| CTRI Number |
CTRI/2025/07/091414 [Registered on: 22/07/2025] Trial Registered Prospectively |
| Last Modified On: |
22/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Longitudinal |
| Study Design |
Other |
|
Public Title of Study
|
Study to find the effect of anxiety on digestive fire in deha prakriti |
|
Scientific Title of Study
|
Observational study to assess the effect of chinta (anxiety) on agni in deha prakriti |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Deepti Sharma |
| Designation |
PG scholar |
| Affiliation |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
| Address |
Patanjali Bhartiya Ayurvigyan evam Anusandhan Sansthan,
Room no.- 110, PG room, Department of kriya sharir, Patanjali yogpeeth phase-I, Maharishi Dayanand Gram, Delhi-Haridwar National Highway-58
Hardwar
UTTARANCHAL
249405
India |
| Phone |
7310800204 |
| Fax |
|
| Email |
deeptisharma929@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Jaibheem |
| Designation |
Associate Professor |
| Affiliation |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
| Address |
Patanjali Bhartiya Ayurvigyan evam Anusandhan Sansthan,
Room no.- 110, PG room, Department of kriya sharir, Patanjali yogpeeth phase-I, Maharishi Dayanand Gram, Delhi-Haridwar National Highway-58
Hardwar
UTTARANCHAL
249405
India |
| Phone |
9986131560 |
| Fax |
|
| Email |
jaibheem.reddy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepti Sharma |
| Designation |
PG scholar |
| Affiliation |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
| Address |
Patanjali Bhartiya Ayurvigyan evam Anusandhan Sansthan,
Room no.- 110, PG room, Department of kriya sharir, Patanjali yogpeeth phase-I, Maharishi Dayanand Gram, Delhi-Haridwar National Highway-58
Hardwar
UTTARANCHAL
249405
India |
| Phone |
7310800204 |
| Fax |
|
| Email |
deeptisharma929@gmail.com |
|
|
Source of Monetary or Material Support
|
| Patanjali Bhartiya Ayurvigyan evam Anusandhan Sansthan, Haridwar |
|
|
Primary Sponsor
|
| Name |
Dr Deepti Sharma |
| Address |
Patanjali Bhartiya Ayurvigyan evam Anusandhan Sansthan,
Patanjali yogpeeth phase-I, Maharishi Dayanand Gram, Delhi - Haridwar National Highway-58, Haridwar, Uttarakhand-249405 |
| Type of Sponsor |
Private medical college |
|
|
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 Deepti Sharma |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
Patanjali Bhartiya Ayurvigyan evam Anusandhan Sansthan, Room no.- 110, PG room, Department of kriya sharir, Patanjali yogpeeth phase-I, Maharishi Dayanand Gram, Delhi-Haridwar
National Highway-58, Haridwar, Uttarakhand-249405
Hardwar
UTTARANCHAL |
7310800204
deeptisharma929@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Apparently healthy individuals |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
Healthy subjects within the age group of 19 to 35 years.
Exam appearing student |
|
| ExclusionCriteria |
| Details |
Subjects below 18 years of age and above 35 years of age.
Individuals suffering from metabolic disorders.
History of GI related issues.
Subject on any long term medication.
History of any psychiatric illness. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
prakriti scale
Kishore Patwardhan Agni Assessment Scale
Hamilton anxiety scale
|
12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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)
|
02/08/2025 |
| 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="0"
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 - NO
|
|
Brief Summary
|
This study is a longitudinal, observational trial to evaluate the effect of chinta (anxiety) on agni in deha prakriti . In this study the data will be collected from various subjects within 1 year . Prakriti scale will be evaluated through interview by principal investigator and agni assessment will be done by Kishore patwardhan agni assessment scale , anxiety assessment will be done by Hamilton anxiety scale . The data will be evaluated statistically to find out if there is any effect of chinta (anxiety) on agni in deha prakriti. |