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临床试验/NCT04788563
NCT04788563已完成不适用

Heat-sensitive Moxibustion Self-administration for Primary Hypertension in Community: A Multicenter, Pragmatic, Randomized Controlled Trial With Patient Preference Arms

Jiangxi University of Traditional Chinese Medicine7 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2021年3月10日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
400
试验地点
7
主要终点
Systolic blood pressure

研究概览

简要总结

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.

详细描述

Primary hypertension is a common chronic disease that threatens the life and health of human beings. The conventional western drug therapy often has side effects and many patients are unable to achieve ideal blood pressure control with drugs alone. Therefore, the treatment of primary hypertension still requires active exploration of complementary and alternative therapies with clear clinical efficacy.

Heat-sensitive moxibustion is an innovative moxibustion therapy. By stimulating the patient's special moxibustion sensation, heat-sensitive moxibustion can achieve better results than traditional moxibustion for many diseases, including primary hypertension. Heat-sensitive moxibustion is an easy, inexpensive and safe treatment method. The practitioner does not need to be professionally qualified to perform moxibustion, making it a suitable technique for patients to self-medicate on a daily basis. Traditional moxibustion has been shown to lower blood pressure in patients with primary hypertension. Theoretically, heat-sensitive moxibustion could achieve better blood pressure lowering effects, but its effects in lowering blood pressure in the setting of self-management in community patients is unclear. To verify the efficacy and safety of heat-sensitive moxibustion community self-management for hypertension, we plan to perform a randomized controlled trial. In this trial, we designed the trial grouping scheme as a randomized controlled trial with patient preference arms in order to improve patient adherence and reduce the impact of patient preference effects.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

Data analysts will be blinded.

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

研究组 & 干预措施

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).

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

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).

干预措施: Original antihypertensive treatment (compulsively randomized arm) (Drug)

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).

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

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).

干预措施: Original antihypertensive treatment (voluntarily randomized arm) (Drug)

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).

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

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).

干预措施: Original antihypertensive treatment (preference selection arm) (Drug)

结局指标

主要结局

Systolic blood pressure

时间窗: Baseline and months 1, 2, 3, 4, 5, and 6

Changes from baseline in systolic blood pressure

次要结局

  • 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)
  • Cost-effectiveness ratio(Baseline and months 1, 2, 3, 4, 5, and 6)
  • Diastolic blood pressure(Baseline and months 1, 2, 3, 4, 5, and 6)
  • Patients' compliance to heat-sensitive moxibustion(Baseline and months 1, 2, 3, 4, 5, and 6)
  • Any adverse events(Baseline and months 1, 2, 3, 4, 5, and 6)
  • Heat-sensitive moxibustion-related adverse events(Baseline and months 1, 2, 3, 4, 5, and 6)
  • Incidence of cardiovascular events(Baseline and months 1, 2, 3, 4, 5, and 6)

研究者

发起方
Jiangxi University of Traditional Chinese Medicine
申办方类型
Other
责任方
Principal Investigator
主要研究者

Xu Zhou

Associate professor

Jiangxi University of Traditional Chinese Medicine

研究点 (7)

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