| CTRI Number |
CTRI/2025/02/080297 [Registered on: 10/02/2025] Trial Registered Prospectively |
| Last Modified On: |
08/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
To observe if the results of autonomic function tests vary according to the prakriti of an individual |
|
Scientific Title of Study
|
An observational study to assess variations in the autonomic response in healty volunteers of different constitutional types |
| 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 Bhavika |
| Designation |
MD Scholar Department of Kriya Sharir |
| Affiliation |
Institute for Ayurved Studies and Research Umri Road Sector 8 Kurukshetra Haryana 136118 |
| Address |
Opd No 55A Department of Kriya Sharir Institute for Ayurved Studiesand Research Umri Road Sector 8 Kurukshetra Haryana
Kurukshetra
HARYANA
136118
India |
| Phone |
9813256946 |
| Fax |
|
| Email |
bhavika.arora946@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manisha Khatri |
| Designation |
Association Professor Department of Kriya Sharir |
| Affiliation |
Institute for Ayurved Studies and Research Umri Road Sector 8 Kurukshetra Haryana 136118 |
| Address |
Room no 10 Department of Kriya Sharir Institute for Ayurved Studiesand Research Umri Road Sector 8 Kurukshetra Haryana 136118 Kurukshetra HARYANA
Kurukshetra
HARYANA
136118
India |
| Phone |
9416482897 |
| Fax |
|
| Email |
manikhatri79@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhavika |
| Designation |
MD Scholar Department of Kriya Sharir |
| Affiliation |
Institute for Ayurved Studies and Research Umri Road Sector 8 Kurukshetra Haryana 136118 |
| Address |
Opd No 55A Department of Kriya Sharir Institute for Ayurved Studiesand Research Umri Road Sector 8 Kurukshetra Haryana
Kurukshetra
HARYANA
136118
India |
| Phone |
9813256946 |
| Fax |
|
| Email |
bhavika.arora946@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute for Ayurved Studies and Research Umri Road Sector 8 Kurukshetra Haryana 136118 |
|
|
Primary Sponsor
|
| Name |
Dr Bhavika |
| Address |
Opd No 55A Department of Kriya Sharir Institute for Ayurved Studiesand Research Umri Road Sector 8 Kurukshetra Haryana 136118 |
| 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 Bhavika |
Institute for Ayurved Studies and Research Sector 8 Kurukshetra Haryana |
Opd No 55A Department of Kriya Sharir Institute for Ayurved Studies and Research Umri Road Sector 8 Kurukshetra Haryana 136118
Kurukshetra
HARYANA |
9813256946
bhavika.arora946@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Autonomic Nervous system response |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Patient willing to participate in the trial. Patient with age between 20-30 years. Patient of both male and female sex. |
|
| ExclusionCriteria |
| Details |
K/C/O Diarrhea, Dry mouth, Urinary Incontinence, Diabetes mellitus, hypertension, orthostatic hypotension, hyper or hypothyroidism, CAD, CHD, Autonomic Dysfunction, Sweating Abnormalities. Pregnant women and Lactating mothers. History of any major surgery in the recent past. History of Prolonged medicine intake like Beta blocker, thyroxine. History of Alcohol intake & smoking.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Correlation Between Prakriti and Autonomic Responses:Establishing significant correlations between prakriti types and specific autonomic response patterns (e.g., HRV, blood pressure, stress response). |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 Customized Interventions:Development of personalized health interventions, dietary recommendations, & lifestyle modifications based on prakriti types. Creation of prakriti-specific guidelines for managing stress & enhancing autonomic function
2 Scientific Validation:Empirical validation of Ayurvedic principles, enhancing their credibility & integration into conventional medicine.
3 Enhanced Patient Outcomes:Improved patient outcomes through personalized treatment plans that consider individual constitutional types.Reduced incidence of adverse effects & increased patient adherence to therapeutic regimens.
4 Educational Tools:Increased awareness & understanding of the importance of constitutional types in medical education & practice.
5 Future Research Directions:Exploration of the genetic & molecular basis of prakriti types & their influence on autonomic function. |
60 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
20/02/2025 |
| 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="2" |
|
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
|
Total 60 patients will be enrolled for the study purpose having age group between 20-30 years irrespective of sex, caste, race, religion and socia economic status. Written consent will be taken from the volunteer patients in their easy understandable language. There will be three groups :-Group A(Vata dominant), Group B(Pitta Dominant), Group C( Kapha dominant). The observation and results will be analysed and presented in accordance with the respective and applicable statistical tests. |