Home » Trials » SLCTR/2017/029
A randomised controlled trial to assess the effectiveness of acupuncture in reducing high blood pressure among patients with essential hypertension in the Chitwan district of Nepal
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SLCTR Registration Number
SLCTR/2017/029
Date of Registration
The date of last modification
Mar 03, 2019
Scientific Title of Trial
A randomised controlled trial to assess the effectiveness of acupuncture in reducing high blood pressure among patients with essential hypertension in the Chitwan district of Nepal
Public Title of Trial
Acupuncture therapy in reducing high blood pressure
Disease or Health Condition(s) Studied
Hypertension
Scientific Acronym
None
Public Acronym
ACE Trial
Brief title
Acupuncture in Hypertension
Universal Trial Number
U1111-1201-0330
Any other number(s) assigned to the trial and issuing authority
118/2017 (ERB: Nepal Health Research Council)
What is the research question being addressed?
Is acupuncture effective in reducing blood pressure in patients with essential hypertension?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Treatment
Study Phase
Not Applicable
Intervention(s) planned
The trial will be conducted in selected health facilities in Chitwan, Nepal
Once the participants meet the inclusion and exclusion criteria at the screening visit, there will be one week run in period, and the participants will be randomised either to the intervention group or the control group using simple randomization.
The intervention group will receive acupuncture intervention three times a week for six weeks and follow up period of once a week for six weeks. Systolic and diastolic blood pressure will be measured at each visit.
The control group will have no intervention but the systolic and diastolic Blood pressure will be measured and recorded three times a week for 6 weeks and thereafter once a week for 6 weeks.
Both groups will receive their regular hypertensive medication or the therapy that the participants are taking for the treatment of hypertension as prescribed by their physician.
The intervention is given on the top of the standard care. No changes will be made on the standard care during the course of the study
Inclusion criteria
Men and women aged 30 - 70 years.
Participants who meet the diagnostic criteria of hypertension according to the International society of Hypertension Guidelines, 2013
Exclusion criteria
Participants diagnosed with disorders in heart, kidney, thyroid gland, diabetes, neurological disease, skin or bleeding disorders and currently on any drugs or medications for any other chronic disease.
Primary outcome(s)
|
1.
Change in systolic and diastolic blood pressure. Outcome will be measured using standardized stethoscopes and sphygmomanometers, by following standard measurement techniques. |
[ 3 times a week for 6 weeks done at each visit during the intervention phase and once a week at follow up phase for 6 weeks. Blood pressure will be measured just before the treatment, during the treatment and after the treatment. ] |
Secondary outcome(s)
|
1.
Any adverse events due to the intervention defined as, pain, swelling around the intervention area. The grading will be done as : Very Mild, Mild, Moderate, Severe to Very Severe |
[ 3 times a week for 6 weeks done at each visit during the intervention phase and once a week at follow up phase for 6 weeks. ] |
Target number/sample size
300 (150 in each arm)
Countries of recruitment
Nepal
Anticipated start date
2017-10-09
Anticipated end date
2018-02-20
Date of first enrollment
Date of study completion
Recruitment status
Withdrawn
Funding source
Ministry of Health, Government of Nepal and Barefoot clinic UK
Regulatory approvals
Not applicable
Status
Approved
Date of Approval
2017-06-14
Approval number
118/2017
Details of Ethics Review Committee
| Name: | Ethical Review Board of Nepal Health Research Council |
| Institutional Address: | PO Box 7626, Ramshah Path, Kathmandu, Nepal |
| Telephone: | +977-14254220 |
| Email: | nhrc@nhrc.gov.np |
Contact person for Scientific Queries/Principal Investigator
Prof. Dr. Anjani Kumar Jha
Executive Chairman
Nepal Health Research Council
Ramshah Path, Kathmandu, Nepal
977-014227460
dranjanikj@gmail.com
Contact Person for Public Queries
Shristi Karki
Research officer
Ramshah path, Kathmandu, Nepal
977-014227460
9808426339
shristi.karki1@gmail.com
Primary study sponsor/organization
Ministry of Health, Government of Nepal
Ramshahpath, Kathmandu, Nepal
Secondary study sponsor (If any)
Barefoot clinic UK
48 Stirtingale Road, Kingsway, Bath AVON
UK
01225 4681695
Lea.leilani@gmail.com
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Not Available
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
