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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Healthy Human Volunteers |
healthy adults |
|
Intervention / Comparator Agent
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
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. |