SLCTR Registration Number
Date of Registration
The date of last modification
Sep 06, 2017
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 of Health Condition(s) Studied
Acupuncture in Hypertension
Universal Trial Number
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
Randomized controlled trial
Masking not used
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
Men and women aged 30 - 70 years.
Participants who meet the diagnostic criteria of hypertension according to the International society of Hypertension Guidelines, 2013
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.
Change in systolic and diastolic blood pressure. Outcome will be measured using standardized stethoscopes and sphygmomanometers, by following standard measurement techniques.
Primary outcome(s) - Time of assessment(s)
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.
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
Secondary outcome(s) - Time of assessment(s)
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
Anticipated start date
Anticipated end date
State of ethics review approval
Approved from Ethical Review Board of Nepal Health Research Council
Ministry of Health, Government of Nepal and Barefoot clinic UK
Contact person for Scientific Queries/Principal Investigator
Prof. Dr. Anjani Kumar Jha
Nepal Health Research Council Ramshah Path, Kathmandu, Nepal
Contact Person for Public Queries
Ramshah path, Kathmandu, Nepal
Primary study sponsor/organization
Secondary study sponsor (If any)
Barefoot clinic UK
48 Stirtingale Road, Kingsway, Bath AVON UK