Clinical trial NCT04381520: Heat-sensitive Moxibustion Self-administration in Patients in the Community With Primary Hypertension: Protocol for a Multi-center, Pragmatic, Non-randomized Trial
Official title: Heat-sensitive Moxibustion Self-administration in Patients in the Community With Primary Hypertension: Protocol for a Multi-center, Pragmatic, Non-randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Primary Hypertension
Lead sponsor: Jiangxi University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Nangang community healthcare center (Nanchang city, Jiangxi province, China)
name: Honggutan community healthcare center (Nanchang city, Jiangxi province, China)
name: Shengmi community healthcare center (Nanchang city, Jiangxi province, China)
name: Gaofu town community healthcare center (Fu Zhou city, Jiangxi province, China)
First posted: 2020-05-11
Enrollment: 767
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in systolic blood pressure (mmHg)
timeFrame: Baseline, 6 months, and 12 months
measure: Changes in diastolic blood pressure (mmHg)
timeFrame: Baseline, 6 months, and 12 months
measure: Changes in dose of antihypertensive drugs
timeFrame: Baseline, 6 months, and 12 months
Secondary outcomes:
measure: Total score of quality of life assessed by a validated patient-reported outcome scale
timeFrame: Baseline, 6 months, and 12 months
measure: Physical score of quality of life assessed by a validated patient-reported outcome scale
timeFrame: Baseline, 6 months, and 12 months
measure: Psychological score of quality of life assessed by a validated patient-reported outcome scale
timeFrame: Baseline, 6 months, and 12 months
measure: Family-social score of quality of life assessed by a validated patient-reported outcome scale
timeFrame: Baseline, 6 months, and 12 months
measure: Changes in fasting blood glucose (mg/dl)
timeFrame: Baseline, 6 months, and 12 months
measure: Changes in glycated hemoglobin (%)
timeFrame: Baseline, 6 months, and 12 months
measure: Changes in total cholesterol (mg/dl)
timeFrame: Baseline, 6 months, and 12 months
measure: Changes in triglycerides (mg/dl)
timeFrame: Baseline, 6 months, and 12 months
measure: Changes in low density lipoprotein cholesterol (mg/dl)
timeFrame: Baseline, 6 months, and 12 months
measure: Changes in high density lipoprotein cholesterol (mg/dl)
timeFrame: Baseline, 6 months, and 12 months
measure: Changes in urinary albumin (g/l)
timeFrame: Baseline, 6 months, and 12 months
measure: Changes in serum creatinine (μmol/l)
timeFrame: Baseline, 6 months, and 12 months
Other outcomes:
Locations:
city: Nanchang
country: China
facility: Jiangxi University of Traditional Chinese Medicine
state: Jiangxi
Study officials:
References:
citation: Zhou X, Wu Q, Zhang G, Wang Y, Li S, Wang B, Chen Z, Zhu W, Wang F, Gan C. Heat-sensitive moxibustion self-administration in patients in the community with primary hypertension: A protocol for a multi-center, pragmatic, non-randomized trial. Medicine (Baltimore). 2020 Sep 18;99(38):e22230. doi: 10.1097/MD.0000000000022230.