Fibromyalgia Syndrome.
Conditions
Interventions
Intervention 1: Neurotec (capsules containing 120 mg of active gradient) twice a day for 8 weeks. Intervention 2: Placebo (simillar capsule containing inert substance) twice a day.
Neurotec (capsules containing 120 mg of active gradient) twice a day for 8 weeks
Placebo (simillar capsule containing inert substance) twice a day
Sponsors
Pars Roos Company
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Inclusion Criteria: Diagnosis of Fibromyalgia defined by American college of Rheumatology criteria (History of widespread pain has been present for at least three months and 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 (4 months) Inability to give informed consent according to the agreed process Corticosteroid therapy Any drug hypersensitivity Radiotherapy, Chemotherapy or any immuosuppressive drug use Electrolyte imbalance
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Severity of Pain. Timepoint: Baseline, second, 4th, 6th, 8th, 12th and 16th weeks of the study. Method of measurement: Sum of severities of tenderpoint via an 11-point scale (0-10).;Number of tender points. Timepoint: Baseline, second, 4th, 6th, 8th, 12th and 16th weeks of the study. Method of measurement: number of tender points(out of 18 points based on the American College of Rheumatology). | — |
Secondary
| Measure | Time frame |
|---|---|
| Fibromyalgia Severity. Timepoint: Baseline, second, 4th, 6th, 8th, 12th and 16th weeks of the study. Method of measurement: Fibromyalgia Impact Questionnaire (FIQ).;Anxiety. Timepoint: Baseline, 4th, 8th, and 16th week. Method of measurement: Cattell Anxiety Scale.;Depression. Timepoint: Baseline, 4th, 8th, and 16th week. Method of measurement: Beck Depression Inventory.;Quality of Life. Timepoint: Baseline, 4th, 8th, and 16th week. Method of measurement: SF-12.;Sleep. Timepoint: Baseline, 4th, 8th, and 16th week. Method of measurement: Separate questions of adequacy and quality of sleep.;Patient's Global Impression Change (PGIC). Timepoint: At the end of 8th and 16th week. Method of measurement: 10-point Likert scale (very poor to very improved).;Clinical Global Impression of Change (CGIC). Timepoint: At the end of 8th and 16th week. Method of measurement: 10-point Likert scale (very poor to very improved).;Adverse effects. Timepoint: Baseline, second, 4th, 6th, 8th, 12th and 16th weeks of the study. Method of measurement: Patient's reports and physical examination and lab tests. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactAhmad Reza Jamshidi
Tehran University of Medical Sciences
Outcome results
None listed