Cardio-Cerebral Protective Effect of Moxibustion on Phlegm-Dampness Type Hypertension: Protocol for a Randomized Controlled Trial (Preprint)

BACKGROUND Hypertension is associated with a high rate of disability and mortality and leads to a substantial socioeconomic burden. Moxibustion is an external treatment in traditional Chinese medicine that has been used to treat mild to moderate hypertension in individuals with phlegm-dampness constitution and has demonstrated acupoint specificity. However, a standard large-scale randomized controlled trial is still needed to verify its effectiveness. This study is proposed to examine the clinical effectiveness and potential cardioprotective benefits of moxibustion performed at home as a treatment for individuals with phlegm-dampness hypertension. OBJECTIVE The objective of this trial is to evaluate the cardio-cerebral protective clinical efficacy of moxibustion for phlegm-dampness type hypertension and to explore its acupoint specific effects. METHODS This study is a multicenter, 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 a 12-week follow-up period. 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, and 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 indicators, liver and kidney function indicators, transformed scores of the traditional Chinese medicine phlegm-dampness constitution scale, and the Montreal Cognitive Assessment will also be evaluated. RESULTS This study was registered on July 5, 2024, with the Chinese Clinical Trial Registry. Data collection began in June 2023 and ended in February 2025. Currently, data from this trial are in the collection phase, and no data analysis has been performed. As of January 2025, we have collected data from 118 patients. The results of this trial are expected to be submitted for publication in May 2026. CONCLUSIONS This multicenter, randomized, controlled clinical trial will provide evidence on the clinical effectiveness and potential cardioprotective benefits of moxibustion performed at home as a treatment for individuals with phlegm-dampness type of hypertension. CLINICALTRIAL Chinese Clinical Trial Registry ChiCTR2400086582; https://www.chictr.org.cn/showproj.html?proj=211688 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/79158