CTRI/2016/07/007067已完成不适用
Clinical study to evaluate the safety and efficacy of Herbal formulation for Obesity [HFO-O2] in overweight individuals
Baidyanath Bhavan Pvt Ltd1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2016年6月2日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- The outcome of the study will be measured in terms of anthropometric measurements (Weight, Body Mass Index, Waist Hip Ratio, Circumferences, Skinfold thicknesses)and Clinical signs and symptoms.
研究概览
简要总结
The primary purpose of the study is to evaluate the clinical efficacy of Tab. HFO-O2 in overweight individuals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Overweight individuals (Body Mass Index between 25-30) with controlled co-morbid dyslipidemia and/or hypertension and/or type 1 or type 2 diabetes 2.Stable body weight (less than 5 kg self-reported change during the previous 3 months) 3.Age between 18 years and 60 years 4.Individuals found compliant based on the Million Behavioural Medicine Diagnostic (MBMD) 5.Willing to give Informed consent before any trial-related activity takes place.
排除标准
- •1.Known case of endocrinological disorders such as hyper/hypo thyroidism, Poly Cystic Ovarian Syndrome (PCOS) 2.History of use one month before screening /currently using Allopathic or Ayurvedic medicines that may cause significant weight gain 3.History of use one month before screening /currently using dietary supplements, over-the-counter medications or below mentioned Allopathic /Ayurvedic medicines for weight loss 4.Current participation (past one month) in an organized weight reduction program   5.Participants with a history of major depressive or other severe psychiatric disorders or an eating disorder [judged by frequency and quantity of food] 6.Surgery scheduled for the trial duration period, except for minor surgical procedures, at the discretion of the investigator 7.Pregnant or lactating females.
结局指标
主要结局
The outcome of the study will be measured in terms of anthropometric measurements (Weight, Body Mass Index, Waist Hip Ratio, Circumferences, Skinfold thicknesses)and Clinical signs and symptoms.
时间窗: After every 15 days
次要结局
- The secondary outcome of the study will be measured on the basis of biochemical profiling of obesity markers.(Day 0,Day 30,Day 60,Day 90, Day 120)
研究者
研究点 (1)
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