Clinical trial NCT01701726: Effect of Acupuncture on Patients With Mild Hypertension
Official title: Acupuncture for Patients With Mild Hypertension: Study Protocol of an Open-label Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Essential Hypertension
Keywords: Essential Hypertension
Acupuncture
Specificity
Acupoints effect
randomized controlled trials
Lead sponsor: Chengdu University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Hunan University of Traditional Chinese Medicine
First posted: 2012-10-05
Enrollment: 400
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Average systolic and average diastolic blood pressure by 24-hour ambulatory blood pressure monitoring
timeFrame: 6weeks after randomization.
measure: Visit-to-visit blood pressure variation
timeFrame: 6 weeks after randomization
Secondary outcomes:
measure: Average systolic and average diastolic blood pressure during the daytime and nighttime.
timeFrame: 0 day, 6weeks, 9weeks, 12weeks after randomization.
measure: Average systolic and average diastolic blood pressure during the daytime and nighttime.
timeFrame: 0 day, 6weeks, 9weeks, 12weeks after randomization.
measure: changes in patients health-related quality of life
timeFrame: 0 day and 6 weeks after randomization.
measure: Adverse events
timeFrame: 0 day, 6weeks, 9weeks, 12weeks after randomization
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Chengdu University of Traditional Chinese Medicine
state: Sichuan
Study officials:
affiliation: Chengdu University of Tranditional Chinese Medicine
name: fan-rong Liang, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.