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Fibromyalgia (FM)Phase 2NCT07753018

Effects of Curcumin-Piperine Supplementation in Fibromyalgia

A Phase 2 study testing Curcumin - Piperine in people with Fibromyalgia (FM), run by Ain Shams University at 1 site in Egypt.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The goal of this clinical trail is to evaluate the effectiveness and safety of curcumin-piperine supplementation in patients with fibromyalgia over 3 months compared to placebo. Participants will: Be randomly assigned to receive either curcumin and piperine supplements or a placebo. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Fibromyalgia (FM)
What is being tested?
Curcumin - Piperine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
80 participants
Where
1 siteEgypt
Study dates
1 Aug 2026to 1 Aug 2027
Phase
Phase 2
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
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult women aged ≥18 years.
  • Patients with confirmed diagnosis of fibromyalgia, according to 2022 ACR Fibromyalgia criteria.

Who cannot join

  • Diabetic patients (HbA1c ≥ 6.5).
  • Patients with chronic inflammatory or autoimmune diseases other than FM.
  • Patients allergic to curcumin or piperine.
  • Patients receiving other anti-inflammatory medications.
  • Severe hepatic or renal impairment.
  • Patients receiving anticoagulant medications (e.g., clopidogrel).
  • Pregnancy or lactation.
  • Participation in another clinical trial

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Marina W Khalil contact

+201222157176

marina12william@gmail.com

Egypt1 site

  • Suez Canal University hospitals

    Ismailia, 41511

    Rheumatology and Rehabilitation Outpatient Clinic, +201277884948

    marina w khalil, M.Sc candidate

Other trials in Egypt

About this study

Official title: Evaluation of the Effect of Curcumin and Piperine Supplementation on Clinical Outcome in Fibromyalgia Patients.

The goal of this clinical trail is to evaluate the effectiveness and safety of curcumin-piperine supplementation in patients with fibromyalgia over 3 months compared to placebo.

Participants will:

Read more

Be randomly assigned to receive either curcumin and piperine supplements or a placebo.

Attend scheduled clinic visits for clinical assessments and blood sample collection.

Complete study questionnaires before and after treatment time frame.

The primary question the study aim to answer is:

Does Curcumin-piperine supplementation reduce pain intensity by Visual Analog Scale (VAS), compared with placebo?

The secondary questions this study aims to answer are:

Does supplementation improve fibromyalgia disease impact and quality of life? Does supplementation improve inflammatory biomarkers and oxidative stress? Does supplementation improve insulin resistance? Is curcumin and piperine supplementation safe and well tolerated?

Read the detailed description

Fibromyalgia (FM) is a chronic pain disorder characterized by widespread musculoskeletal pain, fatigue, sleep disturbances, cognitive impairment, and mood disorders. Increasing evidence suggests that its pathogenesis is driven by a complex interaction of central sensitization, neuroinflammation, and oxidative stress. Elevated levels of pro-inflammatory cytokines and oxidative stress biomarkers have been linked to pain severity and disease progression. Although current pharmacological therapies can reduce symptoms, their effectiveness is often limited, and they do not adequately address the underlying biological mechanisms.

In addition to inflammation and oxidative stress, insulin resistance (IR) has recently emerged as a potential contributor to fibromyalgia. Several clinical studies have reported higher HOMA-IR values in patients with FM than in healthy individuals, with greater insulin resistance being associated with more severe pain and poorer clinical outcomes. This relationship may be explained by chronic low-grade inflammation, increased oxidative stress, impaired glucose metabolism, and altered central pain processing. These findings suggest that metabolic dysfunction may contribute to symptom persistence and represent an additional therapeutic target in FM.

Curcumin, a natural polyphenol extracted from "Curcuma longa", has attracted considerable interest because of its anti-inflammatory, antioxidant, neuroprotective, and analgesic properties. In addition to reducing inflammatory mediators, oxidative stress, and modulating pain pathways, curcumin has been shown to improve insulin sensitivity and glycemic control, suggesting that it may simultaneously target both the inflammatory and metabolic abnormalities associated with FM.

These findings support the hypothesis that curcumin may improve fibromyalgia by addressing inflammation, oxidative stress, pain sensitization, and metabolic dysfunction. However, current clinical evidence remains limited by small sample sizes and short intervention periods. Furthermore, curcumin's poor oral bioavailability can be markedly enhanced by co-administration with piperine, which increases its intestinal absorption. Therefore, a well-designed randomized controlled trial is needed to evaluate the efficacy and safety of curcumin-piperine supplementation as an adjunctive therapy for patients with fibromyalgia.

A total of 80 fibromyalgia patients will be enrolled in the study. Patients will be stratified according to insulin resistance status (insulin-resistant vs. non-insulin-resistant) followed by permuted block randomization to the study groups. All patients in both groups will receive standard treatment consisting of duloxetine and gabapentin, along with personalized guidance on an anti-inflammatory diet and exercise program.

Participants will be educated about the study and asked to sign a written informed consent before starting the study, assuring that they can withdraw at any time if they want.

The following data will be collected from patient records and by history taking from the patients upon enrollment:

  1. Patient demographics including age, gender, weight, height, and body mass index (BMI).
  2. Clinical variables including HbA1c, and HOMA-IR, complete blood picture, kidney function tests and liver function tests C. Comorbidities including but not limited to diabetes, hypertension, chronic kidney disease, cardiovascular disease, and immunosuppression.
  3. Medical history including previous hospitalizations, surgeries, medication history, and known drug allergies.
  4. Medication history including analgesic consumption (dose, frequency, and duration)

The patients will be followed up by weekly phone calls to encourage adherence and to evaluate the incidence and severity of the adverse effects including GIT disturbances or any other undesirable side effects reported by the patients throughout the trial. In addition, complete blood picture, kidney function tests, and liver function tests will be assessed at baseline, after 1 month and by the end of the study (after 3 months).

Being tested
Curcumin - Piperine, Placebo
Keywords
Fibromyalgia syndrome, Curcumin- Piperine, MDA, Insulin Resistance, Inflammation, Oxidative stress
Medical subject headings
Fibromyalgia, Insulin Resistance, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Curcumin - PiperineDietary supplement

    The experimental group will receive Organic Nation Curcumin® oral coated tablets, administered once daily for 3 months, containing 1,200 mg of standardized curcumin (95% turmeric extract) combined with 10 mg of piperine (95% black pepper extract).

  • PlaceboOther

    the placebo group will receive matching oral placebo tablet containing inert excipients for the same duration. The placebo tablets will be identical in appearance, size, color, and packaging to the active supplement to maintain blinding.

Study groups in NCT07753018
Study groupRoleWhat they receive
Group A (Curcumin Group)ExperimentalThe experimental group will receive Organic Nation Curcumin® oral coated tablets, administered once daily for 3 months, containing 1,200 mg of standardized curcumin (95% turmeric extract) combined with 10 mg of piperine (95% black pepper extract), in addition to the standard treatment.
Receives: Dietary Supplement: Curcumin - Piperine
Group B (Placebo Group)Placebo comparatorParticipants will receive identical-appearing tablets containing inert excipients once daily for 3 months, in addition to the standard treatment.
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Assessment of pain severity measured by the Visual Analog Scale (VAS)

    VAS is a self-administered instrument widely used in fibromyalgia research and clinical practice to assess pain intensity and monitor treatment response. The VAS uses a 10-cm horizontal line anchored by 0 (no pain) and 10 (worst imaginable pain). It will be measured at baseline, after 1 month, and after 3 months.

    Measured: 3 months

Secondary outcomes (13)

  1. The Revised Fibromyalgia Impact Questionnaire (FIQR)

    is a disease-specific, patient-reported outcome measure designed to assess disease severity and the overall impact of fibromyalgia. It comprises 21 items grouped into three domains: function (9 items assessing physical activities), overall impact (2 items evaluating the extent to which fibromyalgia interferes with goal achievement and causes a feeling of being overwhelmed), and symptoms (10 items assessing pain, fatigue, sleep quality, stiffness, depression, anxiety, memory, balance, tenderness, and environmental sensitivity). All items are rated on a 0-10 numeric scale. The total FIQR score ranges from 0 to 100, with higher scores indicating greater disease impact and symptom severity. It will be measured at baseline, after 1 month, and after 3 months

    Measured: 3 months

  2. The Hospital Anxiety and Depression Scale (HADS)

    The scale consists of 14 self-reported items, divided equally into two domains: anxiety (HADS-A) and depression (HADS-D). Each item is rated on a 4-point Likert scale (0-3), yielding subscale scores ranging from 0 to 21, where higher scores indicate greater symptom severity. A cut-off score of ≥8 on either subscale is considered indicative of clinically relevant anxiety or depression. Elevated HADS scores in this population have been consistently associated with higher symptom severity, increased pain intensity, poorer sleep quality, reduced quality of life, and functional impairment. It will be measured at baseline, after 1 month, and after 3 months.

    Measured: 3 months

  3. The 36-Item Short Form Health Survey (SF-36)

    SF-36 is a validated, self-administered, generic instrument used to assess health-related quality of life in fibromyalgia research by evaluating both physical and mental health status. It consists of 36 items covering eight domains: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. Domain scores are transformed to a scale ranging from 0 to 100, where 0 represents the worst and 100 the best perceived health status, and are aggregated into two summary measures: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). It will be measured at baseline, after 1 month, and after 3 months

    Measured: 3 months

  4. Serum inflammatory biomarkers: IL-6

    Collected serum samples will be stored at -80 C until analysis. Serum IL-6 will be assessed using enzyme-linked immunosorbent assay (ELISA) kits. It will be measured at the start and end of the study (after 3 months).

    Measured: 3 months

  5. Serum oxidative biomarker: MDA

    Collected serum samples will be stored at -80oC until analysis. Serum MDA will be assessed for each patient using spectrophotometric assay kits. It will be measured at the start and end of the study (after 3 months).

    Measured: 3 months

  6. Glycemic markers: HOMA-IR

    Insulin resistance will be assessed using the HOMA-IR ( fasting insulin × fasting glucose / 405), which is calculated from fasting glucose and fasting insulin levels. Fasting blood glucose will be measured using an enzymatic colorimetric method, and fasting serum insulin will be determined using ELISA kits.It will be measured at the start and end of the study (after 3 months).

    Measured: 3 months

  7. Incidence and severity of treatment-emergent adverse events

    The patients will be followed up by weekly phone calls to evaluate the incidence and severity of the adverse effects including GIT disturbances or any other undesirable side effects.

    Measured: 3 months

  8. Change in alanine aminotransferase (ALT) level

    Serum alanine aminotransferase (ALT) level will be assessed at baseline and after 3 months. ALT will be reported in unit per liter (U/L)

    Measured: 3 months

  9. Change in aspartate aminotransferase (AST) level

    Serum aspartate aminotransferase (AST) level will be assessed at baseline and after 3 months. AST will be reported in unit per liter (U/L)

    Measured: 3 months

  10. Change in serum creatinine level

    Change in serum creatinine level will be assessed at baseline and after 3 months. Serum creatinine level will be reported in (mg/dL).

    Measured: 3 months

  11. Change in hemoglobin level

    Hemoglobin level will be assessed at baseline and after 3 months. Hemoglobin will be reported in (g\dL).

    Measured: 3 months

  12. Change in white blood cell count

    white blood cell count will be assessed at baseline and after 3 months. white blood cell count will be reported as thousand cells per microliter

    Measured: 3 Months

  13. Change in platelet count

    Platelet count will be assessed at baseline and after 3 months. Platelet count will be reported as thousand cells per microliter.

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Aug 2026
  2. Study start1 Aug 2026 (estimated)
  3. Primary completion20 Jun 2027 (estimated)
  4. Study completion1 Aug 2027 (estimated)

Resources

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
Masking
Single blind
Who is masked
Participant
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07753018
Sponsor's protocol ID
479
Status last verified
Aug 2026
First submitted
4 Aug 2026
Last updated
11 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bennett RM, Friend R, Jones KD, Ward R, Han BK, Ross RL. The Revised Fibromyalgia Impact Questionnaire (FIQR): validation and psychometric properties. Arthritis Res Ther. 2009;11(4):R120. doi: 10.1186/ar2783. Epub 2009 Aug 10.

    PubMed 19664287

  • Vallejo MA, Rivera J, Esteve-Vives J, Rodriguez-Munoz MF; Grupo ICAF. [Use of the Hospital Anxiety and Depression Scale (HADS) to evaluate anxiety and depression in fibromyalgia patients]. Rev Psiquiatr Salud Ment. 2012 Apr-Jun;5(2):107-14. doi: 10.1016/j.rpsm.2012.01.003. Epub 2012 Mar 2. Spanish.

    PubMed 22854581

  • Uslu EY, Uslu MF, Yildiz S, Tabara MF. Evaluating Oxidative Stress in Fibromyalgia: Diagnostic Utility and Its Relationship with Clinical and Psychological Parameters. Medicina (Kaunas). 2025 Jul 10;61(7):1248. doi: 10.3390/medicina61071248.

    PubMed 40731876

  • Tunc Karaman S, Huner B, Basat O. The impact of metabolic health on fibromyalgia: insights from insulin resistance and related indexes. Postgrad Med. 2025 Jan;137(1):28-36. doi: 10.1080/00325481.2024.2439244. Epub 2024 Dec 10.

    PubMed 39635876

  • Terkawi AS, Tsang S, AlKahtani GJ, Al-Mousa SH, Al Musaed S, AlZoraigi US, Alasfar EM, Doais KS, Abdulrahman A, Altirkawi KA. Development and validation of Arabic version of the Hospital Anxiety and Depression Scale. Saudi J Anaesth. 2017 May;11(Suppl 1):S11-S18. doi: 10.4103/sja.SJA_43_17.

    PubMed 28616000

  • Shoba G, Joy D, Joseph T, Majeed M, Rajendran R, Srinivas PS. Influence of piperine on the pharmacokinetics of curcumin in animals and human volunteers. Planta Med. 1998 May;64(4):353-6. doi: 10.1055/s-2006-957450.

    PubMed 9619120

  • Shayan NA, Arslan UE, Hooshmand AM, Arshad MZ, Ozcebe H. The Short Form Health Survey (SF-36): translation and validation study in Afghanistan. East Mediterr Health J. 2020 Aug 25;26(8):899-908. doi: 10.26719/emhj.20.064.

    PubMed 32896884

  • Shahid, A., Wilkinson, K., Marcu, S., & Shapiro, C. M. (2011). Visual Analogue Scale to Evaluate Fatigue Severity (VAS-F). In STOP, THAT and One Hundred Other Sleep Scales (pp. 399-402). Springer New York. https://doi.org/10.1007/978-1-4419-9893-4_100

  • Sarzi-Puttini P, Giorgi V, Marotto D, Atzeni F. Fibromyalgia: an update on clinical characteristics, aetiopathogenesis and treatment. Nat Rev Rheumatol. 2020 Nov;16(11):645-660. doi: 10.1038/s41584-020-00506-w. Epub 2020 Oct 6.

    PubMed 33024295

  • San Mauro Martin, I., López Oliva, S., Collado Yurrita, L., Sanz Rojo, S., & Garicano Vilar, E. (2019). Anti-inflammatory and antioxidant feeding and supplementation may serve as adjuvants in women with fibromyalgia. Journal of Nutrition & Intermediary Metabolism, 15, 3-9. https://doi.org/10.1016/j.jnim.2018.11.002

  • Sahebkar, A., Serban, M. C., Ursoniu, S., & Banach, M. (2015). Effect of curcuminoids on oxidative stress: A systematic review and meta-analysis of randomized controlled trials. In Journal of Functional Foods (Vol. 18, pp. 898-909). Elsevier Ltd. https://doi.org/10.1016/j.jff.2015.01.005

  • Rossello Aubach L, Fornos Roca X, Fernandez Alvarez ME. Effects of Coenzyme Q10, Tryptophan, and Magnesium Supplementation on Fatigue in Patients with Fibromyalgia - A Randomized Trial. J Diet Suppl. 2025;22(3):433-444. doi: 10.1080/19390211.2025.2483269. Epub 2025 Mar 28.

    PubMed 40151031

  • Panahi Y, Sahebkar A, Parvin S, Saadat A. A randomized controlled trial on the anti-inflammatory effects of curcumin in patients with chronic sulphur mustard-induced cutaneous complications. Ann Clin Biochem. 2012 Nov;49(Pt 6):580-8. doi: 10.1258/acb.2012.012040. Epub 2012 Oct 4.

    PubMed 23038702

  • O'Mahony LF, Srivastava A, Mehta P, Ciurtin C. Is fibromyalgia associated with a unique cytokine profile? A systematic review and meta-analysis. Rheumatology (Oxford). 2021 Jun 18;60(6):2602-2614. doi: 10.1093/rheumatology/keab146.

    PubMed 33576773

  • Naghsh N, Musazadeh V, Nikpayam O, Kavyani Z, Moridpour AH, Golandam F, Faghfouri AH, Ostadrahimi A. Profiling Inflammatory Biomarkers following Curcumin Supplementation: An Umbrella Meta-Analysis of Randomized Clinical Trials. Evid Based Complement Alternat Med. 2023 Jan 16;2023:4875636. doi: 10.1155/2023/4875636. eCollection 2023.

    PubMed 36700039

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Curcumin - Piperine in people with Fibromyalgia (FM), run by Ain Shams University at 1 site in Egypt.

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 2 inclusion and 8 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: opening soon, as of the sponsor's last update on 11 Aug 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 Egypt. 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.

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?

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 Marina W Khalil (+201222157176, marina12william@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assessment of pain severity measured by the Visual Analog Scale (VAS) (time frame: 3 months). 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 NCT07753018, which also lists 41 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 11 Aug 2026.

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