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

Primary Hypertension Clinical Trial

Official title:

Heat-sensitive Moxibustion Self-administration for Primary Hypertension in Community: A Multicenter, Pragmatic, Randomized Controlled Trial With Patient Preference Arms

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04788563
• Other study ID #: JXUTCM-Mox-02
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 10, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: January 2022
• Source: Jiangxi University of Traditional Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 400
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Essential Hypertension
• Hypertension
• Primary Hypertension

Intervention

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.

Drug:
• Original antihypertensive treatment (compulsively randomized arm)
In this group, patients will maintain their original antihypertensive 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.

Drug:
• Original antihypertensive treatment (voluntarily randomized arm)
In this group, patients will maintain their original antihypertensive 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.

Drug:
• Original antihypertensive treatment (preference selection arm)
In this group, patients will maintain their original antihypertensive treatment.

Locations

Country	Name	City	State
China	Erliuling	Nanchang	Jiangxi
China	Hongmiao	Nanchang	Jiangxi
China	Jinghexinggong community	Nanchang	Jiangxi
China	Jinsheng community	Nanchang	Jiangxi
China	Nangang community	Nanchang	Jiangxi
China	Shajing	Nanchang	Jiangxi
China	Wuliangdian community	Nanchang	Jiangxi

Sponsors (1)

Lead Sponsor	Collaborator
Jiangxi University of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Systolic blood pressure	Changes from baseline in systolic blood pressure	Baseline and months 1, 2, 3, 4, 5, and 6
Secondary	Diastolic blood pressure	Changes from baseline in diastolic blood pressure	Baseline and months 1, 2, 3, 4, 5, and 6
Secondary	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.	Baseline and months 1, 2, 3, 4, 5, and 6
Secondary	Dose of antihypertensive drugs	Changes from baseline in dose of antihypertensive drugs	Measure at baseline screening, monthly for 6 months
Secondary	Score of EQ-5D-5L	Quality of life will be measured using Euro-Qol-5 Dimensions-5 Levels questionnaire (EQ-5D-5L)	Baseline and months 3 and 6
Secondary	Symptom score	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
Secondary	Cost-effectiveness ratio	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
Secondary	Patients' compliance to heat-sensitive moxibustion	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
Secondary	Incidence of cardiovascular events	Newly developed cardiovascular events	Baseline and months 1, 2, 3, 4, 5, and 6
Secondary	Any adverse events	Adverse event data will be derived from patient self-reports and physician reviews.	Baseline and months 1, 2, 3, 4, 5, and 6
Secondary	Heat-sensitive moxibustion-related adverse events	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