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

NCT ID: NCT04381520

Last Updated: 2021-04-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 767 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-20
• Study Completion Date: 2021-06-30

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.

Conditions

Primary Hypertension

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Heat-sensitive moxibustion plus antihypertensive drugs

Group Type: EXPERIMENTAL

Heat-sensitive moxibustion plus antihypertensive drugs

Intervention Type: OTHER

In this arm, patients will administer heat-sensitive moxibustion by themselves or by the help of their family after professional training. Patients will maintain their original antihypertensive drugs. The periods of treatment and follow-up will be one year.

Antihypertensive drugs

Group Type: ACTIVE_COMPARATOR

Antihypertensive drugs

Intervention Type: DRUG

In this arm, patients will maintain their original antihypertensive drugs. The periods of treatment and follow-up will be one year.

Interventions

Heat-sensitive moxibustion plus antihypertensive drugs

In this arm, patients will administer heat-sensitive moxibustion by themselves or by the help of their family after professional training. Patients will maintain their original antihypertensive drugs. The periods of treatment and follow-up will be one year.

Intervention Type: OTHER

Antihypertensive drugs

In this arm, patients will maintain their original antihypertensive drugs. The periods of treatment and follow-up will be one year.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nangang community healthcare center (Nanchang city, Jiangxi province, China)

UNKNOWN

Sponsor Role: collaborator

Honggutan community healthcare center (Nanchang city, Jiangxi province, China)

UNKNOWN

Sponsor Role: collaborator

Shengmi community healthcare center (Nanchang city, Jiangxi province, China)

UNKNOWN

Sponsor Role: collaborator

Gaofu town community healthcare center (Fu Zhou city, Jiangxi province, China)

UNKNOWN

Sponsor Role: collaborator

Jiangxi University of Traditional Chinese Medicine

OTHER

Sponsor Role: lead

Responsible Party

Xu Zhou

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Jiangxi University of Traditional Chinese Medicine

Nanchang, Jiangxi, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 32957364 (View on PubMed)

Other Identifiers

JXUTCM-Mox-01

Identifier Type: -

Identifier Source: org_study_id