Fibromyalgia Clinical Trials

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

Status: Recruiting
Location: See location...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Egypt
Outpatients clinic of department of Internal medicine- Rheumatology unit Ain shams hospitals.
RECRUITING
Cairo
Contact Information
Primary
menna s teaching assistant of clinical pharmacy/ master's student
mssalama@msa.edu.eg
01064897439
Time Frame
Start Date: 2024-11-16
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 90
Treatments
Experimental: Silymarin group
this group of patients will receive silymarin (LEGALON) 140 mg three times daily with the standard treatment
Experimental: Diosmin/hisperedin group
this group will receive hesperidin/diosmin (daflon) 500 once daily for 12 weeks with the standard treatment
Active_comparator: Standard care group
participants will receive standard treatment only
Related Therapeutic Areas
Sponsors
Leads: Ain Shams University

This content was sourced from clinicaltrials.gov