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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  
Name  Address 
none  none 
 
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  
Status 
Not Applicable 
 
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.

 
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