An open labelled single centric prospective clinical trial for evaluating the therapeutic efficacy of a Siddha regimen in the management of Athithoolam Atitula noy obesity Class I and II
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- A 5 to 10 percent reduction in BMI and a reduction in anthropometric measurements from
研究概览
简要总结
This open-labelled, single-centric, prospective clinical trial aims to evaluate the therapeutic efficacy of a Siddha regimen (Karunjeeraga Chooranam, Kukil parpam tablet, Naththaichoori chooranam) at Ayothidoss Pandithar Hospital Chennai, in managing Class 1 and 2 obesity. Participants aged between 18 and 60 years with a BMI greater than or equal to 30 kg/m², who meet the specified inclusion and exclusion criteria, will be enrolled in the trial. They will receive the trial regimen for an initial period of 48 days, followed by a 7-day drug-free interval, and then continue the regimen for an additional 48 days. The primary objective is to achieve a 5-10% reduction in BMI and anthropometric measurements, while secondary objectives include assessing changes in laboratory parameters and quality of life. The study excludes vulnerable groups, hypothyroidism, and malignancy, aiming to provide evidence on the efficacy of Siddha medicine in obesity management.
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
- •K/C/O Diabetes Mellitus Obesity – BMI greater than or equal to 30 kg/m^2 Obesity class I – BMI 30 to 34.9 kg/m^2 Obesity class II – BMI 35 to 39.9 kg/m^2.
排除标准
- •Vulnerable groups (Pregnancy and lactation) Hypothyroidism Malignancy The patient is not willing to undergo laboratory investigations.
结局指标
主要结局
A 5 to 10 percent reduction in BMI and a reduction in anthropometric measurements from
时间窗: 103 days
baseline to endpoint
时间窗: 103 days
次要结局
- To assess the difference in laboratory parameters and Enhanced Quality of Life from(baseline to endpoint)
