A Randomised Comparative Clinical Trial To Evaluate The Effect Of Tara Mandura Guda And Navaka Guggulu In The Management Of Sthoulya w.s.r To Obesity
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Effect of Trial drug on improvement in classical symptoms of Sthoulya (Obesity)
研究概览
简要总结
Obesity is the prime factor in initiating the diseases like dyslipidemia, DM, HTN, CAD and menstrual irregularities due to drastic change in lifestyle and dietary habit. According to WHO a BMI over 25 is overweight and over 30 as obese, 4 million people die each year as a result of obesity, WHO has undertaken obesity in 10 selected risks to the health on world heath report 2002. India is 3rd most obese country in the world. By 2030 one in five women and one in seven men will have obesity.
Classical ayurveda texts have explained Asta-Nindita Purushas among which Sthoulya is one and a Santarpanajanya Vyadhi which can be compared to obesity in contemporary science having cardinal features like, Chala-Sphik-Udara-Stana, Sweda Adhikya, Daurbalya etc. Hence attempt is made to evaluate the effect of Tara Mandura Guda and Navaka Guggulu in the management of Sthoulya.
Tara Mandura Guda is mentioned in Bhaishyajya ratnavali 30th chapter.
It is a Randomized Controlled Clinical Trial 40 patients of Sthoulya will be selected incidentally and randomly assigned into two groups; Group ‘A’ and ‘B’ by software generated chart.
Group Aand Group B patients will be given Tara Mandura Guda and Navaka Guggulu respectively subjects will be assessed on the basis of BMI, weight, Anthropometry, Skin fold thickness with classical signs and symptoms.
Total study duration will be 60 days containing 4 visits (0th day, 15th day, 30th day, 60th day) which includes administration of trial drug for 30 days and post medicine follow up on 60th day. After study, data will be collected from Case report Form (CRF) and statistically analysed by using appropriate parametric and non-parametric tests and results will be obtained.
On the basis of results, conclusion will be drawn.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient having classical signs and symptoms of Sthoulya.
- •Patient with BMI above 25 and below
- •Both fresh and treated cases, who are not on medication for obesity atleast for 1 month.
- •Subjects willing to sign consent.
排除标准
- •Pregnant and Lactating women’s.
- •Diagnosed cases of PCOD, Hypothyroidism, Diabetes mellitus and Hypertension who are on medications.
- •Any other conditions where researcher may feel it may intervein the study.
- •Patients under on going concomitant medications which may intervein the study.
结局指标
主要结局
Effect of Trial drug on improvement in classical symptoms of Sthoulya (Obesity)
时间窗: 15day, 30day, 60day
次要结局
- Safety of the trial drug and adverse drug reaction and aggravation in the symptoms of Sthoulya (Obesity)(15day, 30day, 60day)
研究者
Dr Vidya Maishale
Sidramappa Danigond Memorial Trusts Ayurvedic Medical College Post Graduation Centre