| CTRI Number |
CTRI/2017/02/007822 [Registered on: 10/02/2017] Trial Registered Retrospectively |
| Last Modified On: |
20/05/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Impact of a structured yoga program on blood pressure reduction among hypertensive patients in Nepal |
|
Scientific Title of Study
|
Impact of a structured yoga program on blood
pressure reduction among hypertensive patients in Nepal |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Raja Ram Dhungana |
| Designation |
Research Director |
| Affiliation |
Nepal Family Development Foundation |
| Address |
Nepal Family Development Foundation, Kathmandu, Nepal
no Other |
| Phone |
9841077291 |
| Fax |
|
| Email |
raja.dhungana@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Raja Ram Dhungana |
| Designation |
Research Director |
| Affiliation |
Nepal Family Development Foundation |
| Address |
Nepal Family Development Foundation, Kathmandu, Nepal
no Other |
| Phone |
9841077291 |
| Fax |
|
| Email |
raja.dhungana@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Raja Ram Dhungana |
| Designation |
Research Director |
| Affiliation |
Nepal Family Development Foundation |
| Address |
Nepal Family Development Foundation, Kathmandu, Nepal
no Other |
| Phone |
9841077291 |
| Fax |
|
| Email |
raja.dhungana@gmail.com |
|
|
Source of Monetary or Material Support
|
| District Ayurveda Health Centers |
|
|
Primary Sponsor
|
| Name |
Nepal Family Development Foundation |
| Address |
Kathmandu,Nepal |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
Nepal |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Raja Ram Dhungana |
District Ayurveda Centers |
Nepal
|
9841077291
raja.dhungana@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Nepal Health Research Council |
Approved |
| Nepal Health research Council |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
The hypertensive persons who have blood pressure: SBP of 130 to 159 mm Hg or DBP of 85 to 99 mm Hg
, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Health Education |
Group counseling session will be organized for control group. It will be for two hours for single time. The course curriculum and contents will be adopted from the health education materials endorsed by National Health Education Information and Communication Center (NHEICC), Ministry of Health and Population, Nepal. It contains behavioural and life style modification education designed to reduce the |
| Intervention |
Yoga and Health Education |
The intervention consists of two components: A five days training of yoga and two hours group counseling for healthy behaviours to hypertensive participants at study site by trained staff from the center; and home based self-practice of yoga daily for three months.
Structured yoga program contains yoga postures, breathing exercise and meditation. It has been developed based upon the recommendation from yoga scientists, from commonly used modules in different yoga centers and literature. It takes 30 minutes to complete. One staff from each center will be trained in yoga packages. The same person will deliver the yoga training to the participants. Participants will be trained on structured yoga for two hours in five days at District Ayurveda Health Centers. After the completion of training, they will be provided a yoga DVD or brochure with instruction and requested to continue it at home once in every morning for next three months. They will be invited for regular follow up to the center on each 14 days. Participants will be asked to record home practices in calendar sheet to monitor progress and encourage accountability. During the follow-up day, outcome measurements as well as qualitative assessment of home-based practice will be conducted and feedback or correction will be provided if needed.
Health education group counseling session will be organized for both intervention and control group. It will be for two hours for single time. The course curriculum and contents will be adopted from the health education materials endorsed by National Health Education Information and Communication Center (NHEICC), Ministry of Health and Population, Nepal. It contains behavioural and life style modification education designed to reduce the
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
The hypertensive persons who will meet the following inclusion criteria will be included in the study
1. Age > 18 years and < 70 years.
2. Blood pressure criteria: SBP of 130 to 159 mm Hg or DBP of 85 to 99 mm Hg
3. With or without antihypertensive medication
4. Attending at District Ayurveda Health Centers
5. Willing to comply with all study-related procedures
|
|
| ExclusionCriteria |
| Details |
1. Pregnant women
2. Known secondary cause of hypertension (renal artery stenosis, pheochromocytoma, coarctation of aorta, hyperaldosteronism).
3. Hypertension (SBP ≥160 mm Hg or DBP ≥100 mm Hg)
4. Established cardiovascular disease
5. Known arrhythmias or cardiac pacemakers
6. Practicing yoga more than one month in the previous 6 months |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in Systolic Blood Pressure level in hypertensive participants |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Diastolic blood pressure
Body Mass Index |
3 months |
|
Target Sample Size
Modification(s)
|
Total Sample Size="140" Sample Size from India="0"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="121" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
08/03/2017 |
| Date of Study Completion (Global) |
20/01/2018 |
|
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The principal objective of the trial is to test whether practicing yoga leads to a clinically relevant reduction in the blood pressure level among people having high blood pressure.
Hypertension is also emerging as the major public health concern in Nepal. The latest NCD risk factors survey reported that nearly quarter (25.7%) of all study population had hypertension. Large proportions of hypertensive participants often have untreated or uncontrolled hypertension. In this context, use of commentary and alternative medicine as an adjuvant therapy can significantly contribute for reducing the burden of hypertension in Nepal. Ayurveda and yoga are the integral parts of health system in Nepal because of their long established traditional practice system, efficacy, availability, safety and affordability. Currently, two central, 14 Zonal and 61 District Ayurveda hospitals and 214 Ayurveda dispensaries are catering preventive, promotive & curative health services throughout Nepal. Department of Ayurveda is now providing a refresher training on yoga to its technical staffs (Ayurved doctors and paramedics) with a view to integrate yoga with Ayurveda health system. However, we still lack the standard scientific evidences that suggest the benefit of yoga on disease management in health centers in Nepal and globally. Even though some studies have reported the beneficial result of yoga in reducing high blood pressure, most of these were either not RCTs or had limitations. Because of lack of strong evidences, yoga has not been widely recognized and practiced for hypertension management in clinical settings in Nepal. Therefore, this study aims to assess the effectiveness of structured yoga program in reducing blood pressure level in hypertensive patients attending District Ayurveda Health Centers in Nepal. We expect the study findings will be useful for the development of hypertension management policy and implement it in Ayurveda health system in Nepal. |