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| Name | Class |
|---|---|
| Hunan University of Traditional Chinese Medicine | OTHER |
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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.
Investigators plan to recruit 428 hypertensive patients. Eligible patients will be randomized to four different groups.â…°. the affected meridian acupuncture group (AMA, n=107) will be treated with acupoints on affected meridians.â…±.the non-affected meridian acupuncture group (NMA, n=107) will be treated with acupoints on non-affected meridians.â…².invasive sham acupuncture group(ISA, n=107)will be provided with sham acupoints treatment.â…³.waiting-list group(WL, n=107)will not be given any intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acupuncture | Experimental | 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). |
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| Sham acupuncture | Sham Comparator | we use sham acupoints:
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| Waiting list | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| acupuncture | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Visit-to-visit blood pressure variation | Assessed by 24-hour ambulatory blood pressure monitoring | 6 weeks after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Average systolic and average diastolic blood pressure during the daytime and nighttime. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| fan-rong Liang, MD | Chengdu University of Tranditional Chinese Medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chengdu University of Traditional Chinese Medicine | Chengdu | Sichuan | 610075 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33413552 | Derived | 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. | |
| 24216113 | Derived | 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. |
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| ID | Term |
|---|---|
| D000075222 | Essential Hypertension |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| D015671 | Electroacupuncture |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D003131 | Combined Modality Therapy |
| D004599 | Electric Stimulation Therapy |
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| Sham acupuncture | Other | In contrast to acupuncture, sham acupuncture is given at 4 sham points with skin penetration. Electroacupuncture is also applied. |
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The daytime is defined as 8AM-10PM.Nighttime is defined as 10PM -8AM. |
| 0 day, 6weeks, 9weeks, 12weeks after randomization. |
| 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. |
| 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 |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
| D004561 | Transcutaneous Electric Nerve Stimulation |
| D000698 | Analgesia |
| D000760 | Anesthesia and Analgesia |
| D000758 | Anesthesia |