Ayurvedic Management of Chronic Kidney Disease

Diabetic Nephropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02477163
• Other study ID #: JSAM/IECHR/13-14/362-2
• Status: Completed
• Phase: N/A
• Start date: January 2014
• Est. completion date: April 30, 2022

Study information

• Verified date: July 2021
• Source: J.S. Ayurveda College
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 521
• Est. completion date: April 30, 2022
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Nephropathies
• Diabetic Nephropathy
• Hypertensive Nephropathy
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

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.

Locations

Country	Name	City	State
India	P D Patel Ayurveda Hospital	Nadiad	Gujarat

Sponsors (1)

Lead Sponsor	Collaborator
J.S. Ayurveda College

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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