| CTRI Number |
CTRI/2025/02/081145 [Registered on: 21/02/2025] Trial Registered Prospectively |
| Last Modified On: |
05/02/2025 |
| 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
|
ear acupuncture and healthy individuals and heart rate variability |
|
Scientific Title of Study
|
Evaluating the Immediate Impact of Auricular Acupuncture at the Heart Point on Heart Rate Variability Among Healthy Population– 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 JAHEER HUSSAIN A |
| Designation |
PG SCHOLAR |
| Affiliation |
INTERNATIONAL INSTITUTE OF YOGA AND NATUROPATHY MEDICAL SCIENCES |
| Address |
184/4 International Institute of Yoga and Naturopathy Medical
Sciences, Faculty Block, First Floor, Kamarajar Nagar, Chengalpattu.
184/4 International Institute of Yoga and Naturopathy Medical
Sciences, Faculty Block, First Floor, Kamarajar Nagar, Chengalpattu.
Kancheepuram
TAMIL NADU
603001
India |
| Phone |
6381039300 |
| Fax |
|
| Email |
acjaheer97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR GEETHANJALI S |
| Designation |
Assistant Medical Officer / Lecturer Grade II |
| Affiliation |
INTERNATIONAL INSTITUTE OF YOGA AND NATUROPATHY MEDICAL SCIENCES |
| Address |
184/4 International Institute of Yoga and Naturopathy Medical
Sciences, Faculty Block, First Floor, Kamarajar Nagar, Chengalpattu.
184/4 International Institute of Yoga and Naturopathy Medical
Sciences, Faculty Block, First Floor, Kamarajar Nagar, Chengalpattu.
Kancheepuram
TAMIL NADU
603001
India |
| Phone |
6381039300 |
| Fax |
|
| Email |
drgeethu.nat007@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR GEETHANJALI S |
| Designation |
Assistant Medical Officer / Lecturer Grade II |
| Affiliation |
INTERNATIONAL INSTITUTE OF YOGA AND NATUROPATHY MEDICAL SCIENCES |
| Address |
184/4 International Institute of Yoga and Naturopathy Medical
Sciences, Faculty Block, First Floor, Kamarajar Nagar, Chengalpattu
184/4 International Institute of Yoga and Naturopathy Medical
Sciences, Faculty Block, First Floor, Kamarajar Nagar, Chengalpattu
Kancheepuram
TAMIL NADU
603001
India |
| Phone |
6381039300 |
| Fax |
|
| Email |
drgeethu.nat007@gmail.com |
|
|
Source of Monetary or Material Support
|
| 184/4 International Institute of Yoga and Naturopathy Medical Sciences, Chengalpattu-603001. |
|
|
Primary Sponsor
|
| Name |
DR JAHEER HUSSAIN A |
| Address |
184/4 International Institute of Yoga and Naturopathy Medical
Sciences,Faculty Block First Floor,Kamarajar nagar,Chengalpattu. |
| 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 JAHEER HUSSAIN A |
INTERNATIONAL IINSTITUTE OF YOGA AND NATUROPATHY MEDICAL SCIENCES |
184/4 International
Institute of Yoga and
Naturopathy Medical
Sciences, Faculty Block
First Floor, Kamarajar
Nagar, Chengalpattu.
Kancheepuram
TAMIL NADU |
6381039300
acjaheer97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| International Institute of Yoga and Naturopathy Medical Sciences, Chengalpattu , Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ear acupuncture |
The press needles will be given to left ear on the selected auricular point heart point for 20 minutes. |
| Comparator Agent |
sham acupuncture |
Sham acupuncture technique will be applied, as without a needle only plaster is placed as left ear for 20 minutes. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
29.00 Year(s) |
| Gender |
Both |
| Details |
The study will involve healthy men and women between the ages of 18 and 29, with no history of cardiovascular diseases, diabetes, or thyroid disorders. Participants must be willing to voluntarily engage in the research and meet the specified criteria for inclusion.
|
|
| ExclusionCriteria |
| Details |
The study will exclude patients with psychiatric conditions such as schizophrenia or depression. Additionally, individuals who have a fear of needles, known as trypanophobia, and women who are currently menstruating, pregnant, or breastfeeding will not be eligible to participate in the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Heart rate variability |
baseline 20 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| SF-12 Questionnaires |
baseline 20 minutes. |
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
21/02/2025 |
| 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 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
|
This study, a randomized controlled trial, aims to explore the effects of auricular acupuncture on heart rate variability (HRV) and quality of life (QoL). HRV, a key indicator of autonomic nervous system balance, can help assess cardiovascular health and the risk of issues like arrhythmias and sudden cardiac death. Auricular acupuncture, particularly targeting the vagus nerve area in the ear, enhances parasympathetic activity, improving HRV and cardiovascular function. The trial will involve 60 participants, divided into a study group and a control group, with pre- and post-intervention data collected after 20 minutes of acupuncture. Primary outcomes will include HRV and heart rate, while secondary outcomes will focus on QoL, assessed using the SF-12 questionnaire. Participants will be selected using simple random sampling, with inclusion criteria including healthy individuals aged 18-29 without cardiovascular, diabetes, or thyroid disorders. Exclusion criteria include psychiatric conditions, needle phobia, or women who are menstruating, pregnant, or breastfeeding. |