drugset / Trial / NCT07293767

Silymarin vs Hesperidin/Diosmin in Fibromyalgia

NCT07293767

Recruiting 90 enrolled Ain Shams University
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2024-11-16
Primary completion
2026-01-15
Completion
2026-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Diosmin / Hesperidin Unknown 500 mg Oral
Subject Silymarin Traditional medicine (herbal / TCM) 140 mg Oral

Indications