| CTRI Number |
CTRI/2025/02/080468 [Registered on: 13/02/2025] Trial Registered Prospectively |
| Last Modified On: |
30/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
To check the effectiveness of OM Chanting in Stress Induced Hypertension |
|
Scientific Title of Study
|
Study to evaluate add on effectiveness of OM CHANTING among the Stress Induced Hypertensive subjects |
| 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 Shivaraj Subhas Tirlapur |
| Designation |
PG Scholar Department of Swasthavritta |
| Affiliation |
SDM College of Ayurveda and Hospital Hassan |
| Address |
Department of Swasthavritta Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital BM Road Thanniruhalla Hassan 573201 Karnataka
Hassan
KARNATAKA
573201
India |
| Phone |
9513051509 |
| Fax |
|
| Email |
shivarajtirlapur1234@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gurubasavaraj Yalagachin |
| Designation |
Associate Professor Department of Swasthavritta |
| Affiliation |
SDM College of Ayurveda and Hospital Hassan |
| Address |
Department of Swasthavritta Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital BM Road Thanniruhalla Hassan 573201 Karnataka
Hassan
KARNATAKA
573201
India |
| Phone |
9964620229 |
| Fax |
|
| Email |
yogaayu.guru@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gurubasavaraj Yalagachin |
| Designation |
Associate Professor Department of Swasthavritta |
| Affiliation |
SDM College of Ayurveda and Hospital Hassan |
| Address |
Department of Swasthavritta Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital BM Road Thanniruhalla Hassan 573201 Karnataka
Hassan
KARNATAKA
573201
India |
| Phone |
9964620229 |
| Fax |
|
| Email |
yogaayu.guru@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Hassan Thanneeruhalla BM road Hassan Karnataka India 573201 |
|
|
Primary Sponsor
|
| Name |
SDM College of Ayurveda and Hospital |
| Address |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital BM Road Thanniruhalla Hassan 573201 Karnataka |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| SDM COLLEGE OF AYURVEDA AND HOSPITAL TANNERHALLA BM ROAD HASSAN |
SDM COLLEGE OF AYURVEDA AND HOSPITAL TANNERHALLA BM ROAD HASSAN |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shivaraj Subhas Tirlapur |
SDM COLLEGE OF AYURVEDA AND HOSPITAL TANNERHALLA BM ROAD HASSAN |
Department of Swasthavritta Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital BM Road Thanniruhalla Hassan 573201 Karnataka
Hassan
KARNATAKA |
9513051509
shivarajtirlapur1234@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Hassan |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Stress induced Hypertension |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | Om Chanting | (Procedure Reference: Patanjali Yogasutra, Procedure details: Om chanting for 20 minutes in a day in the morning & evening)
| | 2 | Comparator Arm (Non Ayurveda) | | - | Allopathic Hypertensive Medications | Hypertensive medication the subjects are taking |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Age group 30-60 years
2. Stress induced Hypertensive subjects falling under mild to severe stress status in PSS scale
3. Gender- All
4. Ready to sign informed consent form
5. Under Allopathic medication for Hypertension
6. Without any cardiac and neurological complication
|
|
| ExclusionCriteria |
| Details |
1. Non stress induced Hypertensive subjects
2. Pregnant and lactating women
3. Severe Hypertensive subjects
4. Subjects with uncontrolled DM, IHD, CKD and Obesity |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To ruleout stress induced Hypertensive subjects and impact of OM chanting among stress induced Hypertension |
With in 4 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Impact of OM chanting among the stress induced Hypertensive subjects |
With in 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
01/03/2025 |
| 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="6"
Days="0" |
|
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 - NO
|
|
Brief Summary
|
Study title is " Study to evaluate Add on effectiveness of OM chanting among the stress induced Hypertensive subjects " is an observational study to asses the effectiveness of OM chanting in the stress induced Hypertensive subjects between the age group of 30-60 years without any complications like uncontrolled DM, IHD. Sample size of 40 subjects divided to 2 groups and study duration of 1 and half year. The data collecting method is by case report form. Data will be collected in both English and regional languages and data analysis will be done with the help of SPSS software. |