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临床试验/NCT04381520
NCT04381520Unknown不适用

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

Jiangxi University of Traditional Chinese Medicine1 个研究点 分布在 1 个国家目标入组 767 人开始时间: 2020年5月20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
发起方
入组人数
767
试验地点
1
主要终点
Changes in systolic blood pressure (mmHg)

研究概览

简要总结

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

详细描述

Primary hypertension is a global health issue with high incidence; it affected approximately 1.13 billion people worldwide and directly or indirectly causing an 10.4 million of death yearly. The routine drugs for primary hypertension are limited by adverse effects and expensive costs. Therefore, complementary and alternative medicine with good efficacy and safety and low expenditure is still needed for primary hypertension, especially in poverty-stricken areas.

Heat-sensitive moxibustion is an innovative therapy developed on the basis of traditional moxibustion. Compared with traditional moxibustion, heat-sensitive moxibustion advocates finding heat-sensitive acupoints where patients have special reactions to moxibustion heat, including diathermy, heat transfer, soreness, etc. The application of moxibustion on heat-sensitive acupoints (i.e., heat-sensitive moxibustion) has been shown to be more effective to traditional moxibustion for many diseases, including primary hypertension. Moreover, compared with acupuncture, heat-sensitive moxibustion has a main advantage that moxibustion does not require professional qualifications and patients can self-administer moxibustion after professional training. However, the current evidence is generated only from hospital settings. Therefore, this study is specifically designed to investigate whether heat-sensitive moxibustion self-administration is an effective intervention for lowering blood pressure and improving quality of life for patients with primary hypertension in community setting.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

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

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

排除标准

  • 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

研究组 & 干预措施

Heat-sensitive moxibustion plus antihypertensive drugs

Experimental

干预措施: Heat-sensitive moxibustion plus antihypertensive drugs (Other)

Antihypertensive drugs

Active Comparator

干预措施: Antihypertensive drugs (Drug)

结局指标

主要结局

Changes in systolic blood pressure (mmHg)

时间窗: Baseline, 6 months, and 12 months

Changes in diastolic blood pressure (mmHg)

时间窗: Baseline, 6 months, and 12 months

Changes in dose of antihypertensive drugs

时间窗: Baseline, 6 months, and 12 months

Measured by percentage changes

次要结局

  • 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)
  • Changes in glycated hemoglobin (%)(Baseline, 6 months, and 12 months)
  • Changes in total cholesterol (mg/dl)(Baseline, 6 months, and 12 months)
  • Changes in triglycerides (mg/dl)(Baseline, 6 months, and 12 months)
  • Changes in low density lipoprotein cholesterol (mg/dl)(Baseline, 6 months, and 12 months)
  • Changes in high density lipoprotein cholesterol (mg/dl)(Baseline, 6 months, and 12 months)
  • Changes in urinary albumin (g/l)(Baseline, 6 months, and 12 months)
  • Changes in serum creatinine (μmol/l)(Baseline, 6 months, and 12 months)

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 (1)

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