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IRCT20181113041646N2 IRCT 2023-11-14 Rasht University of Medical Sciences Effect of B1, B6 and B12 vitamins on fibromyalgia Study of the effect of B1, B6 and B12 vitamins combination on pain and somatic symptoms in patient with fibromyalgia. 2023-11-22 anticipated 64 Complete https://irct.ir/trial/72920 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In order to avoid bias in the selection of patients, the sequencing and distribution of patients into groups A and B is done by Statistics. Then, the type of intervention or placebo of groups A and B is done by someone outside the team of evaluators and analysts. To randomize people in two groups, the method of 4 permutation blocks is used. Considering group A and group B, the randomization process will be as follows. Randomization was done with SAS version 9 software. Seed: 67563107250670 Block sizes: 4 Actual list length: 64 block identifier, block size, sequence within block, treatment • 1, 4, 1, Group B • 1, 4, 2, Group A • 1, 4, 3, Group B • 1, 4, 4, Group A • 2, 4, 1, Group A • 2, 4, 2, Group B • 2, 4, 3, Group B Considering that the current study is double-blind, and the drug and placebo are presented to the performers and patients in similar and non-transparent envelopes, interventional concealment or the fact that groups A and B are placebos means that the allocation is concealed. For this purpose, the choice of intervention or placebo group A and B is done after distributing the names of the patients and by a person who is not aware of the sequence, Blinding description: In this study, in order to avoid bias in the selection of patients, the sequencing and distribution of patients into groups A and B is done by Statistics specialist. Then the type of intervention or placebo group A and B is done by someone outside the team of evaluators and analysts. Also, a colleague outside the group of plan executives, evaluators and analysts is asked to pack the original drug and the placebo, which have the same appearance and quality, in the amount needed for one month (60 pieces) in exactly the same envelopes, dark and closed. place and name them as A and B according to the type of intervention or placebo, and give them to the project managers. In this way, neither the people under study nor the presenters and analysts know about the intervention and placebo groups. 3 Pain and somatic symptoms in fibromyalgia disease. Intervention 1: Intervention group: The first group includes patients with fibromyalgia who receive 100 mg of vitamin B1, 100 mg of vitamin B6 and 200 micrograms of vitamin B12 as a single tablet made by Mahban Daru company, one per day for thirty days. Intervention 2: Control group: This group includes patients suffering from fibromyalgia who receive the placebo manufactured by Subhan Daru company, which contains tablets of the same color, shape and size as the vitamin tablets received by the intervention group for one month and in the amount of one per day. 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 more information.
public Banafshe Ghavidel parsa
Sardr jangal avenue ,razi hospital
Rasht Iran (Islamic Republic of) 4144895655 +98 13 3353 0169 bghavidelparsa@gmail.com Rasht University of Medical Sciences scientific Banafsheh ghavidel parsa
Sardare jangal avenue,Razi hospital
Rasht Iran (Islamic Republic of) 4144895655 +98 13 3353 0169 bghavidelparsa@gmail.com Rasht University of Medical Sciences Iran (Islamic Republic of) Patients must meet the American College of Rheumatology criteria for fibromyalgia (ACR2010). A rheumatologist confirms diagnosis of fibromyalgia. 18 years 70 years Both Age younger than 18 or older than 70 years old Pregnancy. Cases of chronic liver disease, severe renal failure Breast feeding History of sensitivity to B1 vitamin. History of sensitivity to B6 vitamin History of sensitivity to B12 vitamin Consumption of group B Vitamin supplements Fibromyalg M79.7 Treatment - Drugs Placebo Intervention group: The first group includes patients with fibromyalgia who receive 100 mg of vitamin B1, 100 mg of vitamin B6 and 200 micrograms of vitamin B12 as a single tablet made by Mahban Daru company, one per day for thirty days. Control group: This group includes patients suffering from fibromyalgia who receive the placebo manufactured by Subhan Daru company, which contains tablets of the same color, shape and size as the vitamin tablets received by the intervention group for one month and in the amount of one per day Disease severity. Timepoint: Before starting the study, then one month after taking medication. Method of measurement: revised fibromyalgia impact questionnaire. Pain intensity. Timepoint: Before starting the study, then one month after taking medication. Method of measurement: visual analogue scale. Quality of life. Timepoint: Before starting the study, then one month after taking medication. Method of measurement: 12item short form health survey. Rasht University of Medical Sciences Approved 2023-09-11 Ethics committee of Gilan University of medical sciences In front of 17 Shahrivar hospital, Shahid siadati street, Namjoo avenue Rasht Guilan Iran (Islamic Republic of)