| CTRI Number |
CTRI/2024/02/063355 [Registered on: 29/02/2024] Trial Registered Prospectively |
| Last Modified On: |
09/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Yogic Breathing and Relaxation versus Standard Non-Pharmacological Treatment on Blood Pressure. |
|
Scientific Title of Study
|
Efficacy of 12-week practice of Yogic Breathing and Relaxation vs Standard non-pharmacological interventions on Blood Pressure and Lifestyle parameters among Hypertensive adults: A Randomized Control 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 |
Rajat Sharma |
| Designation |
Junior Resident, Department of General Medicine, AIIMS Rishikesh |
| Affiliation |
AIIMS, Rishikesh |
| Address |
Room no. 1078, 2nd Floor, Lifestyle Disease Clinic, Department of General Medicine, AIIMS Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
7536049804 |
| Fax |
|
| Email |
surajdostpuriya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Monika Pathania |
| Designation |
Additional Professor, Department of General Medicine, AIIMS Rishikesh |
| Affiliation |
AIIMS, Rishikesh |
| Address |
Room no. 1078, 2nd Floor, Lifestyle Disease Clinic, Department of General Medicine, AIIMS Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
8126021556 |
| Fax |
|
| Email |
anshupathania27@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rajat Sharma |
| Designation |
Junior Resident, Department of General Medicine, AIIMS Rishikesh |
| Affiliation |
AIIMS, Rishikesh |
| Address |
Room no. 1078, 2nd Floor, Lifestyle Disease Clinic, Department of General Medicine, AIIMS Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
7536049804 |
| Fax |
|
| Email |
surajdostpuriya@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS RISHIKESH |
| Address |
Room no. 1078, 2nd Floor, Lifestyle Disease Clinic, Department of General Medicine, AIIMS Rishikesh |
| Type of Sponsor |
Other [Self-Funded] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| SELF FUNDED |
Boys Hostel, Building No.77, AIIMS Rishikesh, Virbhadra Road, Rishikesh; Uttarakhand, India; PIN: 249203 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rajat Sharma |
AIIMS Rishikesh |
Room no. 1078, 2nd Floor, Lifestyle Disease Clinic, Department of General Medicine
Dehradun
UTTARANCHAL |
7536049804
surajdostpuriya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| All India Institute of Medical Sciences, Rishikesh, 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 |
Pranayama and Yoga Nidra Meditation |
Breathing exercises and Yoga Nidra Meditation shall be taught to participants on their day of enrollment in the study. Participants shall follow this daily for next 12 weeks at home with in between Follow-ups and reminders via Phone. |
| Comparator Agent |
Standard Non-Pharmacological Treatment like DASH Diet and Brisk Walk |
Participants in Control arm shall be asked to follow DASH diet and do brisk walk FOR 40 minutes (for at least 5 days in a week) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Participants must be 18 years to 55 years of age.
2. Diagnosed with Elevated BP and Stage 1 Hypertension (classified as per AHA/ACC guidelines).
3. Should agree to do regular yoga practice based on yoga module.
|
|
| ExclusionCriteria |
| Details |
1. Practicing Yoga/Meditation for more than 1 month in the previous 6 months.
2. Having Comorbidities like Diabetes Mellitus, Chronic Kidney Disease, Established Cardiovascular Disease, Stroke, Epilepsy, Migraine or Psychiatric Disorder.
3. Not willing to provide written informed consent.
4. Pregnant Women.
5. Less than 75% compliance.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the efficacy of pranayama and meditation in participants with hypertension and compare them with standard non pharmacological treatment for blood pressure reduction. |
All outcomes will be assessed at four time points, i.e., at enrollment, i.e., baseline, after four weeks of baseline, after eight weeks of baseline and final assessment will be conducted after twelve weeks of baseline. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
o Sleep Quality using Pittsburgh Sleep Quality Index (PSQI)
o Perceived stress levels (using Perceived Stress Scale)
o Physical Activity Levels (using Global Physical Activity Questionnaire)
o Alcohol usage (using Alcohol Use Disorder Identification Test)
o Socioeconomic status (using updated KuppuSwamy Socioeconomic Scale)
o Anthropometric Measurements: height (cm), weight (kg), body mass index (kg/m2), hip circumference (cm), waist circumference (cm) and waist to hip ratio.
|
All outcomes will be assessed at four time points, i.e., at enrollment, i.e., baseline, after four weeks of baseline, after eight weeks of baseline and final assessment will be conducted after twelve weeks of baseline. |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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)
|
01/03/2024 |
| 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="1"
Days="1" |
|
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
|
This study shall see the efficacy of Standard Non-Pharmacological interventions like DASH diet, Brisk walk compared to Pranayama and Yoga Nidra Meditation to reduce Blood Pressure and improve other Lifestyle Parameters like Sleep quality, Lipid Profile, change in BMI in Hypertensive adults (18 to 55 years of age). |