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NCT Number: NCT02477163

Ayurvedic Management 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.

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Key information

Conditions

Diabetic Nephropathy Chronic Disease Diabetes Complications Diabetes Mellitus Diabetic Nephropathies Disease Attributes Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hypertensive Nephropathy Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

P D Patel Ayurveda Hospital

Nadiād, Gujarat, 387001, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ayurveda treatment

Other
  • 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.

Primary outcomes

  1. Improvement in the signs and symptoms

    Time frame: 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

    • 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)

  2. Changes in the value of laboratory investigations

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

J.S. Ayurveda College

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2021
Study completion
2022
First posted
Jun 22, 2015
Registry last updated
Aug 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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