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CTRI Number  CTRI/2022/04/041747 [Registered on: 08/04/2022] Trial Registered Prospectively
Last Modified On: 04/06/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   A study to compare different Prakriti prediction methods  
Scientific Title of Study   Comparing Prakriti (Ayurveda constitution types) prediction between Ayurvedic clinical methods and questionnaire-based assessment: A cross-sectional study 
Trial Acronym  COMPAQ 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Gautam Sharma 
Designation  Prof. In charge, Center for Integrative Medicine and Research, Prof. Dept. of Cardiology 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Room no 7004, 7th floor, Convergence Block, All India Institute of Medical Sciences, New Delhi

South
DELHI
110029
India 
Phone  011-26549320  
Fax    
Email  drgautamsharma12@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Gautam Sharma 
Designation  Prof. In charge, Center for Integrative Medicine and Research, Prof. Dept. of Cardiology 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Room no 7004, 7th floor, Convergence Block, All India Institute of Medical Sciences, New Delhi

South
DELHI
110029
India 
Phone  011-26549320  
Fax    
Email  drgautamsharma12@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Gautam Sharma 
Designation  Prof. In charge, Center for Integrative Medicine and Research, Prof. Dept. of Cardiology 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Room no 7004, 7th floor, Convergence Block, All India Institute of Medical Sciences, New Delhi

South
DELHI
110029
India 
Phone  011-26549320  
Fax    
Email  drgautamsharma12@gmail.com  
 
Source of Monetary or Material Support  
Center for Integrative Medicine and Research, Room No 7004, 7th floor, Convergence Block, AIIMS, New Delhi 
 
Primary Sponsor  
Name  Center for Integrative Medicine and Research 
Address  Room No 7004, 7th floor, Convergence Block, AIIMS, New Delhi 
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 Gautam Sharma  Center for Integrative Medicine and Research  Room no 7004, 7th floor, Convergence Block, AIIMS New Delhi
South
DELHI 
011-26549320

drgautamsharma12@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  healthy adults  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Both 
Details  1. Subjects willing to participate in the study, who give informed written consent and are able to comply with the study visit requirements
2. Able to understand Hindi and English language properly for comprehending the Prakriti assessment
 
 
ExclusionCriteria 
Details  1. Individuals with diagnosed major disease conditions (self-reported) such as advanced
malignancies, significant systemic diseases like chronic kidney diseases, severe hepatic, pulmonary, cardiac disease, and other neurologic diseases
2. Individuals diagnosed clinically with major psychiatric disorder (e.g., psychosis, major depression, bipolar disorder), that can interfere with Prakriti assessment
3. Unable to comply with the study requirements
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Sensitivity and Specificity of two questionnaires based approaches for ten Prakriti types by considering the prakriti assignment by Ayurvedic physician as gold standard.  data will be recorded only once (cross sectional study) 
 
Secondary Outcome  
Outcome  TimePoints 
Agreement between CSIR Prakriti questionnaire and CCRAS Prakriti questionnaire with a reference of Ayurvedic clinicians assessment.  data will be recorded only once (cross sectional study) 
 
Target Sample Size   Total Sample Size="197"
Sample Size from India="197" 
Final Enrollment numbers achieved (Total)= "138"
Final Enrollment numbers achieved (India)="138" 
Phase of Trial   N/A 
Date of First Enrollment (India)   18/04/2022 
Date of Study Completion (India) 01/02/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
published in 2024 International journal of community medicine and public health. doi:10.18203/2394-6040.ijcmph20243293 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

In the Ayurvedic system of medicine, prevention and therapeutic measures are based on understanding and assessing the individual constitution, or Prakriti, of patients for choosing the most appropriate regimen, drugs, and lifestyle measures. So, standardization of the Prakriti assessment technique is essential for applying the personalized approach and getting the maximum benefit of Ayurvedic diagnostic, therapeutic, and prophylactic measures. Among the majorly used Prakriti questionnaires, the CSIR-TRISUTRA   consortium initiative is an integrative approach involving the identification of molecular correlates of Prakriti as predictive and prognostic markers of disease as well as therapeutic response. A comprehensive       Prakriti assessment model has been developed by CCRAS (Central      Council for Research in Ayurvedic Sciences) and is being used for testing healthy volunteers. C-DAC is also utilized by several research studies for prognosis, evaluating therapeutic efficacy, and finding associations of phenotypes and genotypes.

Though all the questionnaires are derived from the Ayurvedic classical texts they vary in their construct and approach. Scare data is available regarding their standardization and validation procedures. There are no studies available, evaluating the agreement between different questionnaires and their comparison with physician’s Prakriti assessment. Though the Prakriti assessment questionnaires are based on Ayurvedic classical texts, they differ in their derivation, structure, and algorithms for scoring and assignment of the Prakriti. Therefore, there is a need to evaluate the agreement in Prakriti prediction by Ayurveda physicians as a reference to the Questionnaire-based Prakriti assignment. 

 
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