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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

06 Sep 2017

The date of last modification

Jan 28, 2019



Application Summary


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)


Trial Details


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

  1. Men and women aged 30 - 70 years.

  2. 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



State of Ethics Review Approval


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 & Sponsor Information


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

Trial Completion details


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