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

Primary Hypertension Clinical 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04381520
• Other study ID #: JXUTCM-Mox-01
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 20, 2020
• Est. completion date: June 30, 2021

Study information

• Verified date: April 2021
• Source: Jiangxi University of Traditional Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 767
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Essential Hypertension
• Hypertension
• Primary Hypertension

Intervention

Other:
• 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.

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

Locations

Country	Name	City	State
China	Jiangxi University of Traditional Chinese Medicine	Nanchang	Jiangxi

Sponsors (5)

Lead Sponsor	Collaborator
Jiangxi University of Traditional Chinese Medicine	Gaofu town community healthcare center (Fu Zhou city, Jiangxi province, China), Honggutan community healthcare center (Nanchang city, Jiangxi province, China), Nangang community healthcare center (Nanchang city, Jiangxi province, China), Shengmi community healthcare center (Nanchang city, Jiangxi province, China)

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in systolic blood pressure (mmHg)		Baseline, 6 months, and 12 months
Primary	Changes in diastolic blood pressure (mmHg)		Baseline, 6 months, and 12 months
Primary	Changes in dose of antihypertensive drugs	Measured by percentage changes	Baseline, 6 months, and 12 months
Secondary	Total score of quality of life assessed by a validated patient-reported outcome scale	Including 27 items and assessing impacts of hypertension on on the three dimensions, physical (18 items), psychological (4 items) and family-social (5 items). Each item is classified as five grades (0-4 points). The total score ranges from 0 to 108 points. A higher score indicates a worse quality of life.	Baseline, 6 months, and 12 months
Secondary	Physical score of quality of life assessed by a validated patient-reported outcome scale	Including 18 items. Each item is classified as five grades (0-4 points). The total score ranges from 0 to 72 points. A higher score indicates a worse quality of life.	Baseline, 6 months, and 12 months
Secondary	Psychological score of quality of life assessed by a validated patient-reported outcome scale	Including 4 items. Each item is classified as five grades (0-4 points). The total score ranges from 0 to 16 points. A higher score indicates a worse quality of life.	Baseline, 6 months, and 12 months
Secondary	Family-social score of quality of life assessed by a validated patient-reported outcome scale	Including 5 items. Each item is classified as five grades (0-4 points). The total score ranges from 0 to 20 points. A higher score indicates a worse quality of life.	Baseline, 6 months, and 12 months
Secondary	Changes in fasting blood glucose (mg/dl)		Baseline, 6 months, and 12 months
Secondary	Changes in glycated hemoglobin (%)		Baseline, 6 months, and 12 months
Secondary	Changes in total cholesterol (mg/dl)		Baseline, 6 months, and 12 months
Secondary	Changes in triglycerides (mg/dl)		Baseline, 6 months, and 12 months
Secondary	Changes in low density lipoprotein cholesterol (mg/dl)		Baseline, 6 months, and 12 months
Secondary	Changes in high density lipoprotein cholesterol (mg/dl)		Baseline, 6 months, and 12 months
Secondary	Changes in urinary albumin (g/l)		Baseline, 6 months, and 12 months
Secondary	Changes in serum creatinine (µmol/l)		Baseline, 6 months, and 12 months