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IRCT20200920048782N2 IRCT 2021-10-04 Guilan University of Medical Sciences Effect of vitamin B6 in treatment of fibromyalgia Comparison the effectiveness of vitamin B6 and placebo in pain, psychological symptoms and inflammatory biomarkers of patients with fibromyalgia 2021-09-23 anticipated 90 Complete https://irct.ir/trial/58341 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Using stratified randomization, Patients will be assigned to three strata based on their disease severity, which is obtained from Revised fibromyalgia impact questionnaire (mild:0-39, moderate: 40-59, severe: 60-100). Thereafter, through permuted block randomization, 3 blocks, each containing 30 participants will be formed. Each strata has one block with 30 patients with equal distribution (15 patients from interventional group and 15 patients from placebo). Random sequence will be generated using www.Randomization.com. For allocation concealment, sequentially numbered, sealed, opaque envelops will be used. patients, will be initially evaluated for their disease severity and will receive either bottle A or B, according to their strata sequence, Blinding description: Active drug and placebo will be kept in completely identical (in shape, color, size and taste) plum bottles, codded as either A or B. No other person, except for the statistical analyst, including participants, principal investigator, physician, data collectors, outcome assessors, and manuscript writers are not aware of the bottles' content. Statistical analyst doesn't have any involvement in the process of the study and will join the study when the data gathering process is completely finished. 3 Fibromyalgia. Intervention 1: Intervention group: Patients will receive pills of vitamin B6 (40mg, Iran homone company) twice daily, for 60 days. Intervention 2: Control group: Patients will receive pills with same shape as vitaminB6 (lactose monohydrate(78%), corn starch(20%), aerosil (0.5%), talc (1%) and magnesium stearate (0.5%), produced under standard condition by Pharmacology faculty of Guilan university of medical sciences), twice daily for 60 days. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Faeze Gharibpoor
No. 33, gohari alley, moalem blv
Rasht Iran (Islamic Republic of) 4155646515 +98 13 3357 2495 faezegharibpoor@gmail.com Rasht University of Medical Sciences scientific Faeze Gharibpoor
No. 33, gohari alley, moalem blv
Rasht Iran (Islamic Republic of) 4155646515 +98 13 3357 2495 faezegharibpoor@gmail.com Rasht University of Medical Sciences Iran (Islamic Republic of) Patients with fibromyalgia diagnosis based on a rheumatologist opinion fulfilled American college of rheumatology 2016 criteria (ACR 2016) 18 years no limit Both Patients under 18 years old Being pregnant or breastfeeding Patients suffering from comorbidities with chronic pain and inflammation (e.g., recent major trauma, malignancy, other rheumatic disease) Patients with psychological disorders except depression and anxiety Patients without consent to participate the study M79.7 Fibromyalgia Treatment - Drugs Placebo Intervention group: Patients will receive pills of vitamin B6 (40mg, Iran homone company) twice daily, for 60 days Control group: Patients will receive pills with same shape as vitaminB6 (lactose monohydrate(78%), corn starch(20%), aerosil (0.5%), talc (1%) and magnesium stearate (0.5%), produced under standard condition by Pharmacology faculty of Guilan university of medical sciences), twice daily for 60 days. Disease severity. Timepoint: Before intervention and 60 days after intervention. Method of measurement: Revised fibromyalgia impact questionnaire (FIQR). Psychological symptoms. Timepoint: Before intervention and 60 days after intervention. Method of measurement: Hospital anxiety and depression scale (HADS). Pain intensity. Timepoint: Before intervention and 60 days after intervention. Method of measurement: Pain visual analogue scale (VAS). Health related quality of life. Timepoint: Before intervention and 60 days after intervention. Method of measurement: Short-form health survey (SF-12). Inflammation. Timepoint: Before intervention and 60 days after intervention. Method of measurement: ESR. Inflammation. Timepoint: Before intervention and 60 days after intervention. Method of measurement: Platelet distribution width (PDW). Inflammation. Timepoint: Before intervention and 60 days after intervention. Method of measurement: Mean platelet volume (MPV). Inflammation. Timepoint: Before intervention and 60 days after intervention. Method of measurement: Neutrophil leukocyte ratio (NLR). Guilan University of Medical Sciences Approved 2021-09-15 Research ethic committes of Guilan university of medical sciences Student research committee, Deputy of Research and Technology, Namjoo st. Rasht Guilan Iran (Islamic Republic of)