Evaluation of the effect of Pistacia Atlantica Oleoresin of preparation on weight loss in women 18-60 years old with overweight and obesity (BMI≥25), Double-blind randomized controlled clinical trial

Evaluation of the effect of Pistacia atlantica Oleoresin of preparation on weight loss in women 18-60 years old with overweight and obesity (BMI≥25)

َA controlled, parallel-group, double-blind, randomized clinical trial on random selection of 60 women (aged 18-60 years/BMI over 25) referred to traditional clinic of Babol university of medical sciences after obtaining Informed consent and completing the temperament questionnaire and measuring the weight and size of the waist and hip circumference (in fasting/beginning of the day) and performing lipid profile tests after eight hours of fasting Randomly placed in two groups (drug and placebo) based on 'quadruple blocking' to use one of the medicinal forms

At first, 4 and 8 weeks after the start of treatment, the weight and size of the waist and hip circumference and their ratio in clinic of Traditional Medicine, Babol University of Medical Sciences are evaluated, and the blood lipid tests are re-checked after 8 weeks from the start of the treatment. Also, 4 weeks after the end of the treatment, weight and size around the waist and hips will be evaluated.

Eligibility Criteria: Patients with mild to moderate overweight and obesity (BMI between 25-39.9) Age18-60 years Exit criteria: people with a history of diabetes; cardiovascular diseases; Hepatic and renal and patients with hyperlipidemia in need of drug treatment Pregnancy and breastfeeding

Intervention group: 500 mg mastic capsules two times a day (8 weeks) Control group: 500 mg starch capsules two times a day (8 weeks) People in both groups will be evaluated at the beginning of the study, at weeks 4, 8, and 12, for changes in weight, waist and hip circumference, and fat profile.

Weight, waist size, hip size, triglyceride and cholesterol levels, LDL and HDL in the blood

Randomization and concealment of the treatment process: Randomization is done using the method of random permutation blocks. The size of the blocks is 4 and the ratio of two groups in each block is considered equal (1:1). Medicines in two categories (drug and placebo) are prepared by the study pharmacist and sent to the study statistician. The random sequence is generated by the website https://www.sealedenvelope.com. In order to hide the treatment process, a three-digit code is considered for each drug/placebo, and three-digit codes are written on the cans containing the drug/placebo. Coding will be done by a statistician.

Placebo will be prepared in the form of capsules completely similar to turpentine capsules (in terms of color, smell, and taste). In addition, all the capsules are placed in completely identical cans and will be provided to the study participants. Therefore, both the participants nor the evaluators of the plan are not aware of the type of treatment, so this study is double-blind. In order to match the smell, the placebo capsules are placed for some time in a space adjacent to the turpentine essential oil.

Potential sharing of all data is possible after the de-identification of individuals and upon registration of a request and approval by the institution.

Access to information and data 6 months after the publication of the article is available

The data will be available to researchers working in academic and scientific institutions, or people who are also engaged in the industry can apply to receive them.

Having an approved proposal approved by academic institutions and also having an ethics code is mandatory to review the application.

Correspondence with the e-mail of the executive in charge of the project

-Send the application along with documents (proposal and code of ethics) to saeidmohseny12463@gmail.com -check the request by the responsible executive and its proposal in the research council of the traditional medicine research center Answer to the request (Estimated duration of review of each request is about one month)