NCT04788563

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 5, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 9, 2021

Completed
1 day until next milestone

Study Start

First participant enrolled

March 10, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 9, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 9, 2021

Completed
Last Updated

July 3, 2024

Status Verified

July 1, 2024

Enrollment Period

9 months

First QC Date

March 5, 2021

Last Update Submit

July 2, 2024

Conditions

Primary Hypertension

Outcome Measures

Primary Outcomes (1)

  • Systolic blood pressure

    Changes from baseline in systolic blood pressure

    Baseline and months 1, 2, 3, 4, 5, and 6

Secondary Outcomes (10)

  • Diastolic blood pressure

    Baseline and months 1, 2, 3, 4, 5, and 6

  • Response to treatment

    Baseline and months 1, 2, 3, 4, 5, and 6

  • Dose of antihypertensive drugs

    Measure at baseline screening, monthly for 6 months

  • Score of EQ-5D-5L

    Baseline and months 3 and 6

  • Symptom score

    Baseline and months 3 and 6

  • +5 more secondary outcomes

Study Arms (6)

Heat-sensitive moxibustion group A

EXPERIMENTAL

In this group, patients are compulsively randomized to receive heat-sensitive moxibustion. They will maintain their original antihypertensive treatment (antihypertensive drugs or no treatment).

Other: Heat-sensitive moxibustion plus original antihypertensive treatment (compulsively randomized arm)

Control group A

ACTIVE COMPARATOR

In this group, patients are compulsively randomized to not receive heat-sensitive moxibustion. They will maintain their original antihypertensive treatment (antihypertensive drugs or no treatment).

Drug: Original antihypertensive treatment (compulsively randomized arm)

Heat-sensitive moxibustion group B

EXPERIMENTAL

Patients who voluntarily choose to receive randomization and are randomly assigned to receive heat-sensitive moxibustion. They will maintain their original antihypertensive treatment (antihypertensive drugs or no treatment).

Other: Heat-sensitive moxibustion plus antihypertensive treatment (voluntarily randomized arm)

Control group B

ACTIVE COMPARATOR

Patients who voluntarily choose to receive randomization and are randomly assigned to not receive heat-sensitive moxibustion. They will maintain their original antihypertensive treatment (antihypertensive drugs or no treatment).

Drug: Original antihypertensive treatment (voluntarily randomized arm)

Heat-sensitive moxibustion group C

EXPERIMENTAL

Patients who voluntarily choose to receive heat-sensitive moxibustion. They will maintain their original antihypertensive treatment (antihypertensive drugs or no treatment).

Other: Heat-sensitive moxibustion plus original antihypertensive treatment (preference selection arm)

Control group C

ACTIVE COMPARATOR

Patients who voluntarily choose to not receive heat-sensitive moxibustion. They will maintain their original antihypertensive treatment (antihypertensive drugs or no treatment).

Drug: Original antihypertensive treatment (preference selection arm)

Interventions

Heat-sensitive moxibustion plus original antihypertensive treatment (compulsively randomized arm)OTHER

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.

Heat-sensitive moxibustion group A
Original antihypertensive treatment (compulsively randomized arm)DRUG

In this group, patients will maintain their original antihypertensive treatment.

Control group A
Heat-sensitive moxibustion plus antihypertensive treatment (voluntarily randomized arm)OTHER

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.

Heat-sensitive moxibustion group B
Original antihypertensive treatment (voluntarily randomized arm)DRUG

In this group, patients will maintain their original antihypertensive treatment.

Control group B
Heat-sensitive moxibustion plus original antihypertensive treatment (preference selection arm)OTHER

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.

Heat-sensitive moxibustion group C
Original antihypertensive treatment (preference selection arm)DRUG

In this group, patients will maintain their original antihypertensive treatment.

Control group C

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed with essential hypertension, i.e., systolic blood pressure ≥ 140mmHg and/or diastolic blood pressure ≥ 90 mmHg, with a course more than 6 months.
  • Ages: 18-80 years;
  • The original antihypertensive drugs are calcium channel blockers and/or angiotensin II receptor blockers.
  • Did not receive acupoint stimulation therapies for hypertension in the last month.
  • 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.
  • Consent to sign an informed consent form

You may not qualify if:

  • Systolic blood pressure ≥ 180mmHg and/or diastolic blood pressure ≥ 110mmHg after taking antihypertensive drugs;
  • Secondary hypertension.
  • Pregnancy and lactation;
  • Allergic to moxibustion devices, moxa smoke or Artemisia argyi.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Erliuling

Nanchang, Jiangxi, 330004, China

Location

Hongmiao

Nanchang, Jiangxi, 330004, China

Location

Jinghexinggong community

Nanchang, Jiangxi, 330004, China

Location

Jinsheng community

Nanchang, Jiangxi, 330004, China

Location

Nangang community

Nanchang, Jiangxi, 330004, China

Location

Shajing

Nanchang, Jiangxi, 330004, China

Location

Wuliangdian community

Nanchang, Jiangxi, 330004, China

Location

Related Publications (1)

  • Zhou X, Li S, Li L, Deng G, Dai L, Chai L, Wu Q, Yao Z, Deng M, Zhu W, Fu Y, Sun X. Community-based heat-sensitive moxibustion for primary hypertension: study protocol for a randomized controlled trial with patient-preference arms. Trials. 2022 Feb 16;23(1):154. doi: 10.1186/s13063-022-06092-4.

    PMID: 35172871DERIVED

MeSH Terms

Conditions

Essential Hypertension

Condition Hierarchy (Ancestors)

HypertensionVascular DiseasesCardiovascular Diseases

Study Officials

  • Xu Zhou, M.D.

    Jiangxi University of Traditional Chinese Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Data analysts will be blinded.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized controlled trial with patient preference arms
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

March 5, 2021

First Posted

March 9, 2021

Study Start

March 10, 2021

Primary Completion

December 9, 2021

Study Completion

December 9, 2021

Last Updated

July 3, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(7)