A Randomized Patient Preference Trial on Heat-sensitive Moxibustion for Primary Hypertension in Community

July 2, 2024 updated by: Xu Zhou, Jiangxi University of Traditional Chinese Medicine

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
400

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangxi
      • Nanchang, Jiangxi, China, 330004
        • Erliuling
      • Nanchang, Jiangxi, China, 330004
        • Hongmiao
      • Nanchang, Jiangxi, China, 330004
        • Jinghexinggong community
      • Nanchang, Jiangxi, China, 330004
        • Jinsheng community
      • Nanchang, Jiangxi, China, 330004
        • Nangang community
      • Nanchang, Jiangxi, China, 330004
        • Shajing
      • Nanchang, Jiangxi, China, 330004
        • Wuliangdian community

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Diagnosed with essential hypertension, i.e., systolic blood pressure ≥ 140mmHg and/or diastolic blood pressure ≥ 90 mmHg, with a course more than 6 months.
  2. Ages: 18-80 years;
  3. The original antihypertensive drugs are calcium channel blockers and/or angiotensin II receptor blockers.
  4. Did not receive acupoint stimulation therapies for hypertension in the last month.
  5. 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.
  6. Consent to sign an informed consent form

Exclusion Criteria:

  1. Systolic blood pressure ≥ 180mmHg and/or diastolic blood pressure ≥ 110mmHg after taking antihypertensive drugs;
  2. Secondary hypertension.
  3. Pregnancy and lactation;
  4. Allergic to moxibustion devices, moxa smoke or Artemisia argyi.
  5. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Heat-sensitive moxibustion group A
In this group, patients are compulsively randomized to receive heat-sensitive moxibustion. They will maintain their original antihypertensive treatment (antihypertensive drugs or no treatment).
Other: 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.
Active Comparator: Control group A
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).
Drug: Original antihypertensive treatment (compulsively randomized arm)
In this group, patients will maintain their original antihypertensive treatment.
Experimental: Heat-sensitive moxibustion group B
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).
Other: 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.
Active Comparator: Control group B
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).
Drug: Original antihypertensive treatment (voluntarily randomized arm)
In this group, patients will maintain their original antihypertensive treatment.
Experimental: Heat-sensitive moxibustion group C
Patients who voluntarily choose to receive heat-sensitive moxibustion. They will maintain their original antihypertensive treatment (antihypertensive drugs or no treatment).
Other: 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.
Active Comparator: Control group C
Patients who voluntarily choose to not receive heat-sensitive moxibustion. They will maintain their original antihypertensive treatment (antihypertensive drugs or no treatment).
Drug: Original antihypertensive treatment (preference selection arm)
In this group, patients will maintain their original antihypertensive treatment.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Systolic blood pressure
Time Frame: Baseline and months 1, 2, 3, 4, 5, and 6
Changes from baseline in systolic blood pressure
Baseline and months 1, 2, 3, 4, 5, and 6

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Diastolic blood pressure
Time Frame: Baseline and months 1, 2, 3, 4, 5, and 6
Changes from baseline in diastolic blood pressure
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
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.
Baseline and months 1, 2, 3, 4, 5, and 6
Dose of antihypertensive drugs
Time Frame: Measure at baseline screening, monthly for 6 months
Changes from baseline in dose of antihypertensive drugs
Measure at baseline screening, monthly for 6 months
Score of EQ-5D-5L
Time Frame: Baseline and months 3 and 6
Quality of life will be measured using Euro-Qol-5 Dimensions-5 Levels questionnaire (EQ-5D-5L)
Baseline and months 3 and 6
Symptom score
Time Frame: Baseline and months 3 and 6
Symptoms will be scored using the scale in "Guiding Principles of Clinical Research on New Drugs of Chinese Medicines"
Baseline and months 3 and 6
Cost-effectiveness ratio
Time Frame: Baseline and months 1, 2, 3, 4, 5, and 6
Outpatient and inpatient costs for each group will be recorded and used to calculate the cost-effectiveness ratio
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
Patients' compliance will be assessed by recording the frequency and duration of heat-sensitive moxibustion.
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
Newly developed cardiovascular events
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
Adverse event data will be derived from patient self-reports and physician reviews.
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
Heat-sensitive moxibustion-related adverse event data will be derived from patient self-reports and physician reviews.
Baseline and months 1, 2, 3, 4, 5, and 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jiangxi University of Traditional Chinese Medicine

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Xu Zhou, M.D., Jiangxi University of Traditional Chinese Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 10, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 9, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 9, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 5, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 5, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 9, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 3, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 2, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • JXUTCM-Mox-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Primary Hypertension

Clinical Trials on Heat-sensitive moxibustion plus original antihypertensive treatment (compulsively randomized arm)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings