Effect of Acupoint Application With Herbal Medicine in Patients With Stable Angina Pectoris: Randomized, Controlled,Double Blind Clinical Study
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Change from Baseline Number of angina attacks at 12 weeks
研究概览
简要总结
Hypothesis: acupoint application is effective for managing chronic stable angina pectoris. Aim: to evaluate the efficacy and safety of acupoint application on the specific acupoints for chronic stable angina pectoris. Design: A Randomized, Controlled,Double Blind trial. 200 participants will be included. Four arms: herbal medicine application on acupoint group , placebo application on acupoint group , herbal medicine application on non-acupoint group and placebo application on non-acupoint group.
详细描述
Acupoint application with herbal medicine is a kind of external treatment of traditional Chinese medicine and has a long history in China, which is use herbal medicine made of plaster and stick to specific acupoints, using the double effects of acupoints and herb to treat disease. In China, acupoint application with herbal medicine has been used in clinical treatment of angina pectoris, but there is no convincing evidence for the efficacy of acupoint application for angina pectoris, due to low methodologic quality and small sample size. The investigators designed the Randomized, Controlled, Double Blind clinical trial to investigates the efficacy of acupoint application in treating angina pectoris, the purpose of this study is to provide the convincing evidence for acupoint application treatment of angina pectoris.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.Meet the diagnostic criteria of American College of Cardiology(ACC)/American Heart Association (AHA) angina pectoris of coronary heart disease.
- •2.35 ≤ age ≤ 85 years, both male and female.
- •3.The onset of angina pectoris≥3 months, and the frequency of angina attack≥2 a week.
- •4.Patients signed the informed consent
排除标准
- •age≤35 or age≥
- •Pregnant women or women in lactation or women of child bearing potential plan to conceive in the recent six months.
- •history of diabetes.
- •Co-infection or bleeding, allergic.
- •Currently participating in other clinical trials
研究组 & 干预措施
Herbal application on acupoint group
Containing the herbal medicine application on the specific acupoints plus foundation treatment
干预措施: Herbal plaster ( styrax, borneol, frankincense, santalum,trichosanthes kirilowii Maxim, allium macrostemon Bunge, leech) (Drug)
Herbal application on acupoint group
Containing the herbal medicine application on the specific acupoints plus foundation treatment
干预措施: acupoint (Device)
Placebo application on acupoint
Not containing herbal medicine application on the specific acupoints plus foundation treatment
干预措施: acupoint (Device)
Herbal application on non-acupoint group
Containing the herbal medicine application on the non-acupoints plus foundation treatment
干预措施: Herbal plaster ( styrax, borneol, frankincense, santalum,trichosanthes kirilowii Maxim, allium macrostemon Bunge, leech) (Drug)
结局指标
主要结局
Change from Baseline Number of angina attacks at 12 weeks
时间窗: at baseline,4, 8weeks after inclusion
The change frequency of angina attack during every 4-week.
次要结局
- Self-rating Depression Scale(at baseline,4, 8weeks after inclusion)
- Change from Baseline the severity of angina ( VAS score) at 12 weeks(at baseline,4, 8weeks after inclusion)
- Change from Baseline the dosage of nitroglycerin at 12 weeks(at baseline,4, 8weeks after inclusion)
- self-rating anxiety scale(at baseline,4, 8weeks after inclusion)
- Seattle Angina Questionnaire(at baseline,4, 8weeks after inclusion)