None listed
Conditions
Brief summary
This is a Phase III multicenter clinical trial of the herbal oral component of Neurotec in patients with Fibromyalgia.The intervention period is 8 weeks and patients will be followed for another 8 weeks after the end of intervention. This study will be conducted with control group with Placebo.
Interventions
Adminstration of Oral form of herbal component ''Neurotec'' as capsules containing 120mg of active ingredient(which belong to Flavonoids:Isoquercetin,4-Methoxyisoquercetin and Rutin) in patients with diagnosis of fibromyalgia according to American College of Rheumatology (ACR) criteria. Patients will take the drug as oral, twice a day for 8 weeks.
Sponsors
Iran Rheumatology Center
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Diagnosis of Fibromyalgia defined by American college of Rheumatology criteria (Tenderness on at least 11 out of 18 points) Age more than 18 year
Exclusion criteria
Presence of any other rheumatologic diseases Receiving any investigational drug within 30 days prior to screening Presence of any other systemic or chronic diseases such as: Myopathy, Vasculitis, Peripheral Vascular Diseases, Chronic hepatic or renal diseases, clinically complicating pulmonary, Cardiac, Hematologic, Gastrointestinal, Endocrine disease or Malignancy. Pregnancy or intention of becoming pregnant during the study period (1 year) Inability to give informed consent according to the agreed process Corticosteroid therapy Any drug hypersensitivity Radiotherapy, Chemotherapy or any immuosuppressive drug use Electrolyte imbalance
Outcome results
None listed