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IRCT20210510051241N1 IRCT 2021-05-25 Tehran University of Medical Sciences The effects of Bunium percicum capsule on obesity The effects of Bunium percicum capsule (a Persian medicine product) on anthropometric indices and biochemical factors in overweight and obese women. 2021-05-22 anticipated 64 Complete https://irct.ir/trial/56182 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: R4.0.2 software A randomized list was needed to randomly assign individuals. We used R software to prepare this list, which included 0 and 1. In this software, random samples were generated from a binomial distribution with P = 0.5 equal to the total number of samples (64 people). ((64,0.5) A = rbinom) A vector of these numbers consists of 64 randomly arranged numbers 0 and 1 for random actions of the drug or placebo group. The probability P = 0.5 leads to an equal chance of each person being in one of these groups. At the end, the numbers 1 and 0 are counted to match 32 people in each group, Blinding description: The shape of the medications and placebos will be perfectly the same. Therefore, patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. The analyzer will be unaware of the type of interventions. Thus, the trial will be run as triple blind. 2-3 Condition 1: Obesity. Condition 2: Overweight. Intervention 1: Intervention group: each volunteer will take 2000 mg daily (one capsule 30 minutes before breakfast, two capsules 30 minutes before lunch and, one capsule 30 minutes before dinner) drug for 8 weeks. All the participants will receive a diet designed by a nutritionist. Preparation of the herbal extracts is done by basic medical sciences research center "Histogenotech" and product packaging and filling of capsules are done by Tooba Company. Intervention 2: placebo group: each volunteer will take 2000 mg daily (one capsule 30 minutes before breakfast, two capsules 30 minutes before lunch and, one capsule 30 minutes before dinner) placebo for 8 weeks. All the participants will receive a diet designed by a nutritionist. Yes - There is a plan to make this available What will be shared: Participants' information including questionnaires and laboratory data can be provided if additional studies are needed. When: For 6 months from the end of the research To whom: Only researchers working in academic institutions Conditions: Having a research proposal that represents the implementation of another research project to complete the present study. Where to obtain: Zahra Aghabeiglooei How to obtain: Submit a request Review of requests by researchers Announcement of the result of the review Comments:
public Zahra Aghabeiglooei
School of Persian Medicine, Tehran University of Medical Sciences, SarParast St., Taleghani St., ValiAsr Blvd.
Tehran Iran (Islamic Republic of) 1449614353 +98 21 6697 6527 aghabeiglooei@gmail.com Tehran University of Medical Sciences scientific Zahra Aghabeiglooei
School of Persian Medicine, Tehran University of Medical Sciences, SarParast St., Taleghani St., ValiAsr Blvd.
Tehran Iran (Islamic Republic of) 1449614353 +98 21 6697 6527 aghabeiglooei@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Female only Age 20 to 40 years Women over the age of 40 will be included in the study if they have a normal mammogram. BMI between 25 and 34.9 kg / m2 20 years 50 years Female Pregnancy and lactation Menopause Hypermenorrhea, Menorrhagia Regular use of teas or other herbal medicines Smoking or alcohol consumption History of any types of malignancies Asthma History of any allergies History of any hormonal disorders History of chronic liver, heart, kidney, thyroid diseases, diabetes mellitus, hypertension, infectious diseases Family history of Brest or endometrial cancer in first-degree relatives Regular use of acetaminophen (paracetamol) or anticoagulants or antiplatelet drugs such as aspirin, warfarin, heparin and ... Use of weight loss diets or weight loss drugs during the last 6 months E66.9 5B80.0Z Obesity, unspecified Overweight or localised adiposity Treatment - Drugs Placebo Intervention group: each volunteer will take 2000 mg daily (one capsule 30 minutes before breakfast, two capsules 30 minutes before lunch and, one capsule 30 minutes before dinner) drug for 8 weeks. All the participants will receive a diet designed by a nutritionist. Preparation of the herbal extracts is done by basic medical sciences research center "Histogenotech" and product packaging and filling of capsules are done by Tooba Company. placebo group: each volunteer will take 2000 mg daily (one capsule 30 minutes before breakfast, two capsules 30 minutes before lunch and, one capsule 30 minutes before dinner) placebo for 8 weeks. All the participants will receive a diet designed by a nutritionist. Weight. Timepoint: At the beginning of the study (before the intervention), 4 weeks and 8 weeks after the intervention. Method of measurement: Digital scales. Waist circumference size. Timepoint: At the beginning of the study (before the intervention), 4 weeks and 8 weeks after the intervention. Method of measurement: Tape measure. Hip circumference size. Timepoint: At the beginning of the study (before the intervention), 4 weeks and 8 weeks after the intervention. Method of measurement: Tape measure. Body Mass Index (BMI). Timepoint: At the beginning of the study (before the intervention), 4 weeks and 8 weeks after the intervention. Method of measurement: Ratio of weight to height squared. The dietary intake. Timepoint: At the beginning of the study (before the intervention) and 8 weeks after the intervention. Method of measurement: Dietary intake questionnaire. Fasting blood glucose. Timepoint: At the beginning of the study (before the intervention) and 8 weeks after the intervention. Method of measurement: Laboratory measurement method auto analyzer. Serum Triglyceride. Timepoint: At the beginning of the study (before the intervention) and 8 weeks after the intervention. Method of measurement: Laboratory measurement method auto analyzer. Serum High Density Lipo protein(HDL). Timepoint: At the beginning of the study (before the intervention) and 8 weeks after the intervention. Method of measurement: Laboratory measurement method auto analyzer. Serum low density lipoprotein level. Timepoint: At the beginning of the study (before the intervention) and 8 weeks after the intervention. Method of measurement: Friedwalt formula. Serum Cholestrole. Timepoint: At the beginning of the study (before the intervention) and 8 weeks after the intervention. Method of measurement: Laboratory measurement method auto analyzer. Alanine transaminase. Timepoint: At the beginning of the study (before the intervention) and 8 weeks after the intervention. Method of measurement: Laboratory measurement method auto analyzer. Aspartate aminotransferase. Timepoint: At the beginning of the study (before the intervention) and 8 weeks after the intervention. Method of measurement: Laboratory measurement method auto analyzer. Tehran University of Medical Sciences Approved 2021-05-08 School of Medicine- Tehran University of Medical Sciences (Biomedical Research Ethics Committee) 1th Floor, Medicine School, Poursina St, Qods St, Enghelab St. Tehran Tehran Iran (Islamic Republic of)