Effect of Acupuncture on Patients With Mild Hypertension

Phase 3

Completed

• Conditions: Essential Hypertension
• Interventions: Other: acupuncture; Other: Sham acupuncture

• Registration Number: NCT01701726
• Lead Sponsor: Chengdu University of Traditional Chinese Medicine

Brief Summary

This is a large scale, open-label, multicenter, randomized controlled clinical trial with four parallel arms. This trial aims to evaluate the effectiveness of affected meridian acupuncture for patients with mild hypertension,with respect to decreasing their blood pressure, safety of acupuncture ,and improving their quality of life as well.

Detailed Description

Investigators plan to recruit 428 hypertensive patients. Eligible patients will be randomized to four different groups.ⅰ. the affected meridian acupuncture group (AMA, n=107) will be treated with acupoints on affected meridians.ⅱ.the non-affected meridian acupuncture group (NMA, n=107) will be treated with acupoints on non-affected meridians.ⅲ.invasive sham acupuncture group(ISA, n=107)will be provided with sham acupoints treatment.ⅳ.waiting-list group(WL, n=107)will not be given any intervention.

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-09-26
• Study First Submitted QC: 2012-10-04
• Study First Posted: 2012-10-05
• Primary Completion: 2016-02
• Study Completion: 2016-04
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-19
• Last Update Posted: 2016-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

Not provided

Exclusion Criteria

1. Patients who have been diagnosed as secondary hypertension or malignant hypertension(e.g. Cushing's syndrome, coarctation of the aorta，phaeochromocytoma, renal parenchymal disease，primary aldosteronism， renovascular hypertension, obstructive sleep apnoea，drug induced hypertension et al )
2. Patients who accompany with other severe medical conditions (e.g. endocrine disorders, cardiovascular disease. Digestive disease. hepatic dysfunction，cerebral vascular disease. renal disease. haematologic disease et al). Who may be not safe to join our study.
3. Patients with a chronic disease which might not suitable for our study. e.g: epilepsy ,severe depression or anxiety (SAS≥70,SDS≥70) ,psychosis, allergic constitution, accompany with any infection.
4. Pregnant women or women in lactation or women of child bearing potential plan to conceive in the recent six months.
5. Patients who currently participate in another clinical trial.
6. Patients who Had been treated with acupuncture during the previous three months
7. If one of the tips mentioned above is matched will be excluded.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acupuncture	acupuncture	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).
Sham acupuncture	Sham acupuncture	we use sham acupoints: 1. The edge of the tibia (1-2cm lateral and horizontal to the zusanli (ST36)) 2. Half way between the tip of the elbow and the axilla 3. On the ulnar side of the arm, half way between the epicondylus medialis of the humerus and the ulnar side of the wrist. 4. 2cm superior to fu tu(LI18)

Primary Outcome Measures

Name	Time	Method
Average systolic and average diastolic blood pressure by 24-hour ambulatory blood pressure monitoring	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	6 weeks after randomization	Assessed by 24-hour ambulatory blood pressure monitoring

Secondary Outcome Measures

Name	Time	Method
Average systolic and average diastolic blood pressure during the daytime and nighttime.	0 day, 6weeks, 9weeks, 12weeks after randomization.	The daytime is defined as 8AM-10PM.Nighttime is defined as 10PM -8AM.
Adverse events	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.
changes in patients health-related quality of life	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.

Trial Locations

Locations (1)

Chengdu University of Traditional Chinese Medicine; 🇨🇳 Chengdu, Sichuan, China