Primary HypertensionNCT04381520
Heat-sensitive Moxibustion Self-administration in Patients in the Community With Primary Hypertension: Protocol for a Multi-center, Pragmatic, Non-randomized Trial
A study testing Heat-sensitive moxibustion plus antihypertensive drugs and Antihypertensive drugs in people with Primary Hypertension, run by Jiangxi University of Traditional Chinese Medicine at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Primary Hypertension
- What is being tested?
- Heat-sensitive moxibustion plus antihypertensive drugs and Antihypertensive drugs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 767 participants
- Where
- 1 siteChina
- Study dates
- 20 May 2020to 30 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meet the diagnostic criteria of primary hypertension
- 18 to 70 years old
- Sign the informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Jiangxi University of Traditional Chinese Medicine
Nanchang, Jiangxi, 330004
About this study
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
Read the 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
- Being tested
- Heat-sensitive moxibustion plus antihypertensive drugs, Antihypertensive drugs
- Medical subject headings
- Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heat-sensitive moxibustion plus antihypertensive drugsOther
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 drugsDrug
In this arm, patients will maintain their original antihypertensive drugs. The periods of treatment and follow-up will be one year.
| Study group | Role | What they receive |
|---|---|---|
| Heat-sensitive moxibustion plus antihypertensive drugs | Experimental | Not described Receives: Other: Heat-sensitive moxibustion plus antihypertensive drugs |
| Antihypertensive drugs | Active comparator | Not described Receives: Drug: Antihypertensive drugs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in systolic blood pressure (mmHg)
Measured: Baseline, 6 months, and 12 months
Changes in diastolic blood pressure (mmHg)
Measured: Baseline, 6 months, and 12 months
Changes in dose of antihypertensive drugs
Measured by percentage changes
Measured: Baseline, 6 months, and 12 months
Secondary outcomes (12)
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.
Measured: Baseline, 6 months, and 12 months
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.
Measured: Baseline, 6 months, and 12 months
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.
Measured: Baseline, 6 months, and 12 months
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.
Measured: Baseline, 6 months, and 12 months
Changes in fasting blood glucose (mg/dl)
Measured: Baseline, 6 months, and 12 months
Changes in glycated hemoglobin (%)
Measured: Baseline, 6 months, and 12 months
Changes in total cholesterol (mg/dl)
Measured: Baseline, 6 months, and 12 months
Changes in triglycerides (mg/dl)
Measured: Baseline, 6 months, and 12 months
Changes in low density lipoprotein cholesterol (mg/dl)
Measured: Baseline, 6 months, and 12 months
Changes in high density lipoprotein cholesterol (mg/dl)
Measured: Baseline, 6 months, and 12 months
Changes in urinary albumin (g/l)
Measured: Baseline, 6 months, and 12 months
Changes in serum creatinine (μmol/l)
Measured: Baseline, 6 months, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2020
- Study start20 May 2020
- Primary completion30 Jun 2021 (estimated)
- Study completion30 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 767 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangxi University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- 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)
- Responsible party
- Principal investigator, Xu Zhou, Jiangxi University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04381520
- Sponsor's protocol ID
- JXUTCM-Mox-01
- Status last verified
- Apr 2021
- First submitted
- 6 May 2020
- Last updated
- 5 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The individual participant data (IPD) of this study will be available from the principal investigator on reasonable request.
Publications
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.
PubMed 32957364
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heat-sensitive Moxibustion Self-administration in Patients in the Community With Primary Hypertension: Protocol for a Multi-center, Pragmatic, Non-randomized Trial
- ClinicalTrials.gov ID
- NCT04381520
- Acronym / sponsor ID
- JXUTCM-Mox-01
- Conditions
- Primary Hypertension
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 767 participants (actual)
- Lead sponsor
- Jiangxi University of Traditional Chinese MedicineUniversity, hospital or other
- 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)
- Study start
- 20 May 2020 (actual)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 11 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Heat-sensitive moxibustion plus antihypertensive drugs | Experimental | Other: Heat-sensitive moxibustion plus antihypertensive drugs |
| Antihypertensive drugs | Active comparator | Drug: Antihypertensive drugs |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Meet the diagnostic criteria of primary hypertension
- 18 to 70 years old
- Sign the informed consent
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heat-sensitive moxibustion plus antihypertensive drugsIn 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. | Other | Heat-sensitive moxibustion plus antihypertensive drugs |
| Antihypertensive drugsIn this arm, patients will maintain their original antihypertensive drugs. The periods of treatment and follow-up will be one year. | Drug | Antihypertensive drugs |
Primary outcome
Changes in systolic blood pressure (mmHg)
Time frame: Baseline, 6 months, and 12 months
Changes in diastolic blood pressure (mmHg)
Time frame: Baseline, 6 months, and 12 months
Changes in dose of antihypertensive drugs
Time frame: Baseline, 6 months, and 12 months
Measured by percentage changes
12 secondary outcomes
Total score of quality of life assessed by a validated patient-reported outcome scale
Time frame: Baseline, 6 months, and 12 months
Physical score of quality of life assessed by a validated patient-reported outcome scale
Time frame: Baseline, 6 months, and 12 months
Psychological score of quality of life assessed by a validated patient-reported outcome scale
Time frame: Baseline, 6 months, and 12 months
Family-social score of quality of life assessed by a validated patient-reported outcome scale
Time frame: Baseline, 6 months, and 12 months
Changes in fasting blood glucose (mg/dl)
Time frame: Baseline, 6 months, and 12 months
Changes in glycated hemoglobin (%)
Time frame: Baseline, 6 months, and 12 months
Changes in total cholesterol (mg/dl)
Time frame: Baseline, 6 months, and 12 months
Changes in triglycerides (mg/dl)
Time frame: Baseline, 6 months, and 12 months
Changes in low density lipoprotein cholesterol (mg/dl)
Time frame: Baseline, 6 months, and 12 months
Changes in high density lipoprotein cholesterol (mg/dl)
Time frame: Baseline, 6 months, and 12 months
Changes in urinary albumin (g/l)
Time frame: Baseline, 6 months, and 12 months
Changes in serum creatinine (μmol/l)
Time frame: Baseline, 6 months, and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2021.
- Derived from this study: PubMed 32957364Zhou 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.
- Individual participant dataSharing planned: Yes. The individual participant data (IPD) of this study will be available from the principal investigator on reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heat-sensitive moxibustion plus antihypertensive drugs and Antihypertensive drugs in people with Primary Hypertension, run by Jiangxi University of Traditional Chinese Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in systolic blood pressure (mmHg) (time frame: Baseline, 6 months, and 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04381520, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2021.