| CTRI Number |
CTRI/2025/02/080095 [Registered on: 07/02/2025] Trial Registered Prospectively |
| Last Modified On: |
28/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Pratiloma Pranayama among healthy individuals for the assessment of Heart Rate Variability(HRV) |
|
Scientific Title of Study
|
Effect of Pratiloma Pranayama on Heart Rate Variability Among Healthy Individuals-A Randomized Controlled Trial |
| 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 S SANTHOSH KUMAR |
| Designation |
PG SCHOLAR |
| Affiliation |
INTERNATIONAL INSTITUTE OF YOGA AND NATUROPATHY MEDICAL SCIENCES |
| Address |
INTERNATIONAL INSTITUTE OF YOGA AND NATUROPATHY MEDICAL SCIENCES KAMARAJAR NAGAR CHENGALPATTU
INTERNATIONAL INSTITUTE OF YOGA AND NATUROPATHY MEDICAL SCIENCES KAMARAJAR NAGAR CHENGALPATTU
Kancheepuram
TAMIL NADU
603001
India |
| Phone |
9080195306 |
| Fax |
|
| Email |
santhoshsanddy1998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR GAYATHRI A |
| Designation |
Head of Department(Yoga) |
| Affiliation |
INTERNATIONAL INSTITUTE OF YOGA AND NATUROPATHY MEDICAL SCIENCES |
| Address |
184/4, INTERNATIONAL INSTITUTE OF YOGA AND NATUROPATHY MEDICAL SCIENCES, FACULTY BLOCK (FIRST FLOOR), DEPARTMENT OF YOGA, KAMARAJAR NAGAR CHENGALPATTU
184/4, INTERNATIONAL INSTITUTE OF YOGA AND NATUROPATHY MEDICAL SCIENCES, FACULTY BLOCK (FIRST FLOOR), DEPARTMENT OF YOGA, KAMARAJAR NAGAR CHENGALPATTU
Kancheepuram
TAMIL NADU
603001
India |
| Phone |
9080195306 |
| Fax |
|
| Email |
santhoshsanddy1998@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR S SANTHOSH KUMAR |
| Designation |
PG SCHOLAR |
| Affiliation |
INTERNATIONAL INSTITUTE OF YOGA AND NATUROPATHY MEDICAL SCIENCES |
| Address |
INTERNATIONAL INSTITUTE OF YOGA AND NATUROPATHY MEDICAL SCIENCES KAMARAJAR NAGAR CHENGALPATTU
INTERNATIONAL INSTITUTE OF YOGA AND NATUROPATHY MEDICAL SCIENCES KAMARAJAR NAGAR CHENGALPATTU
Kancheepuram
TAMIL NADU
603001
India |
| Phone |
9080195306 |
| Fax |
|
| Email |
santhoshsanddy1998@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
DR S SANTHOSH KUMAR |
| Address |
184/4, INTERNATIONAL INSTITUTE OF YOGA AND NATUROPATHY MEDICAL SCIENCES, FACULTY BLOCK (FIRST FLOOR), DEPARTMENT OF YOGA, KAMARAJAR NAGAR CHENGALPATTU |
| Type of Sponsor |
Government medical college |
|
|
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 |
| DRSSANTHOSH KUMAR |
INTERNATIONAL INSTITUTE OF YOGA AND NATUROPATHY MEDICAL SCIENCES |
INTERNATIONAL INSTITUTE OF YOGA AND NATUROPATHY MEDICAL SCIENCES KAMARAJAR NAGAR CHENGALPATTU
INTERNATIONAL INSTITUTE OF YOGA AND NATUROPATHY MEDICAL SCIENCES KAMARAJAR NAGAR CHENGALPATTU
Kancheepuram
TAMIL NADU |
9080195306
santhoshsanddy1998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INTERNATIONAL INSTITUTE OF YOGA AND NATUROPATHY MEDICAL SCIENCES, INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
PARASYMPATHETIC ACTIVATION |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Pratiloma pranayama |
Pratiloma pranayama 20 minutes daily for 21 days |
| Comparator Agent |
Relax in sitting position |
Patient will concentrate on breathing for 20 minutes daily for 21 days without any intervention. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
Healthy male and female participants aged 18–35 years, with no history of systemic illness, were included after obtaining their consent. |
|
| ExclusionCriteria |
| Details |
Participants with medical, psychiatric, neurological conditions, surgical history, injuries, refractive errors, pregnancy, lactation, or recent exposure to yoga practices were excluded. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Heart rate variability |
Baseline and 21 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Blood pressure |
Baseline and 21 days |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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
|
Phase 1 |
|
Date of First Enrollment (India)
|
10/02/2025 |
| 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="1"
Days="1" |
|
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) - ONLINE
- For how long will this data be available start date provided 08-01-2025 and end date provided 09-01-2026?
Response (Others) - 1 YEAR
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Pranayama is a yogic breathing practice that refers to controlling the life force or extension of breathing pattern. pratiloma pranayama plays a significant role in regulating the cardiac autonomic function.During deep inspiration, vagal activity decreases, increasing heart rate. During expiration, vagal activity restores, slowing heart rate. This variation is measured as the expiratory:inspiratory ratio using R-R intervals and it’s parameter’s such as the Heart rate variability.All theeligible study participants will be divided into two groups, Study group and control group by simple randomization.Participants will be randomly divided (1:1 ratio) into study and control groups using simple random methods with the use of computerized randomization.inclusion criteria with 18 – 35 years Gender – Both male and female Healthy participant with their consent Not having any previous systemic illness.The study group will receive five rounds of Pratiloma pranayama for 20 minutes. While the control group will be at rest in sitting position for 20 minutes per day for a period of 21days.Control group will be advised to concentrate on their breathing in sitting position for 20 min for the 21 days.primary outcome of HRV will be assesed on baseline and 21 days.secondary outcome of blood pressure will be assesed on baseline and 21 days. |