The effects of Bunium percicum capsule (a Persian medicine product) on anthropometric indices and biochemical factors in overweight and obese women.

Evaluating the effects of Bunium percicum capsule on anthropometric and biochemical indices in overweight and obese women

three-blind randomized controlled clinical trial. randomization with the R4.0.2 software. sample size=64 (32 patients in each group).

The location of the project will be Ahmadieh Health Center affiliated with the Faculty of Persian Medicine of Tehran University of Medical Sciences. Capsules containing the drug and placebo will be exactly the same in shape, color and size and will be stored in dark bottles. The bottles will be named A and B, and researchers, volunteers, outcome assessors, and statistical data analysts will not know which group of drugs and which placebo.

Inclusion criteria: Women Age 20-40 Women older than 40 will be included if they have a normal mammogram. BMI 25 -34.9 kg / m2 Non-inclusion criteria: Pregnancy, lactation Menopause Hypermenorrhea Regular use of teas or other herbal medicines Smoking,alcohol consumption History of any types of malignancies Asthma Allergies Hormonal disorders The 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 Use of weight-loss diets or weight loss drugs during the last 6 months

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 or placebo for 8 weeks. All participants in both groups will receive a diet designed by a nutritionist.

Weight, BMI, Waist size, Hip size, Waist to hip ratio Food intake Fasting Blood Sugar, Blood lipid profile

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.

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.

Participants' information including questionnaires and laboratory data can be provided if additional studies are needed.

For 6 months from the end of the research

Only researchers working in academic institutions

Having a research proposal that represents the implementation of another research project to complete the present study.

Zahra Aghabeiglooei

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