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Clinical Trials/CTRI/2024/05/067083
CTRI/2024/05/067083Not yet recruitingNot Applicable

A study to develop and validate an Ayurveda diagnostic algorithm for chronic kidney disease

All India Institute of Ayurveda1 site in 1 country200 target enrollmentStarted: May 20, 2024Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
200
Locations
1
Primary Endpoint
Development of validated Ayurveda Diagnostic Algorithm for chronic kidney disease

Study Overview

Brief Summary

RESEARCH QUESTION

Is it possible to develop a diagnostic algorithm to identify the involved Dosha, Dushya, and Srotas in the pathogenesis of Chronic Kidney Disease?

RESEARCH GAP

As per the scholar’s knowledge Interventional research has been done on the therapeutic aspect of CKD, while no studies have been conducted on the Ayurveda diagnostic algorithm for CKD.

NEED OF THE STUDY

The Ayurvedic classics do not explicitly mention chronic kidney disease (CKD), but scattered references to the condition can be found in various chapters and under numerous headings. Even though some features of CKD have similarities with conditions like Lalameha (albuminuria), Kaphaja Shotha, Mutrasaada, Prameha Upadrava, Chardi ,etc. explained in Ayurveda, it still seems to be an Anukta Vyadhi. The degree of involvement of Ayurvedic pathogenic components like Dosha, Dushya, and Srotas may vary according to the patient and the presentation of the disease. Designing an Ayurvedic treatment strategy requires consideration of the aforementioned factors. So if there is an Ayurvedic diagnostic algorithm that recognizes the above factors, it may help the clinicians effectively plan the treatment protocol.

AIM & OBJECTIVES

AIM

To develop and validate an Ayurveda diagnostic algorithm to identify involved Dosha, Dushya & Srotas in chronic kidney disease.

OBJECTIVES PRIMARY

To develop and validate an Ayurveda diagnostic algorithm for chronic kidney disease.

SECONDARY

To assess the dominant Prakriti in patients of chronic kidney disease.

METHODOLOGY

Diagnosed cases of Chronic Kidney Disease (100 cases) will be selected and will be divided into non dialysis participants and dialysis undergoing patients and 100 participants having risk for developing CKD such as diabetes mellitus & hypertension of chronicity more than 5 years, family history of CKD and history of kidney injury will be selected. Signs, symptoms and other relevant clinical parameters present in cases will be recorded using clinical proforma. The recorded signs & symptoms will be understood in Ayurvedic terminology with the help of review of literature, articles and based on expert opinion. These observations will be categorized based on the involved Dosha, Dushya, Srotas, etc. Ayurvedic diagnostic algorithm will be developed based on the categories and sent to 20 experts for evaluation. The diagnostic algorithm will be then clinically applied to a population of 100 CKD patients and 100 participants having risk for developing CKD such as diabetes mellitus & hypertension of chronicity more than 5 years, family history of CKD and history of kidney injury.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
3.00 Year(s) to 80.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Diagnosed patients with conditions belongs to ICD-10-CM/PCS MS-DRG v38.0 definitions manual codes N181, N182, N1830, N1831, N1832, N184, N185, N189 Diagnosed cases of chronic kidney disease irrespective of their age, gender, religion, economic status willing to provide informed consent for the study Patients with controlled hypertension.

Exclusion Criteria

  • Patients suffering from tuberculosis, malignancy, associated liver disease.
  • Uncontrolled diabetes and hypertension.
  • Patients with cardiac vascular diseases.
  • Patients with renal failure.
  • HIV-associated nephropathy and transplant allograph failure.
  • History of previous kidney transplant.

Outcomes

Primary Outcomes

Development of validated Ayurveda Diagnostic Algorithm for chronic kidney disease

Time Frame: single visit

Secondary Outcomes

  • Assessment of predominant Prakriti in chronic kidney disease patients(Single visit)

Investigators

Sponsor Class
Research institution and hospital
Responsible Party
Principal Investigator
Principal Investigator

Ribin V P

All India Institute of Ayurveda

Study Sites (1)

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