Accepted for/Published in: JMIR Research Protocols
Date Submitted: Jun 16, 2025
Open Peer Review Period: Jun 16, 2025 - Aug 11, 2025
Date Accepted: Nov 17, 2025
Date Submitted to PubMed: Nov 18, 2025
(closed for review but you can still tweet)
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Cardio-cerebral protective effect of moxibustion on phlegm-dampness type hypertension: a study protocol of a randomized clinical trial
ABSTRACT
Background:
Hypertension is associated with a high rate of disability and mortality, leads to a substantial social-economic burden. Moxibustion is an external treatment in traditional Chinese medicine, which was used to treat mild to moderate hypertension in individuals with phlegm-dampness constitution, and had acupoint specificity.
Objective:
a standard large-scale randomized clinical trial to verify its effectiveness is still needed. This study is proposed to examine the clinical effectiveness and potential cardio-protective benefits of moxibustion at home as a treatment for individuals with phlegm-dampness hypertension.
Methods:
This study is a multi-center, randomized, controlled trial. A total of 120 patients with mild to moderate hypertension and phlegm-dampness constitution will be recruited and randomly assigned in a 1:1 ratio to the treatment group (acupoint: Zusanli, ST36) or the control group (acupoint: Xuanzhong, GB39). All patients will receive 12 weeks of treatment and 12-week follow-up period.
Results:
The primary outcome measure is the change in morning systolic blood pressure from baseline to week 12. The secondary outcome measures include blood pressure-related indicators (morning diastolic blood pressure, average systolic blood pressure, average diastolic blood pressure, nighttime systolic blood pressure, nighttime diastolic blood pressure, blood pressure circadian rhythm) and short-term blood pressure variability coefficient, all of which will be measured by 24-hour ambulatory blood pressure monitoring. Additionally, cardiac-related indicators measured by 24-hour Holter monitoring, metabolic disorder-related indicator, liver and kidney function indicators, transformed scores of the TCM phlegm-dampness constitution scale, and the Montreal Cognitive Assessment (MoCA) will also be evaluated.
Conclusions:
This multi-center, randomized, controlled clinical trial will provide evidence on the clinical treatment effectiveness and potential cardio-protective benefits of moxibustion at home as a treatment for individuals with phlegm-dampness type of hypertension. Clinical Trial: This study was registered on Chinese Clinical Trial Registrat ,registry name:Clinical efficacy of moxibustion at Zusanli(St36) in protection cardiovascular and cerebrovascular diseases on phlegm dampness type hypertension;Trial registration number:ChiCTR2400086582);Register date:July 5,2024;https://www.chictr.org.cn/showpro.ChiCTR2400086582
Citation
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Copyright
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