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IRCT201706107265N9 IRCT 2017-06-24 Vice chancellor for research, Mashhad University of Medical Sciences The effect of acupuncture, hypericum perforatum and diet in appetite and weight control Comparison of integrative medicine (acupuncture, Hypericum perforatum and life style modification) with life style modification in appetite and weight control 2017-10-23 anticipated 88 Complete https://irct.ir/trial/7704 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization will be done using SPSS version 16 by selecting quadrants blocks, Blinding description: Participants, the nutritionist, the outcome assessor, and the statistician will be blinded from the identity of the study groups. The acupuncturist will not be blinded. The participant blindness will be performed using sham acupuncture and placebo. 3 obesity. Intervention 1: Intervention group 1: acupuncture, 3 times per week + 4 tablets of 160 mg Perforan (Goldaru company) + life style modification for 6 weeks. Intervention 2: Intervention group 2: acupuncture 3 times/week + placebo tablets+ life style modification for 6 weeks. Intervention 3: Intervention group 3: sham acupuncture, 3 times/week+ 4 tablets of 160 mg Perforan (Goldaru company) + life style modification for 6 weeks. Intervention 4: Control group: sham acupuncture, 3 times/week + placebo + life style modification for 6 weeks. 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 Dr. Monirsadat Sahebkar Khorasani
Pardis daneshgah, Park Square
Mashhad Iran (Islamic Republic of) 9177948564 +98 51 3882 9279 sahebkarm931@mums.ac.ir School of Traditional and Complementary Medicine scientific Dr. Hoda Azizi
Azadi Square
Mashhad Iran (Islamic Republic of) 9177948564 +98 51 3882 9279 azizih@mums.ac.ir School of Traditional and Complementary Medicine, Mashhad University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Appetite score more than 5 according to visual analogue scale Body mass index between 24.9 to 39.9 Women 18 years old to pre-menopause; men 18 to 60 years old Failure to life style modification alone "Liver qi stagnation" syndrome according to Chinese Medicine syndrome differentiation 18 years 60 years Both Hypothyroidism, Cushing's syndrome, cancer, liver or kidney failure Using drugs effective on appetite, weight and metabolism in the previous month Using drugs that interfere with Hypericum perforatum such as protease inhibitors, amiodarone, anticoagulants, cyclophosphamide, cyclosporine, monoamine oxidase inhibitors, phenytoin, tacrolimus, tamoxifen and trazodone drug Drug abuse or alcoholism Breast-feeding, pregnancy or planning a pregnancy during the next two months Having pacemaker or any other metal device inside the body due to the use of electroacupuncture and Bioelectrical Impedance Analyzer disability to do recommended physical activity Allergy to Hypericum perforatum or metal Coagulation disorders History of receiving acupuncture E66.0 Obesity due to excess calories Other Other Other Lifestyle Intervention group 1: acupuncture, 3 times per week + 4 tablets of 160 mg Perforan (Goldaru company) + life style modification for 6 weeks Intervention group 2: acupuncture 3 times/week + placebo tablets+ life style modification for 6 weeks Intervention group 3: sham acupuncture, 3 times/week+ 4 tablets of 160 mg Perforan (Goldaru company) + life style modification for 6 weeks Control group: sham acupuncture, 3 times/week + placebo + life style modification for 6 weeks Plasma nesfatin-1. Timepoint: Before intervention, Sixth week. Method of measurement: Laboratory: ELISA. Appetite score. Timepoint: Before intervention, weeks 2, 4, 6, 24. Method of measurement: Visual Analogue Scale. Body Mass Index. Timepoint: Before intervention, weeks 2, 6, 24. Method of measurement: Using the bioelectrical impedance analyzer; kg/m2. Waist circumference. Timepoint: Before intervention, weeks 2, 6, 24. Method of measurement: Using a tape measure; centimeters. Hip circumference. Timepoint: Before intervention, weeks 2, 6, 24. Method of measurement: Using a tape measure; centimeters. Body composition. Timepoint: Before intervention, weeks 2, 6. Method of measurement: Using the bioelectrical impedance analyzer. Lipid profile. Timepoint: Before intervention, week 6. Method of measurement: Laboratory. Liver enzymes. Timepoint: Before intervention, week 6. Method of measurement: Laboratory. Blood glucose level. Timepoint: Before intervention, week 6. Method of measurement: Laboratory. Adverse events. Timepoint: During the study period within 48 to 72 hours of incidence; week 6. Method of measurement: Study checklist. Vice chancellor for research, Mashhad University of Medical Sciences Approved 2017-06-06 Ethics Committee of Mashhad University of Medical Sciences Qorashi building, Daneshgah Street Mashhad Razavi Khorasan Iran (Islamic Republic of)