| CTRI Number |
CTRI/2025/01/079276 [Registered on: 23/01/2025] Trial Registered Prospectively |
| Last Modified On: |
23/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Does Cold Weather effect our Heart Health of young healthy individuals
outcome it may effect the heart health and may cause cardiac disorder.
outcome |
|
Scientific Title of Study
|
Effect on Heart Rate Variability and Arterial Blood Pressure in different Ritu on young adult population w.s.r. to Dehik Prakriti an observational study. |
| 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 Lokesh |
| Designation |
lecturer |
| Affiliation |
Institute for Ayurved studies and Research , Shri Krishna Ayush University Kurukshetra |
| Address |
Guru Nanak Ayurvedic Medical College and Research Institute
Gopalpur Department Kriya Sharir
Ayurvedic division Cabin no 8
Ludhiana
PUNJAB
141118
India |
| Phone |
7289900425 |
| Fax |
|
| Email |
drlucky341@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Devendra Khurana |
| Designation |
Proffesor |
| Affiliation |
Institute for Ayurved Studies And Research , Shri Krishna Ayush University |
| Address |
Principal
Institute for Ayurved Studies And Research, Shri Krishna Ayush University ,Umri road , sector 8 , Kurukshetra
Kurukshetra
HARYANA
136118
India |
| Phone |
9416337325 |
| Fax |
|
| Email |
dr.devendrakhurana@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Devendra Khurana |
| Designation |
Proffesor |
| Affiliation |
Institute for Ayurved Studies And Research , Shri Krishna Ayush University |
| Address |
Principal
Institute for Ayurved Studies And Research, Shri Krishna Ayush University ,Umri road , sector 8 , Kurukshetra
Kurukshetra
HARYANA
136118
India |
| Phone |
9416337325 |
| Fax |
|
| Email |
dr.devendrakhurana@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute For Ayurved Studies and Research Shri Krishna Ayush University Kurukshetra Haryana Pin code 136118 India |
|
|
Primary Sponsor
|
| Name |
Dr. Lokesh |
| Address |
Village Kharak khurd Post office Kharak kalan district Bhiwani haryana 127114 |
| 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 Lokesh |
Guru Nanak Ayurvedic Medical College And Research Institute |
Guru Nanak Dev Ayurvedic Medical College And Research Institute Gopalpur pin code 141118 punjab
Department Kriya Sharir Ayurveda Division Cabin no 8
Ludhiana
PUNJAB |
7289900425
drlucky341@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Shri Krishna Ayush University Kurukshetra |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
young adult population
|
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Aged between 18 to 30 years
both male and female subjects
subject with BMI from 18.5 to 24.9
clinically healthy young individuals |
|
| ExclusionCriteria |
| Details |
Smoking
Alcoholism
neurological disorders
Dyslipidemia
Anxiety
Bronchial Asthma
|
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Heart Rate Variability and Blood Pressure influence by different seasons in different Dehik Prakriti individuals |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Electrophysiology of heart is different in different prakriti individuals. |
3 months |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
15/02/2025 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Observational cohort prospective single arm study comparing the Heart Rate Variability and Arterial Blood Pressure with the help of ECG in three different seasons with sample size of 200 individuals who will participate in the study will be young and healthy adults. The HRV and blood pressure is periodically examined in three seasons Season 1: Shishira Ritu (Jan- Feb ) Season 2 : Greeshama Ritu ( may - June) , Season 3 : Sharad Ritu ( sept - october). After that final result will be compared to assess any change in their HRV and Blood Pressure according to seasons. |