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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 range18 Years – 80 Years

SexALL

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
✕. Complicated by liver and kidney dysfunction indicated by total bilirubin, alanine aminotransferase, aspartate aminotransferase, or blood creatinine are more than 2 times upper limit of normal value
✕. Complicated by malignant tumors
✕. Complicated by major mental disorders

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 range18 Years – 80 Years

SexALL

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
✕. Complicated by liver and kidney dysfunction indicated by total bilirubin, alanine aminotransferase, aspartate aminotransferase, or blood creatinine are more than 2 times upper limit of normal value
✕. Complicated by malignant tumors
✕. Complicated by major mental disorders