Fibromyalgia (FM)
Conditions
Keywords
Fibromyalgia syndrome, Curcumin- Piperine, MDA, Insulin Resistance, Inflammation, Oxidative stress
Brief 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. 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?
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: A. Patient demographics including age, gender, weight, height, and body mass index (BMI). B. 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. D. Medical history including previous hospitalizations, surgeries, medication history, and known drug allergies. E. 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).
Interventions
DIETARY_SUPPLEMENTCurcumin - Piperine
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).
OTHERPlacebo
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.
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
The placebo tablets will be identical to the active tablets in size, shape, color and other physical properties to prevent participants from identifying their intervention.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult women aged ≥18 years. * Patients with confirmed diagnosis of fibromyalgia, according to 2022 ACR Fibromyalgia criteria.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of pain severity measured by the Visual Analog Scale (VAS) | 3 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The 36-Item Short Form Health Survey (SF-36) | 3 months | 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 |
| Serum inflammatory biomarkers: IL-6 | 3 months | 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). |
| Serum oxidative biomarker: MDA | 3 months | 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). |
| Glycemic markers: HOMA-IR | 3 months | 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). |
| Incidence and severity of treatment-emergent adverse events | 3 months | 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. |
| Change in alanine aminotransferase (ALT) level | 3 months | Serum alanine aminotransferase (ALT) level will be assessed at baseline and after 3 months. ALT will be reported in unit per liter (U/L) |
| Change in aspartate aminotransferase (AST) level | 3 months | Serum aspartate aminotransferase (AST) level will be assessed at baseline and after 3 months. AST will be reported in unit per liter (U/L) |
| Change in serum creatinine level | 3 months | Change in serum creatinine level will be assessed at baseline and after 3 months. Serum creatinine level will be reported in (mg/dL). |
| Change in hemoglobin level | 3 months | Hemoglobin level will be assessed at baseline and after 3 months. Hemoglobin will be reported in (g\\dL). |
| Change in white blood cell count | 3 Months | 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 |
| Change in platelet count | 3 months | Platelet count will be assessed at baseline and after 3 months. Platelet count will be reported as thousand cells per microliter. |
| The Hospital Anxiety and Depression Scale (HADS) | 3 months | 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. |
| The Revised Fibromyalgia Impact Questionnaire (FIQR) | 3 months | 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 |
Countries
Egypt
Contacts
CONTACTMarina W Khalil
Outcome results
None listed