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

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.

Conditions

• Primary Hypertension

Interventions

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.

Sponsors & Collaborators

• Jiangxi University of Traditional Chinese Medicine

  lead OTHER

Principal Investigators

• Xu Zhou, M.D. · Jiangxi University of Traditional Chinese Medicine

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-03-10

Primary Completion

2021-12-09

Completion

2021-12-09

Countries

• China

Study Locations