UnknownNot Applicable

Heat-sensitive Moxibustion Self-administration in Patients in the Community With Primary Hypertension: Protocol for a Multi-center, Pragmatic, Non-randomized Trial

China767 participantsStarted 2020-05-20

Plain-language 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 using a multicenter, prospective, non-randomized study design

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Meet the diagnostic criteria of primary hypertension
. 18 to 70 years old
. Sign the informed consent

Exclusion criteria

. 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Changes in systolic blood pressure (mmHg)

Timeframe: Baseline, 6 months, and 12 months

Changes in diastolic blood pressure (mmHg)

Timeframe: Baseline, 6 months, and 12 months

Changes in dose of antihypertensive drugs

Timeframe: Baseline, 6 months, and 12 months

Trial details

NCT IDNCT04381520

SponsorJiangxi University of Traditional Chinese Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-06-30

View on ClinicalTrials.gov More Primary Hypertension trials

Plain-language summary

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Meet the diagnostic criteria of primary hypertension
. 18 to 70 years old
. Sign the informed consent

Exclusion criteria

. 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