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

NCT04381520 | Unknown DMC

• 1 other identifier: JXUTCM-Mox-01
• Study Type: interventional
• Target: 767
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Primary Hypertension

Outcome Measures

Primary Outcomes (3)

• Changes in systolic blood pressure (mmHg)

  Baseline, 6 months, and 12 months

• Changes in diastolic blood pressure (mmHg)

  Baseline, 6 months, and 12 months

• Changes in dose of antihypertensive drugs

  Measured by percentage changes

  Baseline, 6 months, and 12 months

Secondary Outcomes (12)

• Total score of quality of life assessed by a validated patient-reported outcome scale

  Baseline, 6 months, and 12 months

• Physical score of quality of life assessed by a validated patient-reported outcome scale

  Baseline, 6 months, and 12 months

• Psychological score of quality of life assessed by a validated patient-reported outcome scale

  Baseline, 6 months, and 12 months

• Family-social score of quality of life assessed by a validated patient-reported outcome scale

  Baseline, 6 months, and 12 months

• Changes in fasting blood glucose (mg/dl)

  Baseline, 6 months, and 12 months

Study Arms (2)

Heat-sensitive moxibustion plus antihypertensive drugs

EXPERIMENTAL

Other: Heat-sensitive moxibustion plus antihypertensive drugs

Antihypertensive drugs

ACTIVE COMPARATOR

Drug: Antihypertensive drugs

Interventions

Heat-sensitive moxibustion plus antihypertensive drugs OTHER

In this arm, patients will administer heat-sensitive moxibustion by themselves or by the help of their family after professional training. Patients will maintain their original antihypertensive drugs. The periods of treatment and follow-up will be one year.

Heat-sensitive moxibustion plus antihypertensive drugs

Antihypertensive drugs DRUG

In this arm, patients will maintain their original antihypertensive drugs. The periods of treatment and follow-up will be one year.

Antihypertensive drugs

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jiangxi University of Traditional Chinese Medicine: lead
• Nangang community healthcare center (Nanchang city, Jiangxi province, China): collaborator
• Honggutan community healthcare center (Nanchang city, Jiangxi province, China): collaborator
• Shengmi community healthcare center (Nanchang city, Jiangxi province, China): collaborator
• Gaofu town community healthcare center (Fu Zhou city, Jiangxi province, China): collaborator

Study Sites (1)

Jiangxi University of Traditional Chinese Medicine

Nanchang, Jiangxi, 330004, China

Location

Related Publications (1)

• Zhou X, Wu Q, Zhang G, Wang Y, Li S, Wang B, Chen Z, Zhu W, Wang F, Gan C. Heat-sensitive moxibustion self-administration in patients in the community with primary hypertension: A protocol for a multi-center, pragmatic, non-randomized trial. Medicine (Baltimore). 2020 Sep 18;99(38):e22230. doi: 10.1097/MD.0000000000022230.

  PMID: 32957364 DERIVED

MeSH Terms

Conditions

Essential Hypertension

Interventions

Antihypertensive Agents

Condition Hierarchy (Ancestors)

Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cardiovascular Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: May 6, 2020
• First Posted: May 11, 2020
• Study Start: May 20, 2020
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: April 5, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: After all results are published.

Locations

CN (1)