| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N189||Chronic kidney disease, unspecified. Ayurveda Condition: MUTRAVAHASROTOVIKARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
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. |