Randomise Controlled Clinical Trial to Compare Krimighnadi Ghanwati & Mustadikwath Ghanwati in Management of Sthoulya (obesity)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Improvement in Sign & Symptoms of Sthoulya Parameters like Atikshudha,Atinidra,Atisweda,Swedadurgandhi,Alasya,Shramshwasa,Atipipasa,Angasad,Alpamaithun,Udarayam(cm),Sphikayam(cm),Stanaayam(cm),Reduction in Weight,BMI,Skinfold thickness,CBC,Urine Routine & Microscopic,BSL Fasting
研究概览
简要总结
An open label, Randomise Controlled Clinical Trial to Compare Krimighnadi Ghanwati & Mustadikwath Ghanwati in Management of Sthoulya (obesity),total 102 patient fulfilling the clinical criteria of sthoulya between age group 16 to 60 will be selected from kaychikitsa department and alloted randomly in 2 groups,drugs will be given as 500mg tablet after lunch and dinner ,pathya apathya will be advised to the patient during trial,duration of trial will be of 90 days ,treatment start day -0 follow up on 30,60,90days patient will be reviewed on 120th day
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 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients having signs and symptoms of Sthoulya explained in Ayurvedic Texts 2.Patients from age group 16-60 years 3.Patients of both genders.
- •4.Patients having BMI equal or more than 25.
排除标准
- •1.Drug induced obesity 2.Obesity due to certain secondary causes 3.Hormonal disorders 4.Pregnant women 5.Disease associated obesity patient.
- •6.BMI less than 25.
结局指标
主要结局
Improvement in Sign & Symptoms of Sthoulya Parameters like Atikshudha,Atinidra,Atisweda,Swedadurgandhi,Alasya,Shramshwasa,Atipipasa,Angasad,Alpamaithun,Udarayam(cm),Sphikayam(cm),Stanaayam(cm),Reduction in Weight,BMI,Skinfold thickness,CBC,Urine Routine & Microscopic,BSL Fasting
时间窗: 0,30,60 ,90 And 120 Days
次要结局
- Reduction in BMI level, lipid profile, anthropometry.(0 ,30 ,60and 90 days)