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IRCT20090609002017N37 IRCT 2023-06-14 Tabriz University of Medical Sciences The effects of slimming topical gel on overweight and obese women The effects of slimming topical gel on anthropometric indices and body composition and biochemical factors in overweight and obese women: A double blind randomized controlled trial 2023-06-22 anticipated 30 Complete https://irct.ir/trial/70625 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Other, Randomization description: participants randomly using random block method and RAS (Random Allocation Software) and allocation ratio 1:1:1 and after equalization based on body mass index into 3 groups of 10 people 1) topical use of gel Slimming for the entire abdominal circumference 2) Using slimming gel for half the abdominal circumference 3) Using Oserin as a placebo for the abdominal circumference for 8 weeks, Blinding description: For all three study groups, the topical gel used will be the same in terms of shape, color and dosage. Participants, the principal investigator, health care personnel, those evaluating the outcome, the Data Safety and Monitoring Committee, and those drafting the article will be blinded. 1-2 obesity and overweight. Intervention 1: Intervention group: The intervention group will apply the topical jell every day for 8 weeks. The instruction to use the ointment will be applying 1 cc to the whole abdominal area except around the belly button (i.e., 10 cm2) and to cover the area with a plastic sheet. Intervention 2: Intervention group: The intervention group will apply the topical jell every day for 8 weeks. The instruction to use the ointment will be applying 1 cc to the half of the abdominal area except around the belly button (i.e., 10 cm2) and to cover the area with a plastic sheet. Intervention 3: placebo group: The placebo group will apply the topical oserin every day for 8 weeks. The instruction to use the ointment will be applying 1 cc to the half of the abdominal area except around the belly button (i.e., 10 cm2) and to cover the area with a plastic sheet. Yes - There is a plan to make this available What will be shared: Data collected for the primary outcomes will be shared. When: Data will be available 12 months after manuscript publication To whom: The data will only be available for people working in academic institutions. Conditions: The data of the present study will only be accessible by other researchers, for conducting Meta-analysis. Where to obtain: The researchers (student and her supervisor) How to obtain: Request a document via email Comments:
public Dr. Alireza Ostadrahimi
Nutrition Faculty, Attar Neyshabouri Avenue, Golgasht Street
Tabriz Iran (Islamic Republic of) 5166614711 +98 41 3335 2292 ostadrahimi@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Dr. Alireza Ostadrahimi
Nutrition Faculty, Attar Neyshabouri Avenue, Golgasht Street
Tabriz Iran (Islamic Republic of) 5166614711 +98 41 3335 2292 ostadrahimi@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) 19-65 years old body mass index above30 or above 27 with one or two risk factors like hypertension and type 2 diabetes 19 years 65 years Female consumption of weight loss drugs and supplements three months before the intervention Hypothyroidism heart disease Taking high-dose oral corticosteroids Pregnant and lactating women Smoking and alcohol consumption E66 Overweight and obesity Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group: The intervention group will apply the topical jell every day for 8 weeks. The instruction to use the ointment will be applying 1 cc to the whole abdominal area except around the belly button (i.e., 10 cm2) and to cover the area with a plastic sheet. Intervention group: The intervention group will apply the topical jell every day for 8 weeks. The instruction to use the ointment will be applying 1 cc to the half of the abdominal area except around the belly button (i.e., 10 cm2) and to cover the area with a plastic sheet. placebo group: The placebo group will apply the topical oserin every day for 8 weeks. The instruction to use the ointment will be applying 1 cc to the half of the abdominal area except around the belly button (i.e., 10 cm2) and to cover the area with a plastic sheet. Antropometric indices (Weight, Height, BMI, Waist circumference, Hip circumference, Waist to Hip Ratio). Timepoint: Baseline and at the end of intervention. Method of measurement: Physical exam. Body composition. Timepoint: baseline and after intervention. Method of measurement: tanita body composition analysis device. Liver enzymes, BUN and creatinine. Timepoint: baseline and after intervention. Method of measurement: biochemical methods. Appetite. Timepoint: baseline and after intervention. Method of measurement: visual analog scale appetite. Tabriz University of Medical Sciences Approved 2023-05-08 Ethics committee of Tabriz University of Medical Sciences Vice Chancellor for Research and Technology,Golgasht St tabriz East Azarbaijan Iran (Islamic Republic of)