Silymarin vs Hesperidin/Diosmin in Fibromyalgia

NCT07293767 · tracked via the Priya Life Science Egypt tracker

Sponsor

Ain Shams University

Phase

Not applicable

Started

2024-11-16

Last updated

2025-12-19

Condition(s) studied

Fibromyalgia (FM)

Investigational drug(s) / intervention(s)

Silymarin (LEGALON) →Diosmin / Hesperidin (Daflon) →no intervention (control group)

Silymarin (LEGALON): oral silymarin (legalon) 140 mg will be taken 3 times daily for 12 weeks with the standard treatment

Diosmin / Hesperidin (Daflon): Diosmin / Hesperidin (Daflon) 500 mg will be taken once daily for 12 weeks with the standard treatment

no intervention (control group): this group will receive no intervention (only the standard treatment)

Study summary

Fibromyalgia is a chronic disease, characterized by chronic widespread pain, physical exhaustion, sleep problems, and unexplained pain in both joints and muscles. Fibromyalgia's causes still unknown, but there are various risk factors that can cause fibromyalgia such as genetic causes, physical shock, and infections. Fibromyalgia typically presents in young or middle aged females, it occurs in females more than males, and it is characterized with widespread pain throughout the whole body in both sides such as arms, shoulders, head, and abdominal areas. The etiology of fibromyalgia still unclear, but there are several factors such as alterations in the sleep pattern, changes in the neuroendocrine transmitters such as cortisol, growth hormones and serotonin, dysfunction of central and autonomic nervous systems, psychiatric aspects and external stressors . The pain seems to result from neurochemical imbalances in the central nervous system that lead to a "central amplification" of pain perception characterized by allodynia (a heightened sensitivity to stimuli that are not normally painful) and hyperalgesia (an increased response to painful stimuli). this interventional study aims to study effect of silymarin and hesperidin/diosmin combination on fibromyalgia patients and compare their effect with control patients on the following

1. Management of pain.
2. Inflammatory biomarkers.
3. Quality of life.

Eligibility

Sex

ALL

Min age

18 Years

Max age

60 Years

Healthy volunteers

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.

Primary outcome measure(s)

pain assessment through Fibromyalgia impact questionnaire (FIQ) — 4 months
Change in Fibromyalgia impact questionnaire (FIQ) score will be assessed by the end of the study, the score ranges from 0 to 100 higher score means worse condition

Trial sites (1)

Facility	City	Region	Status
Outpatients clinic of department of Internal medicine- Rheumatology unit Ain shams hospitals.	Cairo	Egypt	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07293767 on ClinicalTrials.gov ↗ ← All trials in Egypt