Ayurvedic Management of Chronic Kidney Disease

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetic Nephropathy; Hypertensive Nephropathy
• Intervention / Treatment: Other: Ayurveda treatment

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 521
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Gujarat
    • Nadiad, Gujarat, India, 387001
      • P D Patel Ayurveda Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: single group; Patients of chronic renal failure

Other: Ayurveda treatment; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: J.S. Ayurveda College
• Investigators: Principal Investigator: Manishkumar V Patel, MD(Ayurveda), J S Ayurveda College,College Road, Nadiad

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2014
• Primary Completion (Actual): June 30, 2021
• Study Completion (Actual): April 30, 2022

Study Registration Dates

• First Submitted: June 11, 2015
• First Submitted That Met QC Criteria: June 19, 2015
• First Posted (Estimate): June 22, 2015

Study Record Updates

• Last Update Posted (Actual): August 12, 2022
• Last Update Submitted That Met QC Criteria: August 10, 2022
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Chronic Kidney Disease; Chronic Renal Failure; Nephropathy; Chronic Renal Disease; Herbal treatment; Ayurveda
• Additional Relevant MeSH Terms: Urologic Diseases; Endocrine System Diseases; Diabetes Complications; Diabetes Mellitus; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic; Diabetic Nephropathies
• Other Study ID Numbers: JSAM/IECHR/13-14/362-2