an open label control clinical study to evaluate the efficacy of trinpanchamool kwath siddha basti in Chronic kidney disease.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 3
- 主要终点
- 1 reducion in biomarkers (serum createnine, bloodurea and eGFR) of CKD
研究概览
简要总结
Chronic Kidney Disease (CKD), is a condition in which kidney function gradually detoriates over months or years. The world is facing a global epidemic of Chronic Kidney Disease. There are several conservative therapeutic options available in modern medicines, each with its own set of advantages and disadvantages. CKF treatment is an organ based, and there are only two conservations measures: dialysis and kidney transplantation, according to present research. Dialysis is not a treatment for renal failure; it may prolong life but does not cure it. Kidney transplantation is a very expensive procedure and patient must take extremely expensive immunosuppressive medicines for the rest of his or her life, which destroys the body defense system.In India, prevalence of kidney disease is increases due to sedentary life style, eating habits, hypertension, and uncontrolled diabetes.
Hence there is an alarming need of some alternate approach which is safe and effective in management of CKD, therefore this study has been taken to apply ayurveda principals on CKD, with growing number of cases of CKD and keeping in mind the available conventional line of treatment and its financial burden on patient, ayurveda through its holistic line of management.The formulation(Trinpanchamool) used in this study have been included in the mootra virechaniya mahakashaya by acharya charak. They are capable of treating many disorders related to the urinary system. This kwath has vata-pitta shamak property, is diuretic, kidney stimulant, and hematopoietic in action. Trinapanchamoola kwath not only reduces the fuild overload due to renal impairment by diuretic action but also strengthen the renal system.panchakarma procedure "Basti karma" is very much effective to expel the dosas out of the body and also works well in urinary system and vata vikar.
The present study is planned to evaluate the efficacy of trinpanchamool kwath siddha basti in CKD. There will be 2 groups in the study, Group A (control group) will be given modern line of treatment under supervission of nephrologist aand another group B will be given Trinpanchammol kwath siddha basti in 2 courses of yog basti (8 days).The parameters- serum cretinine, bloodures, e-GFR, Hb% will be noted before (zero day),during(9th, 25th,34th day) and after the treatment(49th day). 2 Followups will be done on day 64 &79th day.
the data collected will be statistically analysed and will be presented in the form of dissertation.
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
- 20.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Diagnosed patients of CKD or patients having clinical sign and symptoms of CKD Clinically stable patients of stage 1 to stage 3 Patients having Serum Creatinine level between 1.4mg/dl to ≤ 5mg/dl Age group between 20- 65 yearS Patient fit for basti karma and willing to participate in clinical trial.
- •Nondiabetic and if Diabetic- HbA1c in % less than 7.0.
排除标准
- •Stage: Patient of any stage requiring dialysis/ who is already on dialysis Patient with severe toxicity Patient with End stage renal disease (ESRD) Patient having poly cystic kidney or any other kidney disorder Patient with autoimmune or genetic disorder or carcinoma Pregnant female and lactating mother Patient having serious systemic disorders (like chronic heart disease etc) Patient with hypertension ≥150/100 mmHg.
结局指标
主要结局
1 reducion in biomarkers (serum createnine, bloodurea and eGFR) of CKD
时间窗: 1 reducion in biomarkers (serum createnine, bloodurea and eGFR) of CKD 48 day
次要结局
- Efficacy of the trinpanchamool kwath siddha Basti in reduction of Subjective Parameters/symptoms(48 days)
研究者
BHANU PRIYA KAUSHIK
SHRI KRISHNA AYUSH UNIVERSITY KURUKSHETRA HARYANA