Heat-sensitive Moxibustion Self-administration in Patients in the Community With Primary Hypertension: Protocol for a Multi-center, Pragmatic, Non-randomized Trial

Jiangxi University of Traditional Chinese Medicine

Status: Unknown

Conditions: Primary Hypertension

Treatments: Drug: Antihypertensive drugs; Other: Heat-sensitive moxibustion plus antihypertensive drugs

Study type: Interventional

Funder types: Other

Identifiers

NCT04381520

JXUTCM-Mox-01

Details and patient eligibility

About

Heat-sensitive moxibustion is considered to be effective for primary hypertension in hospital setting. This study aims to investigate whether heat-sensitive moxibustion self-administration is effective for lowering blood pressure and improving quality of life for patients with primary hypertension in community setting using a multicenter, prospective, non-randomized study design

Full description

Primary hypertension is a global health issue with high incidence; it affected approximately 1.13 billion people worldwide and directly or indirectly causing an 10.4 million of death yearly. The routine drugs for primary hypertension are limited by adverse effects and expensive costs. Therefore, complementary and alternative medicine with good efficacy and safety and low expenditure is still needed for primary hypertension, especially in poverty-stricken areas.

Heat-sensitive moxibustion is an innovative therapy developed on the basis of traditional moxibustion. Compared with traditional moxibustion, heat-sensitive moxibustion advocates finding heat-sensitive acupoints where patients have special reactions to moxibustion heat, including diathermy, heat transfer, soreness, etc. The application of moxibustion on heat-sensitive acupoints (i.e., heat-sensitive moxibustion) has been shown to be more effective to traditional moxibustion for many diseases, including primary hypertension. Moreover, compared with acupuncture, heat-sensitive moxibustion has a main advantage that moxibustion does not require professional qualifications and patients can self-administer moxibustion after professional training. However, the current evidence is generated only from hospital settings. Therefore, this study is specifically designed to investigate whether heat-sensitive moxibustion self-administration is an effective intervention for lowering blood pressure and improving quality of life for patients with primary hypertension in community setting.

Enrollment: 767 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Meet the diagnostic criteria of primary hypertension
2. 18 to 70 years old
3. Sign the informed consent

Exclusion criteria

1. Secondary hypertension caused by kidney disease, macrovascular disease, pregnancy, endocrine disease, brain disease, drug-induced factors, etc.
2. Allergic to moxibustion equipment, moxa smoke or moxa
3. Pregnancy or lactation
4. A history of serious cardiovascular and cerebrovascular events such as cerebrovascular accidents and myocardial infarction
5. Complicated by liver and kidney dysfunction indicated by total bilirubin, alanine aminotransferase, aspartate aminotransferase, or blood creatinine are more than 2 times upper limit of normal value
6. Complicated by malignant tumors
7. Complicated by major mental disorders

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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767 participants in 2 patient groups

Heat-sensitive moxibustion plus antihypertensive drugs

Experimental group

Treatment:

Other: Heat-sensitive moxibustion plus antihypertensive drugs

Antihypertensive drugs

Active Comparator group

Treatment:

Drug: Antihypertensive drugs