About this trial
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?
Eligibility criteria
Qualifiers
Adult women aged ≥18 years.
Patients with confirmed diagnosis of fibromyalgia, according to 2022 ACR Fibromyalgia criteria.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Curcumin - Piperine
- Placebo
Treatment groups
Sponsors and collaborators
Ain Shams University
Lead sponsor
Sinai University
Sponsor institution