Actively Recruiting

Phase Not Applicable
Age: 18Years - 60Years
All Genders
NCT07293767

Silymarin vs Hesperidin/Diosmin in Fibromyalgia

Led by Ain Shams University · Updated on 2025-12-19

90

Participants Needed

1

Research Sites

110 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Silymarin vs Hesperidin/Diosmin in Fibromyalgia

Who Can Participate

Age: 18Years - 60Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Provided informed written consent
  • Meets American College of Rheumatology 2016 criteria for fibromyalgia: Widespread Pain Index (WPI) 63 7 and Symptom Severity (SS) scale 63 5, or WPI 3 to 6 and SS scale 63 9
  • Aged over 18 years (male or female)
  • Fibromyalgia diagnosis confirmed by a rheumatologist
  • Persistent pain despite conventional therapy
  • Not taken Daflon or Legalon for the past 6 months
Not Eligible

You will not qualify if you...

  • Pain caused by other conditions like diabetic peripheral neuropathic pain or post-herpetic neuralgia
  • Widespread inflammatory musculoskeletal disorders such as rheumatoid arthritis or lupus
  • Allergy to silymarin, diosmin, or hesperidin
  • Cognitive difficulties affecting understanding or adherence
  • Pregnant, planning pregnancy, or breastfeeding
  • Major health issues like kidney problems, severe liver disease, chronic hepatitis C, or history of addiction
  • Severe or uncontrolled depression or anxiety disorders
  • Noncompliance with medication

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

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

Cairo, Egypt

Actively Recruiting

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Research Team

M

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

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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