Ayurvedic Management of Chronic Kidney Disease

NCT02477163 | Completed DMC

• 1 other identifier: JSAM/IECHR/13-14/362-2
• Study Type: interventional
• Target: 521
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetic Nephropathy; Hypertensive Nephropathy

Keywords

Nephropathy; Chronic Renal Failure; Chronic Kidney Disease; Chronic Renal Disease; Ayurveda; Herbal treatment

Outcome Measures

Primary Outcomes (2)

• 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 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)

  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

Study Arms (1)

single group

EXPERIMENTAL

Patients of chronic renal failure

Other: Ayurveda treatment

Interventions

Ayurveda treatment OTHER

1. Gokshuradi Guggulu (compound Ayurvedic preparation: Gokshura + Guggulu + Triphala + Trikatu + Musta) - 1 g, 3 times in a day after food with warm water. 2. 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. 3. Rasayan Churna (powder of Gokshura + Amalaki + Guduchi in equal quantities ) - 3 g, 3 times a day with water. 4. Bhumyamalaki (Tamalaki Rasayan) tablet - 1 g, 2 times in a day after food with water. 5. Uricare (of Punarvasu Pharmacy, Petlad road, Nadiad) tablet - 1 g, 3 times in a day after food with warm water. 6. Niruha Basti (procto-colonic administration of ayurvedic medicine) with Punarnavadi kvath (decoction) - in the morning, before one hour of the lunch.

single group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• J.S. Ayurveda College: lead

Study Sites (1)

P D Patel Ayurveda Hospital

Nadiād, Gujarat, 387001, India

Location

MeSH Terms

Conditions

Diabetic Nephropathies; Hypertensive Nephropathy; Kidney Diseases; Kidney Failure, Chronic; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Renal Insufficiency; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Manishkumar V Patel, MD(Ayurveda)

  J S Ayurveda College,College Road, Nadiad

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pre-post design

Study Record Dates

• First Submitted: June 11, 2015
• First Posted: June 22, 2015
• Study Start: January 1, 2014
• Primary Completion: June 30, 2021
• Study Completion: April 30, 2022
• Last Updated: August 12, 2022

Record last verified: 2021-07

Locations

IN (1)