Silymarin vs Hesperidin/Diosmin in Fibromyalgia

NCT07293767 | Recruiting

• 1 other identifier: FM
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Conditions

Fibromyalgia (FM)

Keywords

fibromyalgia; silymarin; hesperidin; diosmin

Outcome Measures

Primary Outcomes (1)

• pain assessment through Fibromyalgia impact questionnaire (FIQ)

  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

  4 months

Secondary Outcomes (5)

• Erythrocyte sedimentation rate (ESR)

  4 months

• C-reactive protein level (CRP)

  4 months

• Health-related quality-of-life through Short Form 12 health survey SF-12

  4 months

• pain assessment through visual analogue scale (VAS)

  4 months

• laboratory evaluation of interleukin- 8 (IL-8) level

  4 months

Study Arms (3)

Silymarin group

EXPERIMENTAL

this group of patients will receive silymarin (LEGALON) 140 mg three times daily with the standard treatment

Drug: Silymarin (LEGALON)

Diosmin/hisperedin group

EXPERIMENTAL

this group will receive hesperidin/diosmin (daflon) 500 once daily for 12 weeks with the standard treatment

Drug: Diosmin / Hesperidin (Daflon)

Standard care group

ACTIVE COMPARATOR

participants will receive standard treatment only

Other: no intervention (control group)

Interventions

Silymarin (LEGALON) DRUG

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

Silymarin group

Diosmin / Hesperidin (Daflon) DRUG

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

Diosmin/hisperedin group

no intervention (control group) OTHER

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

Standard care group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Outpatients clinic of department of Internal medicine- Rheumatology unit Ain shams hospitals.

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Fibromyalgia

Interventions

Silymarin; Diosmin; Hesperidin; Control Groups

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Flavonolignans; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Flavones; Flavanones; Glycosides; Carbohydrates; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

menna s teaching assistant of clinical pharmacy/ master's student

CONTACT

01064897439; mssalama@msa.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: pharmacist

Model Details: Group I: 30 patients will receive their standard treatment of fibromyalgia for four months. Group II: 30 patients will receive 500 mg of diosmin/ hesperidine combination under the trade name of daflon with their standard treatment of fibromyalgia for four months. Group III: 30 patients will receive 140 mg of silymarin three times daily under the trade name of Legalon with their standard treatment for four months.

Study Record Dates

• First Submitted: November 25, 2025
• First Posted: December 19, 2025
• Study Start: November 16, 2024
• Primary Completion: January 15, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 19, 2025

Record last verified: 2025-12

Locations

EG (1)