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CTRI Number  CTRI/2024/05/067083 [Registered on: 09/05/2024] Trial Registered Prospectively
Last Modified On: 07/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Ayurveda diagnostic algorithm for chronic kidney disease 
Scientific Title of Study   A study to develop and validate an Ayurveda diagnostic algorithm for chronic kidney disease 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ribin V P 
Designation  PhD Scholar 
Affiliation  All India Institute of Ayurveda 
Address  Department of Roganidana Evam Vikriti Vigyan, 3rd floor, Acasdemic block, All India Institute of Ayurveda, Gouthampuri, p.o. Sarita Vihar, South Delhi

South
DELHI
110076
India 
Phone  8086393469  
Fax    
Email  ribingangadharan93@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Prof Dr Anand More 
Designation  Professor and HOD, Department of Roganidana Evam Vikriti Vigyana 
Affiliation  All India Institute of Ayurveda 
Address  Room No. 305, Department of Roganidana Evam Vikriti Vigyan, 3rd floor, Acasdemic block, All India Institute of Ayurveda, Gouthampuri, p.o. Sarita Vihar, South Delhi

South
DELHI
110076
India 
Phone  9422025732  
Fax    
Email  drmoreanand@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Prof Dr Anand More 
Designation  Professor and HOD, Department of Roganidana Evam Vikriti Vigyana 
Affiliation  All India Institute of Ayurveda 
Address  Room No. 305, Department of Roganidana Evam Vikriti Vigyan, 3rd floor, Acasdemic block, All India Institute of Ayurveda, Gouthampuri, p.o. Sarita Vihar, South Delhi

South
DELHI
110076
India 
Phone  9422025732  
Fax    
Email  drmoreanand@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Ayurveda 
 
Primary Sponsor  
Name  All India Institute of Ayurveda 
Address  All India Institute of Ayurveda, Gouthampuri, p.o. Sarita Vihar, South Delhi - 110076 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ribin V P  All India Institute of Ayurveda  OPD No. 3 & 5, Hospital block, All India Institute of Ayurveda, Gouthampuri, p.o. Sarita Vihar, South Delhi
South
DELHI 
8086393469

ribingangadharan93@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Division of Translational Research & Biostatistics  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N189||Chronic kidney disease, unspecified. Ayurveda Condition: MUTRAVAHASROTOVIKARAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  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. 
 
ExclusionCriteria 
Details  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.  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Development of validated Ayurveda Diagnostic Algorithm for chronic kidney disease  single visit 
 
Secondary Outcome  
Outcome  TimePoints 
Assessment of predominant Prakriti in chronic kidney disease patients  Single visit 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   20/05/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
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. 
 
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