Effect of Acupuncture on Patients With Mild Hypertension

Essential Hypertension Clinical Trial

— EAPMH  

Official title:

Acupuncture for Patients With Mild Hypertension: Study Protocol of an Open-label Multicenter Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01701726
• Other study ID #: 2012CB518501-1
• Status: Completed
• Phase: Phase 3
• First received: September 26, 2012
• Last updated: June 19, 2016
• Start date: July 2012
• Est. completion date: April 2016

Study information

• Verified date: June 2016
• Source: Chengdu University of Traditional Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Science and Technology
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: April 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Essential Hypertension
• Hypertension

Intervention

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

Locations

Country	Name	City	State
China	Chengdu University of Traditional Chinese Medicine	Chengdu	Sichuan

Sponsors (2)

Lead Sponsor	Collaborator
Chengdu University of Traditional Chinese Medicine	Hunan University of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average systolic and average diastolic blood pressure by 24-hour ambulatory blood pressure monitoring	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.	6weeks after randomization.	No
Primary	Visit-to-visit blood pressure variation	Assessed by 24-hour ambulatory blood pressure monitoring	6 weeks after randomization	No
Secondary	Average systolic and average diastolic blood pressure during the daytime and nighttime.	The daytime is from 8AM to 10PM,nighttime is 10PM -8AM.	0 day, 6weeks, 9weeks, 12weeks after randomization.	No
Secondary	Average systolic and average diastolic blood pressure during the daytime and nighttime.	The daytime is defined as 8AM-10PM.Nighttime is defined as 10PM -8AM.	0 day, 6weeks, 9weeks, 12weeks after randomization.	No
Secondary	changes in patients health-related quality of life	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.	0 day and 6 weeks after randomization.	No
Secondary	Adverse events	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.	0 day, 6weeks, 9weeks, 12weeks after randomization	Yes