| CTRI Number |
CTRI/2025/11/097992 [Registered on: 24/11/2025] Trial Registered Prospectively |
| Last Modified On: |
23/11/2025 |
| 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 acupuncture needling on heart function and blood pressure in patients with high Blood Pressure |
|
Scientific Title of Study
|
Effect of acupuncture at UB15 and CV14 on Heart Rate Variability and Blood Pressure in patients with 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 T Sabari |
| Designation |
PG Scholar |
| Affiliation |
Government Yoga and Naturopathy Medical College and Hospital, Arumbakkam, Chennai |
| Address |
Department of Acupuncture and Energy Medicine, Second floor,
PG block, Government Yoga and Naturopathy Medical College and Hospital, Arumbakkam, Chennai
Chennai
TAMIL NADU
600106
India |
| Phone |
8838026296 |
| Fax |
|
| Email |
sabaribnys6@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr A Mooventhan |
| Designation |
Assistant Medical Officer cum Lecturer grade 2 |
| Affiliation |
Government Yoga and Naturopathy Medical College and Hospital, Arumbakkam, Chennai |
| Address |
Government Yoga and Naturopathy Medical College and Hospital
Department of Research, Second floor, Government Yoga and Naturopathy Medical College and Hospital, PG block, Arumbakkam, chennai
Chennai
TAMIL NADU
600106
India |
| Phone |
9844457496 |
| Fax |
|
| Email |
dr.mooventhan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr A Mooventhan |
| Designation |
Assistant Medical Officer cum Lecturer grade 2 |
| Affiliation |
Government Yoga and Naturopathy Medical College and Hospital, Arumbakkam, Chennai |
| Address |
Government Yoga and Naturopathy Medical College and Hospital
Department of Research, Second floor, Government Yoga and Naturopathy Medical College and Hospital, PG block, Arumbakkam, chennai
Chennai
TAMIL NADU
600106
India |
| Phone |
9844457496 |
| Fax |
|
| Email |
dr.mooventhan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Yoga and Naturopathy Medical College and Hospital, Arignar Anna Indian Medicine Campus Arumbakkam, Chennai- 106 |
|
|
Primary Sponsor
|
| Name |
Government Yoga and Naturopathy Medical college and hospital |
| Address |
Government Yoga and Naturopathy Medical College and Hospital, Arumbakkam, chennai-106 |
| 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 |
| Dr T Sabari |
Government Yoga and Naturopathy Medical College and Hospital, Arumbakkam, Chennai |
Government Yoga and Naturopathy Medical College and Hospital
Department of Acupuncture and Energy medicine, Second floor, PG block, Arumbakkam, chennai
Chennai
TAMIL NADU |
8838026296
sabaribnys6@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government Yoga and Naturopathy Medical college and hospital, Chennai, Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I00-I99||Diseases of the circulatory system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Acupuncture at UB15 and CV14 |
Acupuncture points UB15(Bilateral) and CV14(Unilateral) will be located. After that, Acupuncture needles will be inserted based on Shu- Mu method of needling (Needling at Back Shu point first, followed by needling at Mu front point).
The needles will be retained for duration of 30 minutes. The intervention will be given for 7 days a week for 2 weeks. |
| Comparator Agent |
No intervention will be given |
Participants will be on their daily normal routine |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed with hypertension according to standard clinical guidelines of European Society of Hypertension.
Willing to participate and provide informed consent
|
|
| ExclusionCriteria |
| Details |
Patients with acute and chronic glomerulonephritis, renal artery stenosis, chronic kidney disease, pheochromocytoma, primary aldosteronism, etc.
Patients suffering from contagious diseases and other malignant diseases
Women in pregnancy or lactation
Patients with breakage, inflammation, scarring, etc, at the selected acupuncture point.
Patients with serious cardiac arrhythmia, recent myocardial infarction, recent episode of stroke, or heart failure.
History of psychosis or any other mental or intellectual abnormalities.
Patients with acupuncture needle phobia.
Participation in any other clinical trials.
|
|
|
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 (HRV) |
Heart Rate Variability (HRV) will be taken before and after intervention on day1 and on day14 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Systolic Blood Pressure (SBP)
Diastolic Blood Pressure (DBP)
Mean Arterial Pressure (MAP)
Pulse Pressure (PP) |
Systolic Blood Pressure (SBP),
Diastolic Blood Pressure (DBP), Mean Arterial Pressure (MAP), Pulse Pressure (PP).
All these outcome measures will be taken at baseline (Day 1 - before & after intervention) & after two weeks (Day 14 - before & after intervention) |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
26/12/2025 |
| 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="5"
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
|
A randomized controlled trial will be adopted for the study. All the eligible subjects (n = 60) will be randomly divided into a study group (n = 30) and a control group (n = 30). The study group will undergo needling at acupuncture points UB15 and CV14 for 30 minutes per session, 7 days per week for 2 weeks. The control group will follow their daily normal routine and will not receive any acupuncture during the course of study. Heart rate variability, Systolic blood pressure, Diastolic blood pressure, Mean arterial pressure and Pulse pressure will be measured before and after intervention on day 1 and on day 14 for both study group and control group. |