An Observational Clinical Study to Determine the Effect of Multi-modal Ayurvedic Treatment in the Patients of Chronic Kidney Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 521
- 试验地点
- 2
- 主要终点
- Changes in the value of laboratory investigations
研究概览
简要总结
The purpose of this study is to determine the effect of multi-dimentional ayurvedic treatment in the patients of various types of chronic kidney disease.
详细描述
Ayurvedic treatment includes some complex classical herbal formulations and Niruha basti (procto-colonic administration of ayurvedic medicines mainly contained decoction of punarnavadi compound, rocksalt, sesame oil and mixture of some herbal poweders) will be given to the patients of chronic kedney disease who are not on dialysis. Patients of CKD of various etiology will be grouped accordingly and will get the same treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients having a confirm diagnosis of chronic kidney disease with GFR level < 60mL/min and persistent (present for > 3 months) indicates substantial reduction in kidney function. Confirmation of diagnosis with ultrasound of KUB, indicating reduction of kidney size and / or cortico-medullary difference.
排除标准
- •Female patients having pregnancy, breast feeding or post-delivery period.
- •Patients who are on dialysis treatment from more than 6 months period. Patients who are already operated for renal transplantation and then having nephropathy.
- •Patients with some serious illness like cardio-vascular diseases, acute mental disorders, serious acute organic diseases, serious chronic co-morbidity, hypo or hyper thyroidism, other kidney, liver or metabolic disorders etc.
结局指标
主要结局
Changes in the value of laboratory investigations
时间窗: 4 weeks
All the related laboratory investigations will be done before and after the treatment. Effect will be assessed with the help of reduction level in serum creatinine(in mg /dl), blood urea(in mg/dl), serum uric acid(in mg/dl) and improvement in hemoglobin(in gm%) and serum electrolytes level(in mmol/l).
Improvement in the signs and symptoms
时间窗: 4 weeks
Following grade score will be used to measure the improvement in all the patients at the initial level and after the treatment. Grade score of signs and symptoms 1. Oedema: No oedema(0); Slight oedema on lower extremties(1); Severe oedema on lower extrimities(2); Anasarca(3) 2. General weakness: No weakness(0); Mild weakness(1); Moderate weakness(2); Severe weakness(3) 3. Loss of appetite: Good appetite(0) Mild loss of appetite(1); Moderate loss of appetite(2); Complete loss of appetite(3) 4. Nausea / Vomiting: Absent(0); Occasional(1); Once or twice a week(2); Daily(3) 5. Muscle cramps: Absent(0); Occasional(1); Once or twice a week(2); Daily(3) 6. Breathlessness: Absent(0); On fast walking or climbing stairs(1); Sometimes at rest(2); Generally occurs at rest(3) 7. Hiccup: Absent(0); Occasional(1); Once or twice a week(2); Daily(3) 8. Pruritus: Absent(0); Mild(1); Moderate(2); Severe(3)
次要结局
未报告次要终点