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IRCT138708061411N2 IRCT 2009-06-16 Pars Roos Company Multi-Centre Randomised Double Blind Placebo Controlled Clinical Trial of the Effect of Neurotec in Fibromyalgia Syndrome Multi-Centre Randomised Double Blind Placebo Controlled Clinical Trial of the Effect of Neurotec in Fibromyalgia Syndrome 2008-11-24 anticipated 200 Complete https://irct.ir/trial/662 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment. 3 Fibromyalgia Syndrome. 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.
public Ahmad Reza Jamshidi
Rheumatology Research Centre, Dr Shariati Hospital, North Kargar Avenue, Tehran
Tehran Iran (Islamic Republic of) 14114 +98 21 8490 2405 jamshida@tums.ac.ir Tehran University of Medical Sciences scientific Ahmad Reza Jamshidi
Rheumatology Research Centre, Shariati Hospital, North Kargar St.,
Tehran Iran (Islamic Republic of) 14114 +98 21 8490 2405 jamshida@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) 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 18 years 75 years Both Neurotec (capsules containing 120 mg of active gradient) twice a day for 8 weeks Placebo (simillar capsule containing inert substance) twice a day 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). 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. Pars Roos Company Approved Endocrine & Metabolism Research Center, Ethic Committe Fifth Floor, Shariati Hospital, North Kargar St., Tehran, Iran Tehran Iran (Islamic Republic of)