Stable Angina Pectoris
Conditions
Keywords
Acupoint Application,Stable Angina Pectoris,herbal medicine
Brief summary
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.
Detailed description
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.
Interventions
DRUGHerbal plaster ( styrax, borneol, frankincense, santalum,trichosanthes kirilowii Maxim, allium macrostemon Bunge, leech)
Application containing herbal medicine that mainly include styrax, borneol, frankincense, santalum,trichosanthes kirilowii Maxim, allium macrostemon Bunge, leech and other herbal medicine.
DEVICEacupoint
select acupoint according to traditional Chinese medicine
DRUGAspirin: 100mg qd; Metoprolol：25mg bid; Ramipril:5mg qd; Atorvastatin:20mg qn.
foundation treatment
Sponsors
Chengdu University of Traditional Chinese Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
35 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
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
Exclusion criteria
1. age≤35 or age≥85. 2. Pregnant women or women in lactation or women of child bearing potential plan to conceive in the recent six months. 3. history of diabetes. 4. Co-infection or bleeding, allergic. 5. Currently participating in other clinical trials
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline Number of angina attacks at 12 weeks | at baseline,4, 8weeks after inclusion | The change frequency of angina attack during every 4-week. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline the severity of angina ( VAS score) at 12 weeks | at baseline,4, 8weeks after inclusion | The VAS score evaluation angina pain severity |
| Change from Baseline the dosage of nitroglycerin at 12 weeks | at baseline,4, 8weeks after inclusion | Observed reduction in the dose of nitroglycerin |
| Seattle Angina Questionnaire | at baseline,4, 8weeks after inclusion | — |
| self-rating anxiety scale | at baseline,4, 8weeks after inclusion | — |
| Self-rating Depression Scale | at baseline,4, 8weeks after inclusion | — |
Countries
China
Outcome results
None listed