Ayurvedic Management of Chronic Kidney Disease

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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An Observational Clinical Study to Determine the Effect of Multi-modal Ayurvedic Treatment in the Patients of Chronic Kidney Disease

Conditions
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Diabetic Nephropathy, Hypertensive Nephropathy

Intervention / Treatment
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* Other: Ayurveda treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Pre-post design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: single group<br>Patients of chronic renal failure | Other: Ayurveda treatment<br>* Gokshuradi Guggulu (compound Ayurvedic preparation: Gokshura + Guggulu + Triphala + Trikatu + Musta) - 1 g, 3 times in a day after food with warm water. Varunadi kvath (ingredients: Varuna tvak + Bilva moola + Apamarga + Chitrak moola + Arani + Shigru + Bruhati + Kirattikta + Karanja + Shatavari) - 40 ml 2 times in a day after food. Rasayan Churna (powder of Gokshura + Amalaki + Guduchi in equal quantities ) - 3 g, 3 times a day with water. Bhumyamalaki (Tamalaki Rasayan) tablet - 1 g, 2 times in a day after food with water. Uricare (of Punarvasu Pharmacy, Petlad road, Nadiad) tablet - 1 g, 3 times in a day after food with warm water. Niruha Basti (procto-colonic administration of ayurvedic medicine) with Punarnavadi kvath (decoction) - in the morning, before one hour of the lunch.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in the signs and symptoms | 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 Oedema: No oedema(0); Slight oedema on lower extremties(1); Severe oedema on lower extrimities(2); Anasarca(3) General weakness: No weakness(0); Mild weakness(1); Moderate weakness(2); Severe weakness(3) Loss of appetite: Good appetite(0) Mild loss of appetite(1); Moderate loss of appetite(2); Complete loss of appetite(3) Nausea / Vomiting: Absent(0); Occasional(1); Once or twice a week(2); Daily(3) Muscle cramps: Absent(0); Occasional(1); Once or twice a week(2); Daily(3) Breathlessness: Absent(0); On fast walking or climbing stairs(1); Sometimes at rest(2); Generally occurs at rest(3) Hiccup: Absent(0); Occasional(1); Once or twice a week(2); Daily(3) Pruritus: Absent(0); Mild(1); Moderate(2); Severe(3) | 4 weeks | 
| Changes in the value of laboratory investigations | 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). | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nephropathy, Chronic Renal Failure, Chronic Kidney Disease, Chronic Renal Disease, Ayurveda, Herbal treatment