| CTRI Number |
CTRI/2021/03/031788 [Registered on: 08/03/2021] Trial Registered Prospectively |
| Last Modified On: |
10/02/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Relationship between Food and Mental Health |
|
Scientific Title of Study
|
A cross sectional survey study on relationship between Trigunatmak (Satvik, Rajsik, Tamsik) Ahara and Mental health |
| Trial Acronym |
RTAMH |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Yaman Kumar Sharma |
| Designation |
MD Scholar |
| Affiliation |
All India Institute of Ayurveda |
| Address |
Room No 720 Dept of Samhita and Siddhant Academic block All India Institute of Ayurveda Mathura road Gautam Puri Sarita Vihar New Delhi 110076
All India Institute of Ayurveda
Mathura Road Gautam Puri Sarita Vihar New Delhi 110076
South
DELHI
110076
India |
| Phone |
7838067672 |
| Fax |
|
| Email |
dakshinavartiyaman@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pankaj Pathak |
| Designation |
Associate Professor Dept of Samhita and Siddhant |
| Affiliation |
All India Institute of Ayurveda |
| Address |
Room No 719 Dept of Samhita and Siddhant Academic block All India Institute of Ayurveda Mathura road Gautam Puri Sarita Vihar New Delhi 110076
All India Institute of Ayurveda
Mathura Road Gautam Puri Sarita Vihar New Delhi 110076
South
DELHI
110076
India |
| Phone |
9737491078 |
| Fax |
|
| Email |
pankajayur07@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Yaman Kumar Sharma |
| Designation |
M.D Scholar |
| Affiliation |
All India Institute of Ayurveda |
| Address |
Room No 720 Dept of Samhita and Siddhant Academic block All India Institute of Ayurveda Mathura road Gautam Puri Sarita Vihar New Delhi 110076
All India Institute of Ayurveda
Mathura Road Gautam Puri Sarita Vihar New Delhi 110076
South
DELHI
110076
India |
| Phone |
7838067672 |
| Fax |
|
| Email |
dakshinavartiyaman@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute Of Ayurveda |
|
|
Primary Sponsor
|
| Name |
All India Institute of Ayurveda |
| Address |
All India Institute of Ayurveda Mathura Road Gautam Puri Sarita Vihar New Delhi 110076 |
| 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 Yaman Kumar Sharma |
All India Institute of Ayurveda |
Opd no 7 Ground Floor Hospital Block All India Institute of Ayurveda
South
DELHI |
7838067672
dakshinavartiyaman@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 |
Healthy subjects of age group of 20 to 50 years will be included |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1 Healthy subjects of age group of 20-50 years will be included.
2 Healthy subjects irrespective to their caste religion gender will be taken
3 Prior informed written consent will be taken |
|
| ExclusionCriteria |
| Details |
1 Congenital diseases
2 Hereditary diseases
3 Mental illness
4 Neurological disorders
5 other co-morbidities |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the relation between Trigunatmak Ahara and Mental health of individual |
25 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the relation of Trigunatmak Ahara and Manas Prakriti |
15 days |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
09/09/2021 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
1. SURVEY STUDY: A survey study will be conducted on healthy individuals fulfilling the criteria of selection. 2. SURVEY TOOL: This is a survey based research study. This research will involve two different validated proformas, that include assessment of food of participants on the basis of Triguna (Satvik, Rajsik and Tamsik) and Mental health.
|