| CTRI Number |
CTRI/2025/02/081165 [Registered on: 24/02/2025] Trial Registered Prospectively |
| Last Modified On: |
04/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Observational |
| Study Design |
Other |
|
Public Title of Study
|
Study on the combined effect of lean diet and excessive exercise on heart health among gym goers |
|
Scientific Title of Study
|
An exploratory study to determine the impact of Ruksa Ahara and Ati Vyayama as a risk factor in Vataja Hrdayaroga among gym enthusiasts |
| 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 Amandeep Singh |
| Designation |
PG Scholar |
| Affiliation |
Shri Dhanwantry Ayurvedic College and Hospital |
| Address |
A 204
Department of Samhita and Siddhanta
Shri Dhanwantry Ayurvedic College and Hospital
Sector 46B
Chandigarh
Chandigarh
CHANDIGARH
160047
India |
| Phone |
9780596261 |
| Fax |
|
| Email |
amandeepdhaliwal2222@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Renu Bala |
| Designation |
Associate Professor |
| Affiliation |
Shri Dhanwantry Ayurvedic College and Hospital |
| Address |
A 204
Department of Samhita and Siddhanta
Shri Dhanwantry Ayurvedic College and Hospital
Sector 46B
Chandigarh
Chandigarh
CHANDIGARH
160047
India |
| Phone |
8427009201 |
| Fax |
|
| Email |
doctorrenubala@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amandeep Singh |
| Designation |
PG Scholar |
| Affiliation |
Shri Dhanwantry Ayurvedic College and Hospital |
| Address |
A 204
Department of Samhita and Siddhanta
Shri Dhanwantry Ayurvedic College and Hospital
Sector 46B
Chandigarh
Chandigarh
CHANDIGARH
160047
India |
| Phone |
9780596261 |
| Fax |
|
| Email |
amandeepdhaliwal2222@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD of Shri Dhanwantry Ayurvedic College And Hospital Sector 46B Chandigarh 160047 |
|
|
Primary Sponsor
|
| Name |
Dr Amandeep Singh |
| Address |
A 204
Department of Samhita and Siddhanta
Shri Dhanwantry Ayurvedic College and Hospital Sector 46B Chandigarh 160047 |
| 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 Amandeep Singh |
Shri Dhanwantry Ayurvedic College and Hospital, Sector 46B, Chandigarh |
Department of Samhita and Siddhanta (Basic Principle)
Maharshi Bharadwaj kaksh
Room no A-204 , Academic block
Chandigarh
CHANDIGARH |
9780596261
amandeepdhaliwal2222@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Shri Dhanwantry Ayurvedic College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:I469||Cardiac arrest, cause unspecified. Ayurveda Condition: HRUDROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Gym goers of age 30-50 years of all sexes.
Gym goers who go to gym for at least one year regularly.
Gym goers who are willing to participate in the trial. |
|
| ExclusionCriteria |
| Details |
Gym goers who go to gym less than one year regularly.
Gym goers with history of hypertension and heart condition before joining gym.
Gym goers with other systemic disorders.
Gym goers with any type of psychological condition.
Gym goers who are not willing to participate in the trial. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| An exploratory study to determine the impact of Ruksa Ahara and Ati Vyayama as a risk factor in Vataja Hrdayaroga among gym enthusiasts. |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To explore the concept of Vataja Hrdayaroga.
To explore the concept of Ruksa Ahara.
To explore the concept of Vyayama.
To validate the questionnaire for the assessment of Ruksa Ahara and Ati Vyayama.
To explore the combined effects of Ruksa Ahara and Ati Vyayama as a risk factor in Vataja Hrdayaroga. |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
05/03/2025 |
| 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="6"
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
|
Abstract: In modern era, exercises are considered as best thing you can do to stay healthy and prevent diseases. But in today’s world, there is lot of emphasis placed on body looks, mainly due to the influence of social media and societal standards. Its concerning how young adults engage in unhealthy exercise and dieting practices solely for outer looks and appearance. Acharya Charaka mentioned that eating Ruksa, cold, less & lean diet and following practices like Langhana, swimming, excessive walking, leads to increase of Vata in body. This proliferated Vata then fills the empty spaces(Strotas) in the body which sow the seeds of heart conditions in the body. This research work aims to find out whether Ruksa Ahara and Ati Vyayama together effects the human heart.
Aim: An exploratory study to determine the impact of Ruksa Ahara and Ati Vyayama as a risk factor in Vataja Hrdayaroga among gym enthusiasts.
Objectives: To explore the concept of Vataja Hrdayaroga. To explore the concept of Ruksa Ahara. To explore the concept of Vyayama. To validate the questionnaire for the assessment of Ruksa Ahara and Ati Vyayama. To explore the combined effects of Ruksa Ahara and Ati Vyayama as a risk factor in Vataja Hrdayaroga.
Justification for study: Many gym enthusiasts prioritise consuming protein and limit their fat intake in diet without knowing their harmful effects on body. Additionally, they engage in intense exercise routines. This survey provide valuable insights into whether these practices influence the occurrence of Vataja Hrdayaroga in gym goers. Understanding these connections can help in promoting healthier lifestyle choices and reducing the risk of heart-related issues among individuals who prioritise fitness. |