Silymarin vs Hesperidin/Diosmin in Fibromyalgia

MI-összefoglaló

A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.

The trial is looking for adults with fibromyalgia who still have pain despite usual treatment. It compares silymarin, hesperidin/diosmin and standard care alone.

Életkor

Over 18 years, up to 60 years.

Nem

Men and women can join.

A betegség stádiuma

Fibromyalgia confirmed by a rheumatologist and meeting the American College of Rheumatology 2016 criteria: WPI ≥ 7 and SS score ≥ 5, or WPI 3 to 6 and SS score ≥ 9. Pain persists on conventional therapy.

Korábbi kezelés

Must be on conventional therapy. Must not have taken Daflon or Legalon for 6 months.

A részvétel fő kizáró okai

• Pain from other conditions, such as diabetic nerve pain or pain after shingles, or from widespread inflammatory or rheumatic diseases like rheumatoid arthritis or lupus.
• Allergy to silymarin, diosmin or hesperidin.
• Pregnant, planning pregnancy or breastfeeding.
• Major other illnesses such as kidney problems, severe liver disease, chronic hepatitis C, or past alcohol or drug addiction.
• Current severe or uncontrolled depression or anxiety, or memory and thinking problems that affect taking part.

A regiszter feltételei, szó szerint

Nézd meg, megfelelhetsz-e

Magadról válaszolj. Ez nem döntés: hogy részt vehetsz-e, azt csak a vizsgálat csapata mondhatja meg.

• 18 és 60 év között vagy?IgenNem

Mit akar kideríteni a vizsgálat

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

A vizsgálat 3 csoportja

• Silymarin groupA vizsgált kezelés

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

  Kezelés: Silymarin (LEGALON)

• Diosmin/hisperedin groupA vizsgált kezelés

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

  Kezelés: Diosmin / Hesperidin (Daflon)

• Standard care groupMár használt kezelés, összehasonlításként

  participants will receive standard treatment only

  Kezelés: no intervention (control group)