A comparative clinical study of the efficacy of Triphaladi vidangadi lekhan basti and Vidangadi Ghana vati in the management of Sthoulya w.s.r. to obesity
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Waist circumference,
研究概览
简要总结
This study is a randomized open label parallel group trial comparing the efficacy of Lekhan basti (~medicated enema for obesity) which will be given in Kala basti manner for 15 days of Anuvasana basti(medicated oily enema) with Triphaladi taila (oil) and Saindhav lavan (rock salt) in the total dose of 120 ml and Asthapana basti with Triphala vidangadi kwath (decoction),Triphaladi oil,honey and Kalka(paste of medicinal drugs) in the total dose of 960 ml in one group of 15 patients and Vidangadi Ghan Vati in another group of 15 patients suffered from obesity. The trial will be conducted in National institute of Ayurveda Jaipur India with primary outcome of reduction in BMI, Hip circumference,waist circumference,mid thigh and mid arm circumference and skin fold thickness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Open Label
入排标准
- 年龄范围
- 16.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Age Between 16-70 years, suffering from Sthoulya (Obesity) irrespective of religion, sex, occupation etc.
- •2.Patients who fulfil the criteria for sthoulya & Obesity.
- •3.Patients who are fit for Lekhana Basti karma.
- •4.Patient who are not on any other medicine for Sthoulya Â.
排除标准
- •1.Patients with long term Steroid treatment.
- •2.Patients suffering from obesity due to hereditary indisposition.
- •3.Patients with severe Hypertension.
- •5.Patients with Diabetes mellitus.
- •7.Patients who are unfit for Lekhana Basti karma.
- •8.Patients who have any severe metabolic disorder.
结局指标
主要结局
Waist circumference,
时间窗: 2 months | Â
BMI,
时间窗: 2 months | Â
Hip circumference,
时间窗: 2 months | Â
Skin fold thickness
时间窗: 2 months | Â
Mid thigh circumference,
时间窗: 2 months | Â
Mid arm circumference.
时间窗: 2 months | Â
Â
时间窗: 2 months | Â
次要结局
- Quality of lifeÂ(2 month)