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IRCT20191125045496N2 IRCT 2021-01-16 Mazandaran University of Medical Sciences Evaluation of the Effect of Aerobic Exercise and Saffron Consumption in Fibromyalgia Patients A Comparison of Effect of Aerobic Exercise with Saffron Pills on CRP levels and Quality of Life in Fibromyalgia Patients 2019-04-04 anticipated 48 Complete https://irct.ir/trial/53596 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Factorial, Purpose: Health service research, Randomization description: A simple random method was used to determine the sample of each group. First, the names of all patients who entered the study were obtained, assigned to each of the numerical patients, and then a lottery was conducted between them. 3 Fibromyalgia. Intervention 1: Intervention group1: Aerobic exercise-placebo group:Aerobic exercise for six weeks (three sessions per week) consisted of 60-70% of maximal heart rate training for 24 to 39 minutes, under the control of a physician.In addition to training, the group took a placebo capsule (30 mg of starch) prepared by Green Plants Company once a day for 6 weeks according to the doctor's instructions. Intervention 2: Intervention group: Drug Intervention Group:In this group of safrotin capsules containing standardized dry extract of saffron, made by Green Plants Company, 30 mg once a day was prescribed according to the doctor's instructions for 6 weeks. Intervention 3: Intervention group: Drug-exercise group (Combined):In addition to aerobic exercise for six weeks (three sessions per week), this group includes exercise with an intensity of 60 to 70% of maximum heart rate for 24 to 39 minutes per session, from Safrotin capsule containing standardized dry extract of saffron, made by Green Plants Company ,Received 30 mg once daily during the intervention as directed by the treating physician. Intervention 4: Control group: Control group: This group took a placebo capsule (30 mg of starch) prepared by Green Plants Company once a day for 6 weeks according to the doctor's instructions. 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 Undecided - It is not yet known if there will be a plan to make this available
public Seyed Hamzeh Hosseini
mam Khomeini Hospital., Amir Mazandaran St., Sari Town
Sari Iran (Islamic Republic of) 4817875816 +98 11 3310 9231 hosseinish20@gmail.com Mazandaran University of Medical Sciences scientific Mostafa Behzad Khamslo
No. 3, Mahyar St., Maulam Blvd., Sari Town
Sari Iran (Islamic Republic of) 4817875816 +98 11 3310 9230 mostafabehzadkh@yahoo.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) Being infected to Fibromyalgia Lack of Metabolic Diseases, Menopause Do not consume energetic substances such as: Vitamins, Dietary Supplements, Herbs 25 years 50 years Female Consumption Cigarettes and Alcoholic beverages Having Regular Exercise Consumption history Antidepressants H35.17 fibromyalgia Treatment - Other Treatment - Other Treatment - Other Placebo Intervention group1: Aerobic exercise-placebo group:Aerobic exercise for six weeks (three sessions per week) consisted of 60-70% of maximal heart rate training for 24 to 39 minutes, under the control of a physician.In addition to training, the group took a placebo capsule (30 mg of starch) prepared by Green Plants Company once a day for 6 weeks according to the doctor's instructions. Intervention group: Drug Intervention Group:In this group of safrotin capsules containing standardized dry extract of saffron, made by Green Plants Company, 30 mg once a day was prescribed according to the doctor's instructions for 6 weeks. Intervention group: Drug-exercise group (Combined):In addition to aerobic exercise for six weeks (three sessions per week), this group includes exercise with an intensity of 60 to 70% of maximum heart rate for 24 to 39 minutes per session, from Safrotin capsule containing standardized dry extract of saffron, made by Green Plants Company ,Received 30 mg once daily during the intervention as directed by the treating physician. Control group: Control group: This group took a placebo capsule (30 mg of starch) prepared by Green Plants Company once a day for 6 weeks according to the doctor's instructions. Quality of Life. Timepoint: At baseline (before intervention) and 6 weeks after intervention. Method of measurement: Short Form Quality of Life Questionnaire (SF-36). C-reactive-protein. Timepoint: At baseline (before intervention) and 6 weeks after intervention. Method of measurement: By Eliza's research kit. Mazandaran University of Medical Sciences Approved 2019-12-18 Ethics Committee of Mazandaran University of Medical Sciences No. 3, Mahyar St., Maulam Blvd., Sari Town Sari Mazandaran Iran (Islamic Republic of)