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临床试验/NCT04505228
NCT04505228已完成不适用

The Personalized Chinese Herb Formulas Are Evaluated for Their Effectiveness to Relieve Symptoms in Hypertensive Bradyarrhythmia

Jun Xiao1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2020年1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
状态
已完成
发起方
入组人数
72
试验地点
1
主要终点
typical symptoms in patients with hypertensive bradyarrhythmia

研究概览

简要总结

72 patients who have been diagnosed with hypertensive bradyarrhythmia were selected and randomly divided into research group and control group. The research group received regular medication against hypertension and the personalized formulas based on syndrome differentiation, meanwhile the control group only received the regular medication. The five symptoms (palpitation, short of breath, angina, dizzy and lumbar debility) were graded and used for evaluation of treatment.

详细描述

To test the effect of Chinese herb against the hypertensive heart disease, we designed this randomized controlled clinical trial. 72 patients who have been diagnosed with hypertensive bradyarrhythmia were selected and randomly divided into research group and control group. The five symptoms (palpitation, short of breath, angina, dizzy and lumbar debility) were graded. The research group received regular medication against hypertension and the personalized formulas based on syndrome differentiation, meanwhile the control group only received the regular medication. 2 weeks after treatment, all the symptoms were graded again.

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
Single (Outcomes Assessor)

入排标准

年龄范围
20 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • * Clinical diagnosis of hypertensive bradyarhhythmia

排除标准

  • With other elementary diseases
  • With pregnant
  • With receiving other treatment within past half year from the beginning of trial.

研究组 & 干预措施

Control group

Active Comparator

The patients receiving the basic treatment of atropine

干预措施: Atropine Sulfate (Drug)

Research group

Experimental

The patients receiving Atropine and the extra Chinese herb formulas treatment

干预措施: Safflower (Carthamus Tinctorius) IgG4 | Serum | Allergy (Drug)

Research group

Experimental

The patients receiving Atropine and the extra Chinese herb formulas treatment

干预措施: Atropine Sulfate (Drug)

结局指标

主要结局

typical symptoms in patients with hypertensive bradyarrhythmia

时间窗: 2 weeks

The five indexes of typical symptoms in patients with hypertensive bradyarrhythmia (palpitation, angina, shortness of breath, dizzy, lumbar debility) were evaluated and scored both before treatment and after treatment according to "Guiding principles for clinical research of new Chinese Medicine".

次要结局

未报告次要终点

研究者

发起方
Jun Xiao
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Jun Xiao

Principal Investigator

Macrohard Institute of Health

研究点 (1)

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