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一项评估草药配方HFO - 02对超重个体疗效的临床研究。

A clinical study to evaluate the efficacy of Herbal Formulation for Obesity (HFO-02) in overweight individuals.

作者信息

Gupte Poonam, Harke Shubhangi, Deo Veena, Bhushan Shrikhande Bharat, Mahajan Madhavi, Bhalerao Supriya

机构信息

Obesity-Diabetes Lab, Interactive Research School for Health Affairs, Bharati Vidyapeeth, Pune, 411043, India.

Research & Development Department, Siddhayu Ayurvedic Research Foundation Pvt Ltd, Nagpur, 440009, India.

出版信息

J Ayurveda Integr Med. 2020 Apr-Jun;11(2):159-162. doi: 10.1016/j.jaim.2019.05.003. Epub 2019 Aug 29.

DOI:10.1016/j.jaim.2019.05.003
PMID:31474325
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7329718/
Abstract

BACKGROUND

Ayurveda, the Indian system of medicine offers many herbs and formulations for management of obesity. Baidyanath Bhawan Pvt. Ltd has designed a formulation, HFO-02, based on Ayurvedic literature.

OBJECTIVE

To evaluate the efficacy of Herbal Formulation for Obesity (HFO-02) in overweight individuals.

MATERIALS & METHODS: With approval from the Institutional Ethics Committee, a proof of concept study was carried out in overweight individuals (Body Mass Index, BMI ≥25.0 and ≤ 30.0 kg/m), devoid of any endocrinological disorders. Tablet HFO-02 (500 mg) was administered to these individuals twice daily for 90 days, during which they were called at study site fortnightly. After stopping the treatment, they were further followed up for 30 days off-medication and the last follow up was scheduled on day 120. Anthropometric parameters were assessed at every visit, while biochemical parameters viz. lipid profile, blood sugar & insulin levels (both fasting and post prandial), C- reactive protein and adipocytokines (leptin & adiponectin) were estimated monthly.

RESULTS

Of the 18 participants recruited in the study; 14 completed the study. HFO-02 did not show reduction in weight, however a significant decrease in the body circumference and skin fold was demonstrated. This decrease was maintained till day 120. The levels of all biochemical parameters were maintained and no adverse events were reported throughout the study.

CONCLUSION

Tablet HFO-02 reduced body circumferences and skinfold thickness indicating its potential for obesity management.

CLINICAL TRIAL REGISTRATION NUMBER

CTRI/2016/07/007067.

摘要

背景

印度传统医学阿育吠陀提供了许多用于管理肥胖的草药和配方。拜迪雅纳斯大厦私人有限公司根据阿育吠陀文献设计了一种配方HFO - 02。

目的

评估肥胖草药配方(HFO - 02)对超重个体的疗效。

材料与方法

经机构伦理委员会批准,在超重个体(体重指数,BMI≥25.0且≤30.0kg/m²)中开展了一项概念验证研究,这些个体无任何内分泌疾病。给这些个体每日两次服用HFO - 02片剂(500mg),持续90天,在此期间每两周将他们召集到研究地点。停止治疗后,对他们进行30天的停药随访,最后一次随访安排在第120天。每次就诊时评估人体测量参数,同时每月估计生化参数,即血脂谱、血糖和胰岛素水平(空腹和餐后)、C反应蛋白和脂肪细胞因子(瘦素和脂联素)。

结果

在该研究招募的18名参与者中,14名完成了研究。HFO - 02未显示体重减轻,但身体周长和皮褶厚度有显著下降。这种下降一直维持到第120天。所有生化参数水平保持稳定,并且在整个研究过程中未报告不良事件。

结论

HFO - 02片剂减小了身体周长和皮褶厚度,表明其在肥胖管理方面的潜力。

临床试验注册号

CTRI/2016/07/007067。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bffc/7329718/d93b0ea4d5c3/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bffc/7329718/d93b0ea4d5c3/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bffc/7329718/d93b0ea4d5c3/gr1.jpg

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