Heat-sensitive Moxibustion Self-administration in Patients in the Community With Primary Hypertension: Protocol for a Multi-center, Pragmatic, Non-randomized Trial
Primary Purpose
Primary Hypertension
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Heat-sensitive moxibustion plus antihypertensive drugs
Antihypertensive drugs
Sponsored by
About this trial
This is an interventional treatment trial for Primary Hypertension
Eligibility Criteria
Inclusion Criteria:
- Meet the diagnostic criteria of primary hypertension
- 18 to 70 years old
- Sign the informed consent
Exclusion Criteria:
- Secondary hypertension caused by kidney disease, macrovascular disease, pregnancy, endocrine disease, brain disease, drug-induced factors, etc.
- Allergic to moxibustion equipment, moxa smoke or moxa
- Pregnancy or lactation
- A history of serious cardiovascular and cerebrovascular events such as cerebrovascular accidents and myocardial infarction
- 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
- Complicated by malignant tumors
- Complicated by major mental disorders
Sites / Locations
- Jiangxi University of Traditional Chinese Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Heat-sensitive moxibustion plus antihypertensive drugs
Antihypertensive drugs
Arm Description
Outcomes
Primary Outcome Measures
Changes in systolic blood pressure (mmHg)
Changes in diastolic blood pressure (mmHg)
Changes in dose of antihypertensive drugs
Measured by percentage changes
Secondary Outcome Measures
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.
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.
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.
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.
Changes in fasting blood glucose (mg/dl)
Changes in glycated hemoglobin (%)
Changes in total cholesterol (mg/dl)
Changes in triglycerides (mg/dl)
Changes in low density lipoprotein cholesterol (mg/dl)
Changes in high density lipoprotein cholesterol (mg/dl)
Changes in urinary albumin (g/l)
Changes in serum creatinine (μmol/l)
Full Information
NCT ID
NCT04381520
First Posted
May 6, 2020
Last Updated
April 1, 2021
Sponsor
Jiangxi University of Traditional Chinese Medicine
Collaborators
Nangang community healthcare center (Nanchang city, Jiangxi province, China), Honggutan community healthcare center (Nanchang city, Jiangxi province, China), Shengmi community healthcare center (Nanchang city, Jiangxi province, China), Gaofu town community healthcare center (Fu Zhou city, Jiangxi province, China)
1. Study Identification
Unique Protocol Identification Number
NCT04381520
Brief Title
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
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 20, 2020 (Actual)
Primary Completion Date
June 30, 2021 (Anticipated)
Study Completion Date
June 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jiangxi University of Traditional Chinese Medicine
Collaborators
Nangang community healthcare center (Nanchang city, Jiangxi province, China), Honggutan community healthcare center (Nanchang city, Jiangxi province, China), Shengmi community healthcare center (Nanchang city, Jiangxi province, China), Gaofu town community healthcare center (Fu Zhou city, Jiangxi province, China)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
767 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Heat-sensitive moxibustion plus antihypertensive drugs
Arm Type
Experimental
Arm Title
Antihypertensive drugs
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Heat-sensitive moxibustion plus antihypertensive drugs
Intervention Description
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
Drug
Intervention Name(s)
Antihypertensive drugs
Intervention Description
In this arm, patients will maintain their original antihypertensive drugs. The periods of treatment and follow-up will be one year.
Primary Outcome Measure Information:
Title
Changes in systolic blood pressure (mmHg)
Time Frame
Baseline, 6 months, and 12 months
Title
Changes in diastolic blood pressure (mmHg)
Time Frame
Baseline, 6 months, and 12 months
Title
Changes in dose of antihypertensive drugs
Description
Measured by percentage changes
Time Frame
Baseline, 6 months, and 12 months
Secondary Outcome Measure Information:
Title
Total score of quality of life assessed by a validated patient-reported outcome scale
Description
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.
Time Frame
Baseline, 6 months, and 12 months
Title
Physical score of quality of life assessed by a validated patient-reported outcome scale
Description
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.
Time Frame
Baseline, 6 months, and 12 months
Title
Psychological score of quality of life assessed by a validated patient-reported outcome scale
Description
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.
Time Frame
Baseline, 6 months, and 12 months
Title
Family-social score of quality of life assessed by a validated patient-reported outcome scale
Description
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.
Time Frame
Baseline, 6 months, and 12 months
Title
Changes in fasting blood glucose (mg/dl)
Time Frame
Baseline, 6 months, and 12 months
Title
Changes in glycated hemoglobin (%)
Time Frame
Baseline, 6 months, and 12 months
Title
Changes in total cholesterol (mg/dl)
Time Frame
Baseline, 6 months, and 12 months
Title
Changes in triglycerides (mg/dl)
Time Frame
Baseline, 6 months, and 12 months
Title
Changes in low density lipoprotein cholesterol (mg/dl)
Time Frame
Baseline, 6 months, and 12 months
Title
Changes in high density lipoprotein cholesterol (mg/dl)
Time Frame
Baseline, 6 months, and 12 months
Title
Changes in urinary albumin (g/l)
Time Frame
Baseline, 6 months, and 12 months
Title
Changes in serum creatinine (μmol/l)
Time Frame
Baseline, 6 months, and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Meet the diagnostic criteria of primary hypertension
18 to 70 years old
Sign the informed consent
Exclusion Criteria:
Secondary hypertension caused by kidney disease, macrovascular disease, pregnancy, endocrine disease, brain disease, drug-induced factors, etc.
Allergic to moxibustion equipment, moxa smoke or moxa
Pregnancy or lactation
A history of serious cardiovascular and cerebrovascular events such as cerebrovascular accidents and myocardial infarction
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
Complicated by malignant tumors
Complicated by major mental disorders
Facility Information:
Facility Name
Jiangxi University of Traditional Chinese Medicine
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330004
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The individual participant data (IPD) of this study will be available from the principal investigator on reasonable request.
IPD Sharing Time Frame
After all results are published.
Citations:
PubMed Identifier
32957364
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.
Results Reference
derived
Learn more about this trial
Heat-sensitive Moxibustion Self-administration in Patients in the Community With Primary Hypertension: Protocol for a Multi-center, Pragmatic, Non-randomized Trial
We'll reach out to this number within 24 hrs