Clinical trial NCT04788563: A Randomized Patient Preference Trial on Heat-sensitive Moxibustion for Primary Hypertension in Community
Official title: Heat-sensitive Moxibustion Self-administration for Primary Hypertension in Community: A Multicenter, Pragmatic, Randomized Controlled Trial With Patient Preference Arms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Hypertension
Lead sponsor: Jiangxi University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2021-03-09
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial with patient preference arms
Primary purpose: TREATMENT

Brief summary: Heat-sensitive moxibustion, an important mean of external therapy of traditional Chinese medicine, has unique advantages in treating various chronic diseases than common moxibustion. This study aims to evaluate the efficacy, safety, and cost-effectiveness of heat-sensitive moxibustion for primary hypertension under community self-management setting using a multicenter, pragmatic, randomized controlled trial design with patient-preference arms.

Detailed description: Primary hypertension is a common chronic disease that threatens the life and health of human beings. The conventional western drug therapy often has side effects and many patients are unable to achieve ideal blood pressure control with drugs alone. Therefore, the treatment of primary hypertension still requires active exploration of complementary and alternative therapies with clear clinical efficacy.

Heat-sensitive moxibustion is an innovative moxibustion therapy. By stimulating the patient's special moxibustion sensation, heat-sensitive moxibustion can achieve better results than traditional moxibustion for many diseases, including primary hypertension. Heat-sensitive moxibustion is an easy, inexpensive and safe treatment method. The practitioner does not need to be professionally qualified to perform moxibustion, making it a suitable technique for patients to self-medicate on a daily basis. Traditional moxibustion has been shown to lower blood pressure in patients with primary hypertension. Theoretically, heat-sensitive moxibustion could achieve better blood pressure lowering effects, but its effects in lowering blood pressure in the setting of self-management in community patients is unclear. To verify the efficacy and safety of heat-sensitive moxibustion community self-management for hypertension, we plan to perform a randomized controlled trial. In this trial, we designed the trial grouping scheme as a randomized controlled trial with patient preference arms in order to improve patient adherence and reduce the impact of patient preference effects.

Eligibility criteria: Inclusion Criteria:

1. Diagnosed with essential hypertension, i.e., systolic blood pressure ≥ 140mmHg and/or diastolic blood pressure ≥ 90 mmHg, with a course more than 6 months.
2. Ages: 18-80 years;
3. The original antihypertensive drugs are calcium channel blockers and/or angiotensin II receptor blockers.
4. Did not receive acupoint stimulation therapies for hypertension in the last month.
5. Patients in the heat-sensitive moxibustion groups need to develop at least one type of moxibustion sensation around the following acupoints: Yongquan, Baihui, Shenque, Quchi, Zusanli, Hegu, Taichong and Dazhui.
6. Consent to sign an informed consent form

Exclusion Criteria:

1. Systolic blood pressure ≥ 180mmHg and/or diastolic blood pressure ≥ 110mmHg after taking antihypertensive drugs;
2. Secondary hypertension.
3. Pregnancy and lactation;
4. Allergic to moxibustion devices, moxa smoke or Artemisia argyi.
5. Complicated with severe diseases that are not recommended for heat-sensitive moxibustion, such as acute cerebral hemorrhage, hypertensive crisis, sensory disturbances, serious mental diseases, etc.

Primary outcomes:
measure: Systolic blood pressure
timeFrame: Baseline and months 1, 2, 3, 4, 5, and 6
Secondary outcomes:
measure: Diastolic blood pressure
timeFrame: Baseline and months 1, 2, 3, 4, 5, and 6
measure: Response to treatment
timeFrame: Baseline and months 1, 2, 3, 4, 5, and 6
measure: Dose of antihypertensive drugs
timeFrame: Measure at baseline screening, monthly for 6 months
measure: Score of EQ-5D-5L
timeFrame: Baseline and months 3 and 6
measure: Symptom score
timeFrame: Baseline and months 3 and 6
measure: Cost-effectiveness ratio
timeFrame: Baseline and months 1, 2, 3, 4, 5, and 6
measure: Patients' compliance to heat-sensitive moxibustion
timeFrame: Baseline and months 1, 2, 3, 4, 5, and 6
measure: Incidence of cardiovascular events
timeFrame: Baseline and months 1, 2, 3, 4, 5, and 6
measure: Any adverse events
timeFrame: Baseline and months 1, 2, 3, 4, 5, and 6
measure: Heat-sensitive moxibustion-related adverse events
timeFrame: Baseline and months 1, 2, 3, 4, 5, and 6
Other outcomes:
Locations:
city: Nanchang
country: China
facility: Erliuling
state: Jiangxi
city: Nanchang
country: China
facility: Hongmiao
state: Jiangxi
city: Nanchang
country: China
facility: Jinghexinggong community
state: Jiangxi
city: Nanchang
country: China
facility: Jinsheng community
state: Jiangxi
city: Nanchang
country: China
facility: Nangang community
state: Jiangxi
city: Nanchang
country: China
facility: Shajing
state: Jiangxi
city: Nanchang
country: China
facility: Wuliangdian community
state: Jiangxi
Study officials:
affiliation: Jiangxi University of Traditional Chinese Medicine
name: Xu Zhou, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhou X, Li S, Li L, Deng G, Dai L, Chai L, Wu Q, Yao Z, Deng M, Zhu W, Fu Y, Sun X. Community-based heat-sensitive moxibustion for primary hypertension: study protocol for a randomized controlled trial with patient-preference arms. Trials. 2022 Feb 16;23(1):154. doi: 10.1186/s13063-022-06092-4.