Silymarin versus hesperidin/diosmin for fibromyalgia symptom relief

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults with rheumatologist-confirmed fibromyalgia who meet the ACR 2016 criteria and have persistent symptoms despite conventional treatment will be assigned to receive silymarin (Legalon), a diosmin/hesperidin combination (Daflon), or no active treatment (control). Participants must be older than 18 and not have used Daflon or Legalon in the prior six months; those with other widespread inflammatory or neuropathic pain conditions or allergies to the study compounds are excluded. Symptoms and pain burden will be followed using standard fibromyalgia measures (including Widespread Pain Index and symptom severity scoring) over the treatment period. The trial is conducted at the Rheumatology outpatient unit of Ain Shams Hospitals in Cairo.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Informed written consent.
* Participant must meet the American College of Rheumatology 2016 revised classification criteria for Fibromyalgia: Widespread pain index (WPI) ≥ 7 and symptom severity (SS) scale score ≥ 5, or WPI 3 to 6 and SS scale score ≥ 9
* Age \>18 years old (males and females)
* Diagnosis of FM confirmed by a rheumatologist.
* Persistent pain syndrome on conventional therapy.
* Not taking Daflon or Legalon for 6 months.

Exclusion Criteria:

* Pain due to other conditions (e.g. diabetic peripheral neuropathic pain or post-herpetic neuralgia) that would confound assessment or self-evaluation of the pain associated with FM.
* Patients with pain due to any widespread inflammatory musculoskeletal disorder (e.g. rheumatoid arthritis, lupus) or widespread rheumatic disease other than FM.
* Allergy to silymarin or diosmin or hesperidin.
* Cognitive deficits that could impair understanding of the study, completion of questionnaires, or adherence to therapy.
* Pregnant or planning pregnancy women and breastfeeding women.
* Major comorbidities like renal impairment, severe liver disease, chronic hepatitis C, history of alcohol or drug addiction.
* Current severe or uncontrolled major depressive disorder or anxiety disorders.
* Patients will be excluded if there is no compliance to the medication.

Where it's running

• Outpatients clinic of department of Internal medicine- Rheumatology unit Ain shams hospitals.
  Cairo, Egypt Recruiting

Study contacts

• Study coordinator: menna s teaching assistant of clinical pharmacy/ master's student
• Email: mssalama@msa.edu.eg
• Phone: 01064897439

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.