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IRCT2014043012438N8 IRCT 2014-05-20 Kashan University of Medical Sciences The effect of cumin pearl on treatment of obesity The effect of capsule contain cumin essential oil on weight and metabolic profiles of obese and overweight patients and its comparison with orlistat 2014-04-27 anticipated 87 Complete https://irct.ir/trial/12496 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be randomly assigned into three groups. A list of random numbers from 1 to 87 using a random number generator (https://stattrek.com/statistics/random-number-generator.aspx) will be generated, and then patients will be randomly assigned using numbers into three groups. At study baseline, after stratification for gender, pre-intervention body mass index and age, subjects were randomly assigned to three groups. Randomization will be done by the use of computer-generated random numbers, Blinding description: Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the Clinic, who is not involved in the trial and not aware of random sequences, will assign the participants to the numbered bottles of drugs. Placebo capsules contained microcrystalline cellulose and were packed in identical capsules with drugs, and coded by Barij Essence Pharmaceutical company to guarantee blinding. Patients and researcher will not know the type of intervention. After analyzing the data, pocket codes will be decoded. Participants and investigators/the assessors of the outcomes are unaware of the study groups. 3 Obesity and overweight. Intervention 1: Intervention group 1: Cumin essential oil capsule (Barij Essence pharmaceutical company, Kashan, Iran), orally, three times a day, for 8 weeks. Intervention 2: Intervention group 2: Orlistat capsule (Hoffmann-La Roche Co, Munich, Germany), orally, three times a day, for 8 weeks. Intervention 3: Placebo capsule (Barij Essence pharmaceutical company, Kashan, Iran), orally, three times a day, for 8 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 Undecided - It is not yet known if there will be a plan to make this available
public Dr Mohsen Taghizadeh
Ghotbe Ravandi Boulevard, Kashan
Kashan Iran (Islamic Republic of) 8715988141 +98 36 1555 0021 taghizadeh_m@kaums.ac.ir Kashan University of Medical Sciences scientific Dr Zatollah Asemi
Ghotbe Ravandi Boulevard, Kashan
Kashan Iran (Islamic Republic of) 8715988141 +98 36 1555 0021 asemi_z@kaums.ac.ir Kashan University of Medical Sciences Iran (Islamic Republic of) Overweight (Body mass index range: 25.2–48.8 kg/m 2) Aged 18–60 18 years 60 years Both Those with malignancy Metabolic disorders Thyroid disorders Cardiovascular disorders Pregnancy and lactation Those using hormonal, antidiabetic, or anti-obesity medications E66 Obesity Treatment - Drugs Treatment - Drugs Placebo Intervention group 1: Cumin essential oil capsule (Barij Essence pharmaceutical company, Kashan, Iran), orally, three times a day, for 8 weeks. Intervention group 2: Orlistat capsule (Hoffmann-La Roche Co, Munich, Germany), orally, three times a day, for 8 weeks. Placebo capsule (Barij Essence pharmaceutical company, Kashan, Iran), orally, three times a day, for 8 weeks. Weight change. Timepoint: Baseline and end of study. Method of measurement: Scale. Total cholesterol. Timepoint: Baseline and end of study. Method of measurement: Enzymatic kit. Insulin. Timepoint: Baseline and end of study. Method of measurement: ELISA kit. Triglycerides. Timepoint: Baseline and end of study. Method of measurement: Enzymatic kit. HDL-cholesterol. Timepoint: Baseline and end of study. Method of measurement: Enzymatic kit. LDL-cholesterol. Timepoint: Baseline and end of study. Method of measurement: Enzymatic kit. Glutathione. Timepoint: Baseline and end of study. Method of measurement: Spectrophotometry. Fasting plasma glucose. Timepoint: Baseline and end of study. Method of measurement: Enzymatic kit. Insulin resistance. Timepoint: Baseline and end of study. Method of measurement: Calculation using HOMA formula. Thyroid hormones. Timepoint: Baseline and end of study. Method of measurement: ELISA kit. Total antioxidant capacity. Timepoint: Baseline and end of study. Method of measurement: Spectrophotometry. Kashan University of Medical Sciences Approved 2014-04-26 Kashan University of Medical Sciences Ghotbe Ravandi Boulevard, Kashan Kashan Isfehan Iran (Islamic Republic of)