Preprint / Version 1

Efficacy of ‘Itrifal Saghir’, a combination of three medicinal plants in the treatment of obesity; A randomized controlled trial

Authors

  • Seyed Kamali Student of Department Iranian Traditional Medicine, Faculty of Medicine, Shahed University, Tehran, Iran
  • Ali Khalaj Department of surgery, Mostafa Khomeyni Hospital, Shahed University, No 17. Clinic Salamat, Iranian Traditional Medicine Group, Dashtestan 3rd St., Pasdaran Ave, 1947948613, Tehran, Iran
  • Shirin Hasani-Ranjbar Endocrinology and Metabolism Research Institute, and Faculty of Medicine, Tehran University of Medical Sciences, 5th floor, Shariati Hospital, North Kargar Ave., Tehran, Iran
  • Mohammad Esfehani School of Traditional Medicines, Tehran University of Medical Sciences, Tehran, Iran
  • Mohammad Kamalinejad Department of Pharmacognosy, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran
  • Omidmalayeri Soheil Khatam Hospital, Tehran, Iran
  • Seyed Kamali Khatam Hospital, Tehran, Iran

Keywords:

Obesity, Itrifal Saghir, Traditional Iranian medicine, Randomized trial, Terminalia chebula, Terminalia bellerica, Emblica officinalis, Triphala

Abstract

Herbal combination of Itrifal Saghir (triphala) has been widely used in traditional medicine. And brings health benefits such as antioxidant effect and scavenger of hydroxyl radicals and nitric oxide radicals activity and substantiated in traditional medicine a anti-obesity. Material and method In this study we aimed to assess the efficacy of this herbal medicinal on reduction of weight and body mass index (BMI) of simple obese subjects in comparison with placebo. Obese subjects aged between 16 and 60 years were selected for 12-week, double-blind, randomized, placebo-controlled trial using a parallel design. Subjects were randomly assigned to take 5 grams of either the Itrifal Saghir (n = 31) or placebo (n = 31), 2 times daily for 12 weeks. Measures of body weight, BMI, waist circumference (WC), hip circumference (HC), were assessed at baseline and once every four weeks during the 12 week treatment period. The safety was evaluated by means of measuring the liver and kidney function. Homeostasis model of insulin resistance (HOMA-IR) was calculated as [fasting insulin (μU/mL) × fasting glucose (mmol/L)/22.5]. Results Compared to placebo group, in treatment group the mean difference of effective weight loss was 4.82Kg (CI95% 3.52 - 6.11, ρ < 0.001), the mean of decrease in waist circumference was 4.01 cm (CI 95% 2.13 - 5.90, ρ < 0.001), and the mean decrease in hip circumference was 3. 21 cm (CI 95% 1.96 - 4.45, ρ < 0.001) in treated subjects. No adverse effects or significant changes in liver and kidney function tests were observed in both placebo and treated groups. Conclusions Itrifal Saghir appears to produce a positive effect on weight loss in obese subjects. Keywords: Obesity, Itrifal Saghir, Traditional Iranian medicine, Randomized trial, Terminalia chebula, Terminalia bellerica, Emblica officinalis, Triphala

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