| CTRI Number |
CTRI/2023/11/059733 [Registered on: 09/11/2023] Trial Registered Prospectively |
| Last Modified On: |
06/11/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Acupuncture for Hypertension |
|
Scientific Title of Study
|
Effect of selective acupuncture points on blood pressure 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 S Mohanamathiyal |
| Designation |
PG Scholar |
| Affiliation |
International Institute of Yoga and Naturopathy Medical sciences, Chengalpattu |
| Address |
184/4 , International Institute of Yoga and Naturopathy Medical sciences, Department of Acupuncture and Energy medicine, Faculty block ( first floor),PG class room no.3 Kamarajar nagar , Chengalpattu
Kancheepuram
TAMIL NADU
603001
India |
| Phone |
8940796944 |
| Fax |
|
| Email |
mohanamathiyal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr N Prabu |
| Designation |
Assistant Medical Officer/ Grade 2 Lecturer |
| Affiliation |
International Institute of Yoga and Naturopathy Medical sciences, Chengalpattu |
| Address |
184/4 , International Institute of Yoga and Naturopathy Medical sciences,Department of Acupuncture and Energy medicine, Faculty block ( first floor),PG class room no 3, Kamarajar nagar , Chengalpattu
Kancheepuram
TAMIL NADU
603001
India |
| Phone |
9566351891 |
| Fax |
|
| Email |
drprabubnys91@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr S Mohanamathiyal |
| Designation |
PG Scholar |
| Affiliation |
International Institute of Yoga and Naturopathy Medical sciences, Chengalpattu |
| Address |
184/4 , International Institute of Yoga and Naturopathy Medical sciences,Department of Acupuncture and Energy medicine, Faculty block ( first floor),PG class room no 3 Kamarajar nagar , Chengalpattu
Kancheepuram
TAMIL NADU
603001
India |
| Phone |
8940796944 |
| Fax |
|
| Email |
mohanamathiyal@gmail.com |
|
|
Source of Monetary or Material Support
|
| International Institute of Yoga and Naturopathy Medical Sciences |
|
|
Primary Sponsor
|
| Name |
Dr. S.Mohanamathiyal |
| Address |
184/4 , International Institute of Yoga and Naturopathy Medical Sciences , Chengalpattu , Faculty block (first floor) , Department of Acupuncture and Energy Medicine , Kamarajar Nagar , Chengalpattu - 603001 |
| 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 S Mohanamathiyal |
International Institute of Yoga and Naturopathy Medical sciences |
184/4 ,Department of Acupuncture and Energy medicine, Faculty block ( first floor),PG class room no 3 Kamarajar nagar , Chengalpattu
Kancheepuram
TAMIL NADU |
8940796944
mohanamathiyal@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 |
| Patients |
(1) ICD-10 Condition: I10||Essential (primary) hypertension, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Acupuncture |
Acupuncture needling on SP10,KI3,LU9,LIV2 for 20 minutes once a day, thrice a week, for 6 weeks |
| Comparator Agent |
Rest in normal sitting |
Subjects will be asked to sit normally without Acupuncture for 20 minutes |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Both male and female of age group 35 to 60 year who are under single drug or two drug combination having Blood pressure range between (systolic 140-159mm Hg) and (diastolic 90-99 mmHg) and who are willing to participate in study are included. |
|
| ExclusionCriteria |
| Details |
Participants with Secondary Hypertension , Female participants during menstruation, pregnancy and lactation, Participants with mental illness , Needle phobia are 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 |
Systolic blood pressure (SBP) and Diastolic blood pressure (DBP) will be measured before and after the
intervention using non-invasive Fully Automatic Digital Blood Pressure |
base line and 6th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Heart rate variability will be measured before and after intervention |
Base line & 6th week |
|
|
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)
|
20/11/2023 |
| 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 20-11-2023 and end date provided 21-12-2024?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil2
|
|
Brief Summary
|
Hypertension is known as high or raised blood pressure, is a condition in which the blood vessels have persistently raised pressure when systolic blood pressure (SBP) is ≥140 mmHg and/or the diastolic blood pressure (DBP) is ≥90 mmHg. The number of adults with hypertension in worldwide is predicted to reach 1.56 billion as prevalence by 2025.Acupuncture was one of the earliest and traditional methods of treatment for "hard pulse disease" (now called hypertension). This Randomized controlled trial study aims to evaluate the effect of selective acupuncture points on blood pressure in patients with primary hypertension .This study includes totally 60 participants both male and female. After obtaining informed consent, participants who fit to the inclusion criteria will be randomly allocated into GROUP A (study group ,n=30) GROUP B (control group, n=30) .GROUP A will receive selective acupuncture points at KI3, LIV2, SP10, LU9, alternate sides for 20 minutes once a day for 6 weeks (weekly thrice) along with their regular allopathic medications. GROUP B will be asked to sit for 20 minutes along with their regular allopathic medications. Assessment will be taken before and after the intervention. As a primary outcome the Systolic blood pressure (SBP) and Diastolic blood pressure (DBP) will be measured before and after the intervention using non-invasive Fully Automatic Digital Blood Pressure Monitor. As a secondary outcome Heart rate variability will be measured before and after the intervention of 6 weeks. |