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CTRI Number  CTRI/2024/10/074564 [Registered on: 01/10/2024] Trial Registered Prospectively
Last Modified On: 26/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Exploring the outcome of Combined Ayurvedic Treatments on Chronic Kidney Disease patients: An Observational study 
Scientific Title of Study   An observational study to explore the outcome of multimodal Ayurveda treatment in the management of chronic kidney disease-A prospective cohort study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Anuradha 
Designation  MD Scholar, Department of Kayachikitsa 
Affiliation  All India Institute Of Ayurveda 
Address  618(Seminar Hall) Department Of Kayachikitsa All India Institute Of Ayurveda Gautampuri Sarita vihar New Delhi South DELHI 110076 India

South
DELHI
110076
India 
Phone  8587899505  
Fax    
Email  anu278388@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DrVG Huddar 
Designation  Additional Professor  
Affiliation  All India Institute Of Ayurveda 
Address  621 Department Of Kayachikitsa All India Institute Of Ayurveda Gautampuri Sarita vihar New Delhi South DELHI 110076 India

South
DELHI
110076
India 
Phone  9986697942  
Fax    
Email  drvghuddar@gmail.com  
 
Details of Contact Person
Public Query  
Name  DrVG Huddar 
Designation  Additional Professor  
Affiliation  All India Institute Of Ayurveda 
Address  621 Department Of Kayachikitsa All India Institute Of Ayurveda Gautampuri Sarita vihar New Delhi South DELHI 110076 India

South
DELHI
110076
India 
Phone  9986697942  
Fax    
Email  drvghuddar@gmail.com  
 
Source of Monetary or Material Support  
All India Institute Of Ayurveda Gautampuri Sarita Vihar New Delhi South DELHI 110076 India  
 
Primary Sponsor  
Name  All India Institute Of Ayurveda  
Address  Gautampuri Sarita Vihar New Delhi 110076 
Type of Sponsor  Government medical college 
 
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 Anuradha  All India Institute Of Ayurveda   OPD No. 5 (Integrative Nephrology Unit-Kayachikitsa) Department of Kayachikitsa All India Institute Of Ayurveda
South
DELHI 		 8587899505

anu278388@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
All India Institute Of Ayurveda Institutional Ethics Committee  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: MUTRAGHATAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Diagnosed cases of CKD with classical signs and symptoms.
2.According to International Classification of Disease 11th Revision (ICD-11) guidelines:-
GB61 Chronic kidney disease
GB61.0 Chronic kidney disease, stage 1
GB61.1 Chronic kidney disease, stage 2
GB61.2 Chronic kidney disease, stage 3a
GB61.3 Chronic kidney disease, stage 3b
GB61.4 Chronic kidney disease, stage 4
GB61.5 Chronic kidney disease, stage 5
 
 
ExclusionCriteria 
Details  1.Patients present with complain of Tuberculosis, Carcinoma ,Pregnant and lactating mother.
2.Patient with Hepatorenal Syndrome.
3.Patient with uncontrolled Diabetes Mellitus and Hypertension.
4.Patient with Ischemic heart disease and other conditions which may become an outliers due to differed response
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Changes in the Renal function test and clinical symptoms of CKD after observing for 12weeks  day0
day15
day30
day45
day60
day75
day90 
 
Secondary Outcome  
Outcome  TimePoints 
1. Changes in the Quality of life, after observing for 12weeks.
2. Come up with the draft suggesting the trend of present clinical practice in CKD and further may help for developing a protocol.
3.To compare the safety parameters in terms of hemogram, LFT and KFT in pre and post treatment.

 		 day0
day15
day30
day45
day60
day75
day90 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   09/10/2024 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [anu278388@gmail.com].

  6. For how long will this data be available start date provided 07-06-2026 and end date provided 07-06-2029?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   Chronic Kidney Disease(CKD) is worldwide threat to public health and multiply risk on major non-communicable diseases, including CVD , DM Type 1 & 2 . However , with ageing CKD become a leading cause of mortality. In India, the  annual prevalence of CKD is 800 per million population (pmp), and the incidence of end-stage renal disease (ESRD) is 150–200 pmp. with majority of the patients requiring hemodialysis and transplant, this poses significant financial burden over the affected families with approximately 146% unable to afford medical bills. . Inspite of treatment, there is significant reduction in the quality of the life of the patients. thus, increasing number of patients resort to AYUSH systems of medicine for care. The present study is an effort to document the outcomes of Ayurveda clinical practice in the management of CKD, both in terms of objective and subjective parameters. this will serve as a reference for developing future hypothesis for conducting large scale clinical trials. 

  
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