Prospective single arm open clinical trial to evaluate the efficacy of Punarnavadi Vati in the management of Sthaulya with special reference to Dyslipidemia in Hypertension.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- to evaluate the efficacy of Punarnavadi Vati In Sthaulya with special reference to Dyslipidemia in Hypertension.
研究概览
简要总结
single arm open clinical trial
this study is conducting for To evaluate the efficacy of Punarnavadi Vati In Sthaulya with special reference to Dyslipidemia in Hypertension.
Total 30 patients of Sthaulya with hypertension who fulfils inclusion criteria and showing signs and symptoms will Be taken from OPD and IPD of concerned institute. Written information consent will be taken in native language.
Various epidemiological studies have shown the prevalence of the co-existence of dyslipidemia with hypertension in the range of 15 to 31% and Prevalence in Maharashtra is 34%. As per modern science sthaulya sings and symotoms resembles with dyslipidemia, It is characterised by abnormal level of lipids.
Null Hypothesis
Punarnavadi vati 500mg orally four tablets twice a day for 30 days is not effective in sthaulya with special reference to Dyslipidemia in HTN
Alternative Hypothesis
Punarnavadi vati 500mg orally four tablets twice a day for 30 days is not effective in sthaulya with special reference to Dyslipidemia in HTN
Drug- Punarnavadi Vati
Dose- 500mg 4 tablets twice a day
Anupana- koshna jala
Sevankala : Bhojanpashchat
Duration : 30 Days
Ahara(Diet) : As per pathyakara Ahara mentioned in Ayurvedic texts.
Vihara : As per pathyakara Vihara mentioned in Ayurvedic texts
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 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
- •1 efficacy of punarnavadi vati in the management of sthaulya with special reference to dyslipidemia in hypertension.
- •2 Patients from age group of 18 to 60years irrespective of gender, religion, socio-economic status, marital status.
- •2 Patients of Sthaulya with hypertension as per signs and symptoms BMI between 25 to
- •Including overweight Obese class 1 as per signs and symptoms mentioned in Ayurvedic Samhitas.
- •3 Waist To hip Ratio more than
- •4 Patient with known case of HTN Systolic BP should be less than 160 Diastolic BP should be less than 100.
排除标准
- •1 Pregnant and lactating women.
- •2 Acute life threatening conditions like CVA, CA, Acute MI, DM I and Insulin Dependent.
- •3 Known Cases of Hypothyroidism and hyperthyroidism.
- •4 Patient with Systolic BP more than 160 diastolic BP more than 99.
结局指标
主要结局
to evaluate the efficacy of Punarnavadi Vati In Sthaulya with special reference to Dyslipidemia in Hypertension.
时间窗: 15th and 30th day
次要结局
- 1 To evaluate the efficacy of Punarnavadi Vati in Sthaulya with special reference to dyslipidemia in HTN.(2 To study the etiopathology of Sthaulya and Dyslipidemia)
研究者
Dr Shweta Santosh Shirsath
Seth Chandanmal Mutha Aryangla Vaidyak Mahavidyalaya, Satara