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IRCT20221022056262N1 IRCT 2022-12-09 Babol University of Medical Sciences Pistacia atlantica Oleoresin of preparation on weight loss 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 2023-01-21 anticipated 60 Complete https://irct.ir/trial/66689 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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, Blinding description: 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. 3 overweight and obesity. Intervention 1: Intervention group: Daily consumption of two 500 mg capsules of Pistacia Atlantica Oleoresin, half an hour after breakfast and dinner for 8 weeks. Pistacia Atlantica Oleoresin capsules are prepared by a pharmacy specialist in the traditional pharmacy laboratory of the Faculty of Traditional Medicine of Babol University of Medical Sciences. Intervention 2: Control group: Daily consumption of two placebo capsules containing 500 mg of starch, half an hour after breakfast and dinner for 8 weeks. The placebo capsule is prepared by a pharmacy specialist in the traditional pharmacy laboratory of the Faculty of Traditional Medicine of Babol University of Medical Sciences. 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 Based on the request and review in the institution, a decision will be made in each case of the request to share the data.
public Saeid Mohseni
Ganj Afrooz St
Babol Iran (Islamic Republic of) 4717647745 +98 11 3225 0824 saeidmohseny12463@gmail.com Babol University of Medical Sciences scientific saeid mohseni
School of Traditional, Babol University of Medical Sciences, Gang Afrooz St
Babol Iran (Islamic Republic of) 4717647745 +98 11 3219 9592 saeidmohseny12463@gmail.com Babol University of Medical Sciences Iran (Islamic Republic of) Women with mild to moderate initial overweight and obesity(BMI 25-39.9) 18 years 60 years Female E66.9 Obesity, unspecified Treatment - Drugs Placebo Intervention group: Daily consumption of two 500 mg capsules of Pistacia Atlantica Oleoresin, half an hour after breakfast and dinner for 8 weeks. Pistacia Atlantica Oleoresin capsules are prepared by a pharmacy specialist in the traditional pharmacy laboratory of the Faculty of Traditional Medicine of Babol University of Medical Sciences. Control group: Daily consumption of two placebo capsules containing 500 mg of starch, half an hour after breakfast and dinner for 8 weeks. The placebo capsule is prepared by a pharmacy specialist in the traditional pharmacy laboratory of the Faculty of Traditional Medicine of Babol University of Medical Sciences. The amount of weight change (body mass index) in overweight and obese women. Timepoint: Measurement of body mass index before the intervention, 30, 60, and 90 days after the start of the intervention. Method of measurement: Digital weighing machine. Measurement of the size of the abdomen. Timepoint: At the beginning of the study (before the start of the intervention), 30, 60, and 90 days after the start of intervention. Method of measurement: Measuring meter. Blood cholesterol, triglycerides, LDL and HDL levels. Timepoint: At the beginning of the study (before the start of the intervention) and 60 days after the start of the intervention. Method of measurement: blood test. Measure the size of the hip circumference. Timepoint: At the beginning of the study (before the start of the intervention), 30, 60, and 90 days after the start of intervention. Method of measurement: Measuring meter. Measurement of the ratio of the size of the abdominal circumference to the size of the hip circumference. Timepoint: At the beginning of the study (before the start of the intervention), 30, 60, and 90 days after the start of intervention. Method of measurement: Measuring meter. Babol University of Medical Sciences Approved 2022-10-17 Research Ethics Committee of Babol University of Medical Sciences Ganj Afrooz St Babol Mazandaran Iran (Islamic Republic of)