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RECRUITING
NCT07293767
NA

Silymarin vs Hesperidin/Diosmin in Fibromyalgia

Sponsor: Ain Shams University

View on ClinicalTrials.gov

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.

Official title: The Effect of Silymarin Versus Hesperidin/Diosmin Combination on Patients With Fibromyalgia

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

90

Start Date

2024-11-16

Completion Date

2026-12-31

Last Updated

2025-12-19

Healthy Volunteers

No

Interventions

DRUG

Silymarin (LEGALON)

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

DRUG

Diosmin / Hesperidin (Daflon)

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

OTHER

no intervention (control group)

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

Locations (1)

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

Cairo, Egypt