Efficacy of Ayurvedic Multi Drug Therapy along with Erandamooladi Basti in the Management of Chronic Kidney Disease-An Open Labelled Randomized Controlled Clinical Trial
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
- 1
- 主要终点
- Reduction in serum creatinine and increase in eGFR
研究概览
简要总结
Purpose of the Research:
Chronic Kidney Diseaserefers to an irreversible destruction of the kidney function persistent formore than or equal to3months.Prevalence of this disease is about 250 millionpeople in the world.In India prevalence is about 800 per million population.Themodern management of CKD is worth costlyand the ultimate remedy is renal transplantation.The increase in the prevalenceof kidney disease progressing to End Stage Renal Disease and the consequent financialburden of renal replacement therapy create imbalance in the economy ofDeveloping country like India.Moreover,main causes of CKD are Diabetes andHypertension.By 2030,India is expected to have worlds largest population ofpatients with Diabetes.So it’s a humbleeffort to find an alternate treatment for safe,effective as well as cheapermedication when compared to modern medicine.
The present study aims to asses and compare the effect of Ayurvedicmulti drug therapy along with Erandamooladi Basti in the managementof Chronic Kidney Disease.
Information about Trialdrug and Panchakarma procedure:
The trial drug includesKashayam of Varuna Sigru(40ml two times daily ,before food),GokshuradiGuggulu(two tab thrice ,before food),Guduchyadi Choornam(5gmtwice,after food)and Gokshuradi Choornam(3gm twice before food)internally for 20-22 days.The Panchakarma procedure we are testing inthis study is the Erandamooladi Basti(internal administration ofmedicated Basti dravya through anal route)for 16 days.The trial drugformulations used in this study are described in Ayurvedic classicaltexts and are prepared from the Pharmacy of Gujrat Ayurved University,Jamnagar andnone of them has reported any side effects.We assure that this formulation hasbeen prepared with complete care and purification methods if required.
Description of ResearchProcess:
In the presentstudy,participants which clinically diagnosed and confirmed cases of ChronicKidney Disease will be divided in to two groups,with a minimum of 15 patientsin each group.
Group A:
Participants willing totake Ayurvedic multi drug therapy and Erandamooladi Basti areincluded in Group A.The treatment protocol includes trikatu choornam3-5gm for 3-5 days for improving digestive power,Gokshura,VarunaSigru kwath diguggulu,Guduchyadi Samana choornam,Gokshura choornam for 20-22days(doses asabove mentioned*).Panchakarma* procedure includes internal administrationof medicated Erandamooladi Basti dravya for 12days and AnuvasanaBasti(using medicated thila thaila for 4 days) in the order of three *ErandamooladiBasti (*480ml)followed by one thila thaila Basti(60ml).
Group B:
Participants willing totake conventional medicine(Allopathic)medications are included in thisgroup.The medications include AntiHypertensive drugs,drugs which reducesmetabolic acidosis,Iron supplements,Vitamin B Complex medications,Calciumtablets etc.This group considered to be the standard controlled group.
Side Effects:
We will follow closelyand keep track of any unwanted effects .Till now ,no side effects had beenreported on the internal administrationof mentioned trial drugs and the administration of Erandamooiadi Bastiprocedure.
Benefits:
This project will helpus to resolve the research question.There may not be any benefit for thesociety at this stage of the research,but future generations are likely to bebenefitted,as it helps to find out proper treatment protocol for the managementof Chronic Kidney Disease.
The information that wecollect from this research project will be kept confidential,all outcomes willbe noted in tabular form and appropriate statistical tests will be applied tocompare the effect.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
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.Patients having signs and symptoms of chronic kidney disease.
- •2.Patients of both genders between 18-60yrs of age.
- •3.Patients willing and able to participate.
- •4.Patients with serum creatinine level between1.2- 6 mg/dl will be included in the study.
- •5.Patients with serum urea level with in 120mg/dl 6.Patients who are yogya for basti karma.
排除标准
- •1.Female patients having pregnancy, breast feeding or post-delivery period.
- •2.Patients of end stage renal failure.
- •3.Patients who are on dialysis treatment for more than 1-month period.
- •4.Patients who are already operated for renal transplantation and then having nephropathy.
- •5.Patients of hepato-renal insufficiency or renal insufficiency due to hemodynamic circulatory disorders and CCF.
- •6.Patients having some serious illness like cardio-vascular diseases, acute mental disorders, serious acute organic diseases, serious chronic co-morbidity, hypo or hyper thyroidism.
- •7.Patients having haemoglobin concentration below 8gm.
- •8.Having uncontrolled Hypertension(systolic<180mm/Hg, diastolic<100mm/Hg) and Diabetes mellitus (FBS-<200mg/dl) 9.Patients with serum urea level above 120mg/dl 10.Patients having symptoms of Uremia.
结局指标
主要结局
Reduction in serum creatinine and increase in eGFR
时间窗: After 4 weeks
次要结局
- Reduction in signs and symptoms of CKD(After 4 week)