of insulin without affecting it's secretion. Insulin resistance, hyperinsulinemia and lipid abnormalities are managed by treatment with metformin. Several studies indicate a positive effect of metformin on both metabolic and reproductive aspects in female having PCOS. Metformin is known to reduce obesity and decrease other inflammatory biomarkers like serum c-reactive protein in female having PCOS.
L-carnitine is synthesized by the human body as an endogenous compound, it plays a very important role in the metabolism of fatty acid. L-Carnitine is a cofactor and it help in the oxidation of fatty acids by transporting long-chain of fatty acids across mitochondrial membrane. LC levels are found reduced in patients having PCOS; therefore, for the proper management for insulin resistance and obesity in women adjunctive therapy of LC could be beneficial.
Recent studies on olive oil shows that it helps in reducing fatty liver, while olive oil consumption had no effects on the lipid profile. Olive oil has excellent anti-inflammatory potentials against IL-6,IL-8 and TNF produced into the bloodstream as compared to metformin. As a result, it can be used in PCOS treatment.
IL-6 shows an essential part in endocrine system as a major pro-inflammatory cytokine, particularly related to ovarian growth and the course of fertilization and implantation. IL-6 is involved in low grade chronic inflammation in female with PCOS2. IL-6 also showed to have an effect on insulin resistance and cardiovascular abnormalities . Elevated IL-6 levels is reported to be associated with increase weight, a major risk factor for type II diabetes.
IL-8 is proinflammatory cytokine.Il-8 is chemoattractant and it activate neutrophils. Proinflammatory markers like il-6 and il-8 are involved in the development in development of insulin resistance in PCO. Insulin resistance is involved in exaggeration of inflammatory process.
Arginine is amino acid by nature. It is an essential substrate for nitric oxide synthesis which is involved in insulin signaling. Its supplementation can improve metabolic disorders, immune function, wound healing, lean tissue mass, and brown adipose tissue growth.Co-q10 act as a cofactor in the electron transport chain and in the series of redox reaction which are crucial in the synthesis of adenosine tri phosphate. Co-Q10 is essential of the health of almost all organs and tissues because ATP is the soul requirement of all cellular functions. Coq-10 is the most important lipid antioxidants, it guards against the formation of free radicals and their alterations to proteins, lipids, and DNA.
PCOS is an anti-inflammatory condition. Previous studies shows that level of certain cytokines are elevated in individual with PCOS. Studies related to inflammatory markers and PCOS are very few so, this research will help us in better understanding of inflammatory markers and PCOS and it will also help us in deciding a more better treatment plan for female patients having PCOS.The purpose of this study is to determine the effects of metformin and combination of olive oil plus nutritional supplements after 3 months, on inflammatory markers IL-8 and IL6 in polycystic ovarian syndrome
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- cross-sectional study
| Arm | Type | Receives |
|---|---|---|
| Combination Therapy Group | Active comparator | Drug: OLIVE OIL 5ML/5MG (BD) NUTRITIONAL SACHET 2100MG (BD)ARM# 1 OLIVE OIL 5ML/5MG (BD) NUTRITIONAL SACHET 2100MG (BD) |
| Standard Therapy Group | Other | Drug: Metformin (1000 mg Twice a day)ARM # 2 METFORMIN 1000MG (BD) |
Who may qualify
- Ages
- 18 to 34 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Women diagnosed according to Rotterdam criteria (2 out of 3 should be present)
- Age 18-34 years
Key exclusion criteria (7 listed)
- Previous history of Cushing's syndrome
- Women using other medications simultaneously which may affect hormonal changes
- Previous history of ovarian surgery
- Congenital adrenal hyperplasia
- Thyroid diseases
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 |
|---|---|---|
| OLIVE OIL 5ML/5MG (BD) NUTRITIONAL SACHET 2100MG (BD)44 Patients with PCOS receiving olive oil 5ML/5MG (BD) nutritional sachet 2100MG (BD | Drug | Combination Therapy Group |
| Metformin (1000 mg Twice a day)44 Patients with PCOS receiving Metformin 1000mg (BD) | Drug | Standard Therapy Group |
Primary outcome
Interleukin 6 level
Time frame: 3 months
measurement of IL-6 level vis ELISA
Interleukin 8 level
Time frame: 3 months
measurement of IL-8 level vis ELISA
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Background: PubMed 15598674Ortega-Gonzalez C, Luna S, Hernandez L, Crespo G, Aguayo P, Arteaga-Troncoso G, Parra A. Responses of serum androgen and insulin resistance to metformin and pioglitazone in obese, insulin-resistant women with polycystic ovary syndrome. J Clin Endocrinol Metab. 2005 Mar;90(3):1360-5. doi: 10.1210/jc.2004-1965. Epub 2004 Dec 14.
- Background: PubMed 25096410Xu X, Du C, Zheng Q, Peng L, Sun Y. Effect of metformin on serum interleukin-6 levels in polycystic ovary syndrome: a systematic review. BMC Womens Health. 2014 Aug 5;14:93. doi: 10.1186/1472-6874-14-93.
- Background: PubMed 8177055Velazquez EM, Mendoza S, Hamer T, Sosa F, Glueck CJ. Metformin therapy in polycystic ovary syndrome reduces hyperinsulinemia, insulin resistance, hyperandrogenemia, and systolic blood pressure, while facilitating normal menses and pregnancy. Metabolism. 1994 May;43(5):647-54. doi: 10.1016/0026-0495(94)90209-7.
- Background: PubMed 23875167Hwang KR, Choi YM, Kim JJ, Chae SJ, Park KE, Jeon HW, Ku SY, Kim SH, Kim JG, Moon SY. Effects of insulin-sensitizing agents and insulin resistance in women with polycystic ovary syndrome. Clin Exp Reprod Med. 2013 Jun;40(2):100-5. doi: 10.5653/cerm.2013.40.2.100. Epub 2013 Jun 30.
- Background: PubMed 17504902Takemura Y, Osuga Y, Yoshino O, Hasegawa A, Hirata T, Hirota Y, Nose E, Morimoto C, Harada M, Koga K, Tajima T, Yano T, Taketani Y. Metformin suppresses interleukin (IL)-1beta-induced IL-8 production, aromatase activation, and proliferation of endometriotic stromal cells. J Clin Endocrinol Metab. 2007 Aug;92(8):3213-8. doi: 10.1210/jc.2006-2486. Epub 2007 May 15.
- Background: PubMed 24082557Sangeeta S. Metformin and pioglitazone in polycystic ovarian syndrome: a comparative study. J Obstet Gynaecol India. 2012 Oct;62(5):551-6. doi: 10.1007/s13224-012-0183-3. Epub 2012 Oct 16.
- Background: PubMed 33514384Yahay M, Heidari Z, Allameh Z, Amani R. The effects of canola and olive oils consumption compared to sunflower oil, on lipid profile and hepatic steatosis in women with polycystic ovarian syndrome: a randomized controlled trial. Lipids Health Dis. 2021 Jan 29;20(1):7. doi: 10.1186/s12944-021-01433-9.
- Background: PubMed 26849353Peng Z, Sun Y, Lv X, Zhang H, Liu C, Dai S. Interleukin-6 Levels in Women with Polycystic Ovary Syndrome: A Systematic Review and Meta-Analysis. PLoS One. 2016 Feb 5;11(2):e0148531. doi: 10.1371/journal.pone.0148531. eCollection 2016.
- Background: PubMed 33439300Abraham Gnanadass S, Divakar Prabhu Y, Valsala Gopalakrishnan A. Association of metabolic and inflammatory markers with polycystic ovarian syndrome (PCOS): an update. Arch Gynecol Obstet. 2021 Mar;303(3):631-643. doi: 10.1007/s00404-020-05951-2. Epub 2021 Jan 13.
- Background: PubMed 34251644Wu G, Meininger CJ, McNeal CJ, Bazer FW, Rhoads JM. Role of L-Arginine in Nitric Oxide Synthesis and Health in Humans. Adv Exp Med Biol. 2021;1332:167-187. doi: 10.1007/978-3-030-74180-8_10.
- Background: PubMed 21966175Saini R. Coenzyme Q10: The essential nutrient. J Pharm Bioallied Sci. 2011 Jul;3(3):466-7. doi: 10.4103/0975-7406.84471. No abstract available.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Mohsin Shah, PHD principal investigator
Department of Physiology, Khyber Medical University, Peshawar Pakistan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing OLIVE OIL 5ML/5MG (BD) NUTRITIONAL SACHET 2100MG (BD) and Metformin (1000 mg Twice a day) in people with PCO, run by Khyber Medical University Peshawar at 1 site in Pakistan.
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 5 inclusion and 7 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: finished, as of the sponsor's last update on 19 Sep 2024. 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 Pakistan. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Interleukin 6 level (time frame: 3 months). The study lists 2 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 NCT05952349, which also lists 11 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 19 Sep 2024.