| CTRI Number |
CTRI/2025/06/088971 [Registered on: 17/06/2025] Trial Registered Prospectively |
| Last Modified On: |
17/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Ayurveda and Anxiety: How Body Constitution Impacts Stress Before Orthopedic Surgery |
|
Scientific Title of Study
|
Evaluation of the association between the levels of stress in pre-operative orthopedic patients and their 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 Vraj Vihari Mishra |
| Designation |
PG Scholar |
| Affiliation |
Dr D.Y. Patil College of Ayurveda and Research Centre Pimpri Pune |
| Address |
Department of Kriya Sharir, Dr D.Y. Patil College of Ayurveda and Research Centre Pimpri Pune Maharashtra India
Pune
MAHARASHTRA
411018
India |
| Phone |
8527706967 |
| Fax |
|
| Email |
vrajviharimishra09@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dushyant D Patil |
| Designation |
Associate Professor |
| Affiliation |
Dr D.Y. Patil College of Ayurveda and Research Centre Pimpri Pune |
| Address |
Department of Kriya Sharir, Dr D.Y. Patil College of Ayurveda and Research Centre Pimpri Pune Maharashtra India
Pune
MAHARASHTRA
411018
India |
| Phone |
9970348007 |
| Fax |
|
| Email |
Dushyant.patil@dpu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dushyant D Patil |
| Designation |
Associate Professor |
| Affiliation |
Dr D.Y. Patil College of Ayurveda and Research Centre Pimpri Pune |
| Address |
Department of Kriya Sharir, Dr D.Y. Patil College of Ayurveda and Research Centre Pimpri Pune Maharashtra India
MAHARASHTRA
411018
India |
| Phone |
9970348007 |
| Fax |
|
| Email |
Dushyant.patil@dpu.edu.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Vraj Vihari Mishra |
| Address |
Department of Kriya Sharir, Dr D.Y. Patil College of Ayurveda and Research Centre Pimpri Pune Maharashtra India |
| Type of Sponsor |
Other [Self] |
|
|
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 Vraj Vihari Mishra |
Dr. D.Y. Patil College of Ayurveda and Research Centre Pimpri Pune Maharashtra India 411018 |
Department of Kriya Sharir, Dr D.Y. Patil College of Ayurveda and Research Centre Pimpri Pune Maharashtra India 411018
Pune
MAHARASHTRA |
8527706967
vrajviharimishra09@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr. DYPCARC Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F439||Reaction to severe stress, unspecified. Ayurveda Condition: CITTAVIBRAMA-SANNIPATAJAJVARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Lifestyle | - | - | Dinacarya: NIL, Ritucarya: NIL, Acara Rasayana:NIL, Other:NIL, Pathya/Apathya:, Pathya:, Apathya: | | 2 | Comparator Arm | Lifestyle | - | - | Dinacarya: NIL, Ritucarya: NIL, Acara Rasayana:NIL, Other:NIL, Pathya/Apathya:, Pathya:, Apathya: |
|
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing Total Knee and Hip replacement within 3 days prior to surgery will be considered. |
|
| ExclusionCriteria |
| Details |
Patients undergoing any kind of psychiatry treatment. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Prakriti identification before surgery can give an idea of what amount of stress levels the individual may
face according to his/her Prakriti and hence appropriate preventive measures can be taken based on this
data to avoid complications during and after the surgery. |
1 day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
01/07/2025 |
| 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="2"
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
|
Following approval from the institutional scientific and ethics committees, patients meeting the inclusion criteria will be selected. Written informed consent will be obtained. Each patient’s Prakriti (body constitution) will be assessed using a standardized questionnaire. Stress levels will be evaluated using the Perceived Stress Scale before surgery. The relationship between patients’ Prakriti and their stress levels will be analyzed using appropriate statistical methods. The collected data will then be analyzed, and conclusions will be drawn based on the results. |