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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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CTRI |
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Last refreshed on:
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24 November 2021 |
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Main ID: |
CTRI/2017/02/007822 |
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Date of registration:
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10-02-2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Impact of a structured yoga program on blood pressure reduction among hypertensive patients in Nepal
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Scientific title:
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Impact of a structured yoga program on blood
pressure reduction among hypertensive patients in Nepal |
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Date of first enrolment:
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08-03-2017 |
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Target sample size:
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140 |
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Recruitment status: |
Completed |
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URL:
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http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=17751 |
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Study type:
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Interventional |
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Study design:
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Randomized, Parallel Group Trial
Method of generating randomization sequence:Stratified block randomization Method of allocation concealment:Centralized Blinding and masking:Open Label
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Phase:
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N/A
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Countries of recruitment
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Nepal
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Contacts
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Name:
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Raja Ram Dhungana
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Address:
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Nepal Family Development Foundation, Kathmandu, Nepal
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Belgaum, KARNATAKA
Other |
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Telephone:
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9841077291 |
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Email:
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raja.dhungana@gmail.com |
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Affiliation:
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Nepal Family Development Foundation |
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Name:
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Raja Ram Dhungana
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Address:
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Nepal Family Development Foundation, Kathmandu, Nepal
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Belgaum, KARNATAKA
Other |
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Telephone:
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9841077291 |
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Email:
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raja.dhungana@gmail.com |
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Affiliation:
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Nepal Family Development Foundation |
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Key inclusion & exclusion criteria
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Inclusion criteria: 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
Exclusion criteria: 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
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Health Condition 1: null- The hypertensive persons who have blood pressure: SBP of 130 to 159 mm Hg or DBP of 85 to 99 mm Hg
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Intervention(s)
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Intervention1: 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
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Primary Outcome(s)
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Reduction in Systolic Blood Pressure level in hypertensive participantsTimepoint: 3 months
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Secondary Outcome(s)
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Diastolic blood pressure
Body Mass IndexTimepoint: 3 months
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Source(s) of Monetary Support
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District Ayurveda Health Centers
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Ethics review
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Status: Approved
Approval date: 05/01/2017
Contact:
Nepal Health Research Council
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Status: Approved
Approval date: 25/04/2018
Contact:
Nepal Health research Council
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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