| CTRI Number |
CTRI/2024/07/070619 [Registered on: 15/07/2024] Trial Registered Prospectively |
| Last Modified On: |
30/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of electro-acupuncture on heart function in primary hypertension |
|
Scientific Title of Study
|
Immediate effect of electro-acupuncture on heart rate variability in patients with primary hypertension-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 Bharath M |
| Designation |
Post graduate student |
| Affiliation |
Maharishi Aurobindo Subharti College and Hospital of Naturopathy and Yogic Sciences |
| Address |
Department of Post Graduate Studies Subharti College and Hospital of Naturopathy and Yogic Sciences Swami Vivekanand Subharti
University, Subhartipuram Meerut, UTTAR PRADESH, India
Meerut
UTTAR PRADESH
250005
India |
| Phone |
8971162250 |
| Fax |
|
| Email |
bharathmanjunath0217@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR NAIR DHIREN AJIT |
| Designation |
Assistant Professor and Post Graduate (PG) coordinator |
| Affiliation |
Maharishi Aurobindo Subharti College and Hospital of Naturopathy and Yogic Sciences |
| Address |
Department of Post Graduate Studies Subharti College and Hospital of Naturopathy and Yogic Sciences Swami Vivekanand Subharti
University, Subhartipuram Meerut, UTTAR PRADESH, India
Meerut
UTTAR PRADESH
250005
India |
| Phone |
7899143619 |
| Fax |
|
| Email |
danny.a.nair@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abhay M Shankaregowda |
| Designation |
Principal and Dean |
| Affiliation |
Maharishi Aurobindo Subharti College and Hospital of Naturopathy and Yogic Sciences |
| Address |
Department of Post Graduate Studies Subharti College and Hospital of Naturopathy and Yogic Sciences Swami Vivekanand Subharti
University, Subhartipuram Meerut, UTTAR PRADESH, India
Meerut
UTTAR PRADESH
250005
India |
| Phone |
9639010531 |
| Fax |
|
| Email |
naturopathy@subharti.org |
|
|
Source of Monetary or Material Support
|
| Naturopathy and Yoga IPD of Maharishi Aurobindo Subharti College and Hospital of Naturopathy
and Yogic Science and Cardiology Department of the (CSSH) in Meerut, Uttar Pradesh, India-250005 |
|
|
Primary Sponsor
|
| Name |
Dr Bharath M |
| Address |
Maharishi Aurobindo Subharti College and Hospital of Naturopathy
and Yogic Sciences Swami Vivekanand Subharti University
Subhartipuram NH-58 Delhi Haridwar Bypass Road Uttar Pradesh
250005 |
| 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 Bharath M |
Maharishi Aurobindo Subharti College and Hospital of Naturopathy and Yogic Sciences |
Department of Naturopathy and yogic sciences, Department of cardiology
Meerut
UTTAR PRADESH |
8971162250
bharathmanjunath0217@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| University Ethics Committee (Medical) swami vivekanand subharti university |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I10||Essential (primary) hypertension, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Electro-acupuncture for 20 minutes |
The individual will be asked to be in lying down position. Cotton will be used to wipe off required points using spirit (70% alcohol). Acupuncture will be administered to specific locations such as: Pericardium 5 and 6, Stomach 36 and 37, Liver 3 and 8.
on these points electroacupuncture will be given using an electroacupuncture stimulator
Intervention is given for 20 minutes. |
| Comparator Agent |
Manual acupuncture for 20 minutes |
the acupuncture will be given at Pericardium 5 and 6, Stomach 36 and 37, Liver 3 and 8e and the manual stimulation of flicking movement will be given for 20 minutes |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
64.00 Year(s) |
| Gender |
Both |
| Details |
Not received acupuncture or Chinese herbal medicine treatment in the previous 6 months.
Willingness to participate in this study and provide written conformed consents.
Patient with primary hypertension.
Patient who are under prescribed use of anti-hypertensive drugs.
|
|
| ExclusionCriteria |
| Details |
Pregnant women.
Individuals who are unable to give response due to serious physical or mental illness.
Individual with any other co morbidity.
Skin diseases and severe skin damage near the acupoints.
With history of epilepsy.
Patient with a cardiac pacemaker, metal allergy. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Heart rate variability (HRV)
Frequency domain: Low-Frequency band (LF), High Frequency (HF) band and LF/HF ratio.
Time domain: the mean R-R interval, RMSSD, NN50, pNN50 |
Baseline and post |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Blood Pressure, Pulse rate, MAP (Mean arterial pressure), Heart rate |
Baseline and post |
|
|
Target Sample Size
|
Total Sample Size="130"
Sample Size from India="130"
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)
|
26/07/2024 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
A study to find the immediate effect of Electro acupuncture on heart rate variability compared with manual stimulation and to test the hypothesis of electro acupuncture in patients with primary hypertension |