Primary HypertensionNCT04788563
A Randomized Patient Preference Trial on Heat-sensitive Moxibustion for Primary Hypertension in Community
A study testing Heat-sensitive moxibustion plus original antihypertensive treatment (compulsively randomized arm), Original antihypertensive treatment (compulsively randomized arm) and Heat-sensitive moxibustion plus antihypertensive treatment (voluntarily randomized arm) in people with Primary Hypertension, run by Jiangxi University of Traditional Chinese Medicine at 7 sites in China.
Trial summary
Heat-sensitive moxibustion, an important mean of external therapy of traditional Chinese medicine, has unique advantages in treating various chronic diseases than common moxibustion. 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 original antihypertensive treatment (compulsively randomized arm), Original antihypertensive treatment (compulsively randomized arm) and Heat-sensitive moxibustion plus antihypertensive treatment (voluntarily randomized arm)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 7 sitesChina
- Study dates
- 10 Mar 2021to 9 Dec 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
- Diagnosed with essential hypertension, i.e., systolic blood pressure ≥ 140mmHg and/or diastolic blood pressure ≥ 90 mmHg, with a course more than 6 months.
- Ages: 18-80 years;
- The original antihypertensive drugs are calcium channel blockers and/or angiotensin II receptor blockers.
- Did not receive acupoint stimulation therapies for hypertension in the last month.
- Patients in the heat-sensitive moxibustion groups need to develop at least one type of moxibustion sensation around the following acupoints: Yongquan, Baihui, Shenque, Quchi, Zusanli, Hegu, Taichong and Dazhui.
- Consent to sign an informed consent form
Who cannot join
- Systolic blood pressure ≥ 180mmHg and/or diastolic blood pressure ≥ 110mmHg after taking antihypertensive drugs;
- Secondary hypertension.
- Pregnancy and lactation;
- Allergic to moxibustion devices, moxa smoke or Artemisia argyi.
- Complicated with severe diseases that are not recommended for heat-sensitive moxibustion, such as acute cerebral hemorrhage, hypertensive crisis, sensory disturbances, serious mental diseases, etc.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
China7 sites
Erliuling
Nanchang, Jiangxi, 330004
Hongmiao
Nanchang, Jiangxi, 330004
Jinghexinggong community
Nanchang, Jiangxi, 330004
Jinsheng community
Nanchang, Jiangxi, 330004
Nangang community
Nanchang, Jiangxi, 330004
Shajing
Nanchang, Jiangxi, 330004
Wuliangdian community
Nanchang, Jiangxi, 330004
About this study
Official title: Heat-sensitive Moxibustion Self-administration for Primary Hypertension in Community: A Multicenter, Pragmatic, Randomized Controlled Trial With Patient Preference Arms
Heat-sensitive moxibustion, an important mean of external therapy of traditional Chinese medicine, has unique advantages in treating various chronic diseases than common moxibustion. This study aims to evaluate the efficacy, safety, and cost-effectiveness of heat-sensitive moxibustion for primary hypertension under community self-management setting using a multicenter, pragmatic, randomized controlled trial design with patient-preference arms.
Read the detailed description
Primary hypertension is a common chronic disease that threatens the life and health of human beings. The conventional western drug therapy often has side effects and many patients are unable to achieve ideal blood pressure control with drugs alone. Therefore, the treatment of primary hypertension still requires active exploration of complementary and alternative therapies with clear clinical efficacy.
Heat-sensitive moxibustion is an innovative moxibustion therapy. By stimulating the patient's special moxibustion sensation, heat-sensitive moxibustion can achieve better results than traditional moxibustion for many diseases, including primary hypertension. Heat-sensitive moxibustion is an easy, inexpensive and safe treatment method. The practitioner does not need to be professionally qualified to perform moxibustion, making it a suitable technique for patients to self-medicate on a daily basis. Traditional moxibustion has been shown to lower blood pressure in patients with primary hypertension. Theoretically, heat-sensitive moxibustion could achieve better blood pressure lowering effects, but its effects in lowering blood pressure in the setting of self-management in community patients is unclear. To verify the efficacy and safety of heat-sensitive moxibustion community self-management for hypertension, we plan to perform a randomized controlled trial. In this trial, we designed the trial grouping scheme as a randomized controlled trial with patient preference arms in order to improve patient adherence and reduce the impact of patient preference effects.
- Conditions
- Primary Hypertension
- Being tested
- Heat-sensitive moxibustion plus original antihypertensive treatment (compulsively randomized arm), Original antihypertensive treatment (compulsively randomized arm), Heat-sensitive moxibustion plus antihypertensive treatment (voluntarily randomized arm), Original antihypertensive treatment (voluntarily randomized arm), Heat-sensitive moxibustion plus original antihypertensive treatment (preference selection arm)
- 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 original antihypertensive treatment (compulsively randomized arm)Other
In this group, patients will self-administer heat-sensitive moxibustion or have family members help with the administration for six months. During this period, they will maintain their original antihypertensive treatment.
Original antihypertensive treatment (compulsively randomized arm)Drug
In this group, patients will maintain their original antihypertensive treatment.
Heat-sensitive moxibustion plus antihypertensive treatment (voluntarily randomized arm)Other
In this group, patients will self-administer heat-sensitive moxibustion or have family members help with the administration for six months. During this period, they will maintain their original antihypertensive treatment.
Original antihypertensive treatment (voluntarily randomized arm)Drug
In this group, patients will maintain their original antihypertensive treatment.
Heat-sensitive moxibustion plus original antihypertensive treatment (preference selection arm)Other
In this group, patients will self-administer heat-sensitive moxibustion or have family members help with the administration for six months. During this period, they will maintain their original antihypertensive treatment.
Original antihypertensive treatment (preference selection arm)Drug
In this group, patients will maintain their original antihypertensive treatment.
| Study group | Role | What they receive |
|---|---|---|
| Heat-sensitive moxibustion group A | Experimental | In this group, patients are compulsively randomized to receive heat-sensitive moxibustion. They will maintain their original antihypertensive treatment (antihypertensive drugs or no treatment). Receives: Other: Heat-sensitive moxibustion plus original antihypertensive treatment (compulsively randomized arm) |
| Control group A | Active comparator | In this group, patients are compulsively randomized to not receive heat-sensitive moxibustion. They will maintain their original antihypertensive treatment (antihypertensive drugs or no treatment). Receives: Drug: Original antihypertensive treatment (compulsively randomized arm) |
| Heat-sensitive moxibustion group B | Experimental | Patients who voluntarily choose to receive randomization and are randomly assigned to receive heat-sensitive moxibustion. They will maintain their original antihypertensive treatment (antihypertensive drugs or no treatment). Receives: Other: Heat-sensitive moxibustion plus antihypertensive treatment (voluntarily randomized arm) |
| Control group B | Active comparator | Patients who voluntarily choose to receive randomization and are randomly assigned to not receive heat-sensitive moxibustion. They will maintain their original antihypertensive treatment (antihypertensive drugs or no treatment). Receives: Drug: Original antihypertensive treatment (voluntarily randomized arm) |
| Heat-sensitive moxibustion group C | Experimental | Patients who voluntarily choose to receive heat-sensitive moxibustion. They will maintain their original antihypertensive treatment (antihypertensive drugs or no treatment). Receives: Other: Heat-sensitive moxibustion plus original antihypertensive treatment (preference selection arm) |
| Control group C | Active comparator | Patients who voluntarily choose to not receive heat-sensitive moxibustion. They will maintain their original antihypertensive treatment (antihypertensive drugs or no treatment). Receives: Drug: Original antihypertensive treatment (preference selection arm) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic blood pressure
Changes from baseline in systolic blood pressure
Measured: Baseline and months 1, 2, 3, 4, 5, and 6
Secondary outcomes (10)
Diastolic blood pressure
Changes from baseline in diastolic blood pressure
Measured: Baseline and months 1, 2, 3, 4, 5, and 6
Response to treatment
Definition: (i) a decrease in systolic blood pressure ≥ 20 mmHg or diastolic blood pressure ≥ 10 mmHg; or (ii) blood pressure control of < 140 mmHg systolic and < 90 mmHg diastolic in patients aged ≥ 65 years; blood pressure control of < 130 mmHg systolic and < 80 mmHg diastolic in patients aged < 65 years.
Measured: Baseline and months 1, 2, 3, 4, 5, and 6
Dose of antihypertensive drugs
Changes from baseline in dose of antihypertensive drugs
Measured: Measure at baseline screening, monthly for 6 months
Score of EQ-5D-5L
Quality of life will be measured using Euro-Qol-5 Dimensions-5 Levels questionnaire (EQ-5D-5L)
Measured: Baseline and months 3 and 6
Symptom score
Symptoms will be scored using the scale in "Guiding Principles of Clinical Research on New Drugs of Chinese Medicines"
Measured: Baseline and months 3 and 6
Cost-effectiveness ratio
Outpatient and inpatient costs for each group will be recorded and used to calculate the cost-effectiveness ratio
Measured: Baseline and months 1, 2, 3, 4, 5, and 6
Patients' compliance to heat-sensitive moxibustion
Patients' compliance will be assessed by recording the frequency and duration of heat-sensitive moxibustion.
Measured: Baseline and months 1, 2, 3, 4, 5, and 6
Incidence of cardiovascular events
Newly developed cardiovascular events
Measured: Baseline and months 1, 2, 3, 4, 5, and 6
Any adverse events
Adverse event data will be derived from patient self-reports and physician reviews.
Measured: Baseline and months 1, 2, 3, 4, 5, and 6
Heat-sensitive moxibustion-related adverse events
Heat-sensitive moxibustion-related adverse event data will be derived from patient self-reports and physician reviews.
Measured: Baseline and months 1, 2, 3, 4, 5, and 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2021
- Study start10 Mar 2021
- Primary completion9 Dec 2021
- Study completion9 Dec 2021
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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial with patient preference arms
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangxi University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xu Zhou, Jiangxi University of Traditional Chinese Medicine
- Investigators
- Xu Zhou, M.D., Principal investigator, Jiangxi University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04788563
- Sponsor's protocol ID
- JXUTCM-Mox-02
- Status last verified
- Jul 2024
- First submitted
- 5 Mar 2021
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhou X, Li S, Li L, Deng G, Dai L, Chai L, Wu Q, Yao Z, Deng M, Zhu W, Fu Y, Sun X. Community-based heat-sensitive moxibustion for primary hypertension: study protocol for a randomized controlled trial with patient-preference arms. Trials. 2022 Feb 16;23(1):154. doi: 10.1186/s13063-022-06092-4.
PubMed 35172871
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heat-sensitive Moxibustion Self-administration for Primary Hypertension in Community: A Multicenter, Pragmatic, Randomized Controlled Trial With Patient Preference Arms
- ClinicalTrials.gov ID
- NCT04788563
- Acronym / sponsor ID
- JXUTCM-Mox-02
- Conditions
- Primary Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Jiangxi University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 10 Mar 2021 (actual)
- Primary completion
- 9 Dec 2021 (actual)
- Study completion
- 9 Dec 2021 (actual)
- First posted
- 9 Mar 2021 (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, an important mean of external therapy of traditional Chinese medicine, has unique advantages in treating various chronic diseases than common moxibustion. This study aims to evaluate the efficacy, safety, and cost-effectiveness of heat-sensitive moxibustion for primary hypertension under community self-management setting using a multicenter, pragmatic, randomized controlled trial design with patient-preference arms.
Detailed description
Primary hypertension is a common chronic disease that threatens the life and health of human beings. The conventional western drug therapy often has side effects and many patients are unable to achieve ideal blood pressure control with drugs alone. Therefore, the treatment of primary hypertension still requires active exploration of complementary and alternative therapies with clear clinical efficacy.
Heat-sensitive moxibustion is an innovative moxibustion therapy. By stimulating the patient's special moxibustion sensation, heat-sensitive moxibustion can achieve better results than traditional moxibustion for many diseases, including primary hypertension. Heat-sensitive moxibustion is an easy, inexpensive and safe treatment method. The practitioner does not need to be professionally qualified to perform moxibustion, making it a suitable technique for patients to self-medicate on a daily basis. Traditional moxibustion has been shown to lower blood pressure in patients with primary hypertension. Theoretically, heat-sensitive moxibustion could achieve better blood pressure lowering effects, but its effects in lowering blood pressure in the setting of self-management in community patients is unclear. To verify the efficacy and safety of heat-sensitive moxibustion community self-management for hypertension, we plan to perform a randomized controlled trial. In this trial, we designed the trial grouping scheme as a randomized controlled trial with patient preference arms in order to improve patient adherence and reduce the impact of patient preference effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 6
- Model description
- Randomized controlled trial with patient preference arms
| Arm | Type | Receives |
|---|---|---|
| Heat-sensitive moxibustion group A | Experimental | Other: Heat-sensitive moxibustion plus original antihypertensive treatment (compulsively randomized arm)In this group, patients are compulsively randomized to receive heat-sensitive moxibustion. They will maintain their original antihypertensive treatment (antihypertensive drugs or no treatment). |
| Control group A | Active comparator | Drug: Original antihypertensive treatment (compulsively randomized arm)In this group, patients are compulsively randomized to not receive heat-sensitive moxibustion. They will maintain their original antihypertensive treatment (antihypertensive drugs or no treatment). |
| Heat-sensitive moxibustion group B | Experimental | Other: Heat-sensitive moxibustion plus antihypertensive treatment (voluntarily randomized arm)Patients who voluntarily choose to receive randomization and are randomly assigned to receive heat-sensitive moxibustion. They will maintain their original antihypertensive treatment (antihypertensive drugs or no treatment). |
| Control group B | Active comparator | Drug: Original antihypertensive treatment (voluntarily randomized arm)Patients who voluntarily choose to receive randomization and are randomly assigned to not receive heat-sensitive moxibustion. They will maintain their original antihypertensive treatment (antihypertensive drugs or no treatment). |
| Heat-sensitive moxibustion group C | Experimental | Other: Heat-sensitive moxibustion plus original antihypertensive treatment (preference selection arm)Patients who voluntarily choose to receive heat-sensitive moxibustion. They will maintain their original antihypertensive treatment (antihypertensive drugs or no treatment). |
| Control group C | Active comparator | Drug: Original antihypertensive treatment (preference selection arm)Patients who voluntarily choose to not receive heat-sensitive moxibustion. They will maintain their original antihypertensive treatment (antihypertensive drugs or no treatment). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosed with essential hypertension, i.e., systolic blood pressure ≥ 140mmHg and/or diastolic blood pressure ≥ 90 mmHg, with a course more than 6 months.
- Ages: 18-80 years;
- The original antihypertensive drugs are calcium channel blockers and/or angiotensin II receptor blockers.
- Did not receive acupoint stimulation therapies for hypertension in the last month.
- Patients in the heat-sensitive moxibustion groups need to develop at least one type of moxibustion sensation around the following acupoints: Yongquan, Baihui, Shenque, Quchi, Zusanli, Hegu, Taichong and Dazhui.
Key exclusion criteria (5 listed)
- Systolic blood pressure ≥ 180mmHg and/or diastolic blood pressure ≥ 110mmHg after taking antihypertensive drugs;
- Secondary hypertension.
- Pregnancy and lactation;
- Allergic to moxibustion devices, moxa smoke or Artemisia argyi.
- Complicated with severe diseases that are not recommended for heat-sensitive moxibustion, such as acute cerebral hemorrhage, hypertensive crisis, sensory disturbances, serious mental diseases, etc.
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 original antihypertensive treatment (compulsively randomized arm)In this group, patients will self-administer heat-sensitive moxibustion or have family members help with the administration for six months. During this period, they will maintain their original antihypertensive treatment. | Other | Heat-sensitive moxibustion group A |
| Original antihypertensive treatment (compulsively randomized arm)In this group, patients will maintain their original antihypertensive treatment. | Drug | Control group A |
| Heat-sensitive moxibustion plus antihypertensive treatment (voluntarily randomized arm)In this group, patients will self-administer heat-sensitive moxibustion or have family members help with the administration for six months. During this period, they will maintain their original antihypertensive treatment. | Other | Heat-sensitive moxibustion group B |
| Original antihypertensive treatment (voluntarily randomized arm)In this group, patients will maintain their original antihypertensive treatment. | Drug | Control group B |
| Heat-sensitive moxibustion plus original antihypertensive treatment (preference selection arm)In this group, patients will self-administer heat-sensitive moxibustion or have family members help with the administration for six months. During this period, they will maintain their original antihypertensive treatment. | Other | Heat-sensitive moxibustion group C |
| Original antihypertensive treatment (preference selection arm)In this group, patients will maintain their original antihypertensive treatment. | Drug | Control group C |
Primary outcome
Systolic blood pressure
Time frame: Baseline and months 1, 2, 3, 4, 5, and 6
Changes from baseline in systolic blood pressure
10 secondary outcomes
Diastolic blood pressure
Time frame: Baseline and months 1, 2, 3, 4, 5, and 6
Response to treatment
Time frame: Baseline and months 1, 2, 3, 4, 5, and 6
Dose of antihypertensive drugs
Time frame: Measure at baseline screening, monthly for 6 months
Score of EQ-5D-5L
Time frame: Baseline and months 3 and 6
Symptom score
Time frame: Baseline and months 3 and 6
Cost-effectiveness ratio
Time frame: Baseline and months 1, 2, 3, 4, 5, and 6
Patients' compliance to heat-sensitive moxibustion
Time frame: Baseline and months 1, 2, 3, 4, 5, and 6
Incidence of cardiovascular events
Time frame: Baseline and months 1, 2, 3, 4, 5, and 6
Any adverse events
Time frame: Baseline and months 1, 2, 3, 4, 5, and 6
Heat-sensitive moxibustion-related adverse events
Time frame: Baseline and months 1, 2, 3, 4, 5, and 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Derived from this study: PubMed 35172871Zhou X, Li S, Li L, Deng G, Dai L, Chai L, Wu Q, Yao Z, Deng M, Zhu W, Fu Y, Sun X. Community-based heat-sensitive moxibustion for primary hypertension: study protocol for a randomized controlled trial with patient-preference arms. Trials. 2022 Feb 16;23(1):154. doi: 10.1186/s13063-022-06092-4.
- Individual participant dataSharing planned: No
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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.
Xu Zhou, M.D. principal investigator
Jiangxi University of Traditional Chinese Medicine
7 sites 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 original antihypertensive treatment (compulsively randomized arm), Original antihypertensive treatment (compulsively randomized arm) and Heat-sensitive moxibustion plus antihypertensive treatment (voluntarily randomized arm) in people with Primary Hypertension, run by Jiangxi University of Traditional Chinese Medicine at 7 sites 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 6 inclusion and 5 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: finished, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Systolic blood pressure (time frame: Baseline and months 1, 2, 3, 4, 5, and 6). 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 NCT04788563, 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 3 Jul 2024.