Effect of Acupuncture on Patients With Mild Hypertension

NCT ID: NCT01701726

Last Updated: 2016-06-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2016-04-30

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.

Conditions

Essential Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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).

Group Type: EXPERIMENTAL

acupuncture

Intervention Type: OTHER

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.

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)

Group Type: SHAM_COMPARATOR

Sham acupuncture

Intervention Type: OTHER

In contrast to acupuncture, sham acupuncture is given at 4 sham points with skin penetration. Electroacupuncture is also applied.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

acupuncture

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.

Intervention Type: OTHER

Sham acupuncture

In contrast to acupuncture, sham acupuncture is given at 4 sham points with skin penetration. Electroacupuncture is also applied.

Intervention Type: OTHER

Other Intervention Names

electroacupuncture

Eligibility Criteria

Inclusion Criteria

1. Patients whose age between 40 and 75 years old, male and female;

2. Patients who meet the diagnostic criteria of mild hypertension according to JNC-7 and China's prevention and cure guide of hypertension. mild hypertension (WHO/ISH criteria stage I) Systolic blood pressure 159≥(SBP) ≥140 and/or diastolic blood pressure 99≥(DBP) ≥90 .

3. Patients who are initially diagnosed as mild hypertension or have been diagnosed as mild hypertension before but have not taken any antihypertensive drugs.

4. Patients who are diagnosed as yue-yin style (yin-deficiency accompany with hyperactivity of yang) or yang-ming style (obstruction of phlegm and dampness) according to meridian syndrome differentiation

5. Patients who have a good understanding of our study. and willing to comply with our study protocol.

6. Informed consent form must be signed by patient or lineal relative.

7. All the tips are matched will be included.

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hunan University of Traditional Chinese Medicine

OTHER

Sponsor Role: collaborator

Chengdu University of Traditional Chinese Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

fan-rong Liang, MD

Role: STUDY_CHAIR

Chengdu University of Tranditional Chinese Medicine

Locations

Chengdu University of Traditional Chinese Medicine

Chengdu, Sichuan, China

Countries

China

References

Wang JM, Yang MX, Wu QF, Chen J, Deng SF, Chen L, Wei DN, Liang FR. Improvement of intestinal flora: accompany with the antihypertensive effect of electroacupuncture on stage 1 hypertension. Chin Med. 2021 Jan 7;16(1):7. doi: 10.1186/s13020-020-00417-8.

Reference Type: DERIVED

PMID: 33413552 (View on PubMed)

Li J, Zheng H, Zhao L, Li Y, Zhang Y, Chang XR, Wang RH, Shi J, Cui J, Huang YL, Li X, Chen J, Li DH, Liang FR. Acupuncture for patients with mild hypertension: study protocol of an open-label multicenter randomized controlled trial. Trials. 2013 Nov 11;14:380. doi: 10.1186/1745-6215-14-380.

Reference Type: DERIVED

PMID: 24216113 (View on PubMed)

Other Identifiers

2012CB518501-1

Identifier Type: -

Identifier Source: org_study_id