Effect of Acupuncture on Patients With Mild Hypertension (EAPMH)
|ClinicalTrials.gov Identifier: NCT01701726|
Recruitment Status : Completed
First Posted : October 5, 2012
Last Update Posted : June 21, 2016
|Condition or disease||Intervention/treatment||Phase|
|Essential Hypertension||Other: acupuncture Other: Sham acupuncture||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||400 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Acupuncture for Patients With Mild Hypertension: Study Protocol of an Open-label Multicenter Randomized Controlled Trial|
|Study Start Date :||July 2012|
|Primary Completion Date :||February 2016|
|Study Completion Date :||April 2016|
Two types of acupuncture are given, one is acupuncture at affected meridian points, the other is at non-affected. For the first type, We select the acupoints from the affected meridians.Patients in this group are divided into two subgroups according meridian syndrome differentiation(jue-yin style,yang-ming style).Patients pertaining to Jue-yin-style are treated with taichong (LR3), renying(ST9), taixi(KI3), neiguan(PC6) .Patients pertaining to Yang-ming-style: taichong(LR3), renying(ST9), zusanli(ST36), quchi(LI11). For the second,We select the acupoints from the non-affected meridians.Patients assigned into the non-affected meridian acupuncture group will be treated with Fengchi (GB20), waiguan(SJ5), yinlingquan(SP9), xuehai (SP10).
In each session, acupuncture are applied bilaterally. Except the acupoints around the neck(ST9.GB20.non-acupoints 4) ,6 auxiliary needles will be punctured at 2mm lateral to each acupoints or non-acupoints.as to auxiliary needle we will not do any manipulation. We use transcutaneous electric acupoints stimulation to stimulate the acupoints and non-acupoints.
Other Name: electroacupuncture
Sham Comparator: Sham acupuncture
we use sham acupoints:
Other: Sham acupuncture
In contrast to acupuncture, sham acupuncture is given at 4 sham points with skin penetration. Electroacupuncture is also applied.
No Intervention: Waiting list
Participants who will be randomized into the waiting-list group will not receive any acupuncture treatment throughout 13-week observation period. At the end of trial, if the participant would like to be treated with acupuncture, it will be provided three times weekly for 6 weeks.
- Average systolic and average diastolic blood pressure by 24-hour ambulatory blood pressure monitoring [ Time Frame: 6weeks after randomization. ]The primary outcome is the average systolic and average diastolic blood pressure measured at 6 weeks after randomization by 24-hour ambulatory blood pressure monitoring.
- Visit-to-visit blood pressure variation [ Time Frame: 6 weeks after randomization ]Assessed by 24-hour ambulatory blood pressure monitoring
- Average systolic and average diastolic blood pressure during the daytime and nighttime. [ Time Frame: 0 day, 6weeks, 9weeks, 12weeks after randomization. ]The daytime is from 8AM to 10PM,nighttime is 10PM -8AM.
- Average systolic and average diastolic blood pressure during the daytime and nighttime. [ Time Frame: 0 day, 6weeks, 9weeks, 12weeks after randomization. ]The daytime is defined as 8AM-10PM.Nighttime is defined as 10PM -8AM.
- changes in patients health-related quality of life [ Time Frame: 0 day and 6 weeks after randomization. ]SF-36 (Medical Outcomes Study 36-Item Short Form)questionnaire Chinese version. The scale contains eight dimensions (physical function, role physical, bodily pain, general health, vitality, social function, role emotional, mental health) and two summary components (physical and mental ),scale 0-100.lower scores indicate poorer quality of life.
- Adverse events [ Time Frame: 0 day, 6weeks, 9weeks, 12weeks after randomization ]Adverse events are defined as any unexpected or discomfort signs, symptoms or diseases, regardless of the intervention. If any adverse events happen during the entire observation period, all the details should be documented in the case report form. These adverse events include bleeding, hematoma, fainting, serious pain, and local infection.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01701726
|Chengdu University of Traditional Chinese Medicine|
|Chengdu, Sichuan, China, 610075|
|Study Chair:||fan-rong Liang, MD||Chengdu University of Tranditional Chinese Medicine|