| CTRI Number |
CTRI/2024/02/062926 [Registered on: 20/02/2024] Trial Registered Prospectively |
| Last Modified On: |
09/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
Effect of exercise and diet on reducing Blood Pressure |
|
Scientific Title of Study
|
Role of early lifestyle modification on the Blood Pressure levels of Adolescents with Pre-Hypertension and stage 1 Hypertension in Hubballi taluk, Karnataka state- An Interventional study. |
| 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 Kousar M Mundargi |
| Designation |
Postgraduate |
| Affiliation |
Karnataka Institute of Medical Sciences |
| Address |
Department of Community Medicine, Karnataka Institute of Medical Sciences, Vidya Nagar, Hubballi
Karnataka Institute of Medical sciences, Vidya Nagar, Hubballi
Dharwad
KARNATAKA
580021
India |
| Phone |
991619076 |
| Fax |
|
| Email |
kousarmundargi96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Maneesha Godbole |
| Designation |
Professor |
| Affiliation |
Karnataka Institute of Medical Sciences |
| Address |
Department of Community Medicine, Karnataka Institute of Medical Sciences, Vidya Nagar, Hubballi
Karnataka Institute of Medical sciences, Vidya Nagar, Hubballi
Dharwad
KARNATAKA
580021
India |
| Phone |
9243265798 |
| Fax |
|
| Email |
maneeshag65@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Maneesha Godbole |
| Designation |
Professor |
| Affiliation |
Karnataka Institute of Medical Sciences |
| Address |
Department of Community Medicine, Karnataka Institute of Medical Sciences, Vidya Nagar, Hubballi
Karnataka Institute of Medical sciences, Vidya Nagar, Hubballi
Dharwad
KARNATAKA
580021
India |
| Phone |
9243265798 |
| Fax |
|
| Email |
maneeshag65@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Community Medicine, 3rd floor, Karnataka Institute Of Medical Sciences, Vidyanagar, Hubballi. 580021 |
|
|
Primary Sponsor
|
| Name |
Dr Kousar M Mundargi |
| Address |
postgraduate, department of community medicine
Karnataka Institute of Medical Sciences |
| 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 Maneesha Godbole |
Department of Community Medicine |
3rd floor, Karnataka institute of Medical sciences, college building, Vidyanagar, Hubballi. 580021
Dharwad
KARNATAKA |
9243265798
maneeshag65@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| karnataka institute of medical sciences 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 |
| Comparator Agent |
general advice on healthy lifestyle. |
general advice on diet and physical activity. |
| Intervention |
Yoga, Dietary restrictions, Mudra |
Specific asana(guided shavasana-10 minutes/day) Shankha Mudra(5-10mins twice a day), clapping(cupped hand clapping 12 times), Anulom vilom pranayama(10 cycles) |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
1. Adolescents with pre-hypertension and stage 1 hypertension.
2. Willing to participate in the study. |
|
| ExclusionCriteria |
| Details |
1.Adolescents on treatment for hypertension
2.Adolescents with any other pathological condition |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction of Blood Pressure |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to imbibe healthy lifestyle in the youth of our taluk |
6 months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 3 |
|
Date of First Enrollment (India)
|
26/02/2024 |
| 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="0"
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
|
Pre-Hypertension and Stage 1 Hypertension constitutes an important Public health problem, and Hypertension in adolescents is of growing concern, as they constitute 1/5th of the population of India. Studies have shown that life style modification and non-pharmacological intervention have shown to reduce BP, hence we undertook this cluster Randomized Controlled Trial to estimate the reduction of Blood pressure after an effective life style modification. The study will be conducted in the pre-university college students of age group 16-18 years, with pre hypertension and stage 1 hypertension, over a duration of 6 months, after informed assent, 50 participants in intervention group will be given intervention in the form of pranayama, shavasana, mudras and regular exercises along with consumption of healthy diet and control group will not be give any specific intervention, and follow up will be done. Blood pressure reading at the time of recruitment, after 3 months and 6 months at the completion of trials will be taken, and the results will be analysed using appropriate statistical tests. |