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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Herbal application on acupoint group | Experimental | Containing the herbal medicine application on the specific acupoints plus foundation treatment |
|
| Placebo application on acupoint | Placebo Comparator | Not containing herbal medicine application on the specific acupoints plus foundation treatment |
|
| Herbal application on non-acupoint group | Placebo Comparator | Containing the herbal medicine application on the non-acupoints plus foundation treatment |
|
| Placebo application on non-acupoint | Sham Comparator | Not containing herbal medicine application on the non-acupoints plus foundation treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Herbal plaster ( styrax, borneol, frankincense, santalum,trichosanthes kirilowii Maxim, allium macrostemon Bunge, leech) | Drug | Application containing herbal medicine that mainly include styrax, borneol, frankincense, santalum,trichosanthes kirilowii Maxim, allium macrostemon Bunge, leech and other herbal medicine. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline Number of angina attacks at 12 weeks | The change frequency of angina attack during every 4-week. | at baseline,4, 8weeks after inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline the severity of angina ( VAS score) at 12 weeks | The VAS score evaluation angina pain severity | at baseline,4, 8weeks after inclusion |
| Change from Baseline the dosage of nitroglycerin at 12 weeks |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Fanrong Liang | Chengdu University of TCM | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Affiliated hospital of Chengdu University of TCM | Chengdu | Sichuan | 610072 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34387828 | Derived | Li DH, Xie J, Ren YL, Zheng H, Lyu JL, Leng JY, Zhang LL, Zhang J, Fan HL, Liang FR. Effectiveness and Safety of Acupoint Application of Guan Xin Su He Pill () for Patients with Chronic Stable Angina Pectoris: A Multi-Center, Randomized Controlled Trial. Chin J Integr Med. 2021 Nov;27(11):838-845. doi: 10.1007/s11655-021-2870-3. Epub 2021 Aug 13. | |
| 25250055 |
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|
|
| acupoint | Device | select acupoint according to traditional Chinese medicine |
|
|
| Aspirin: 100mg qd; Metoprolol：25mg bid; Ramipril:5mg qd; Atorvastatin:20mg qn. | Drug | foundation treatment |
|
|
Observed reduction in the dose of nitroglycerin
| at baseline,4, 8weeks after inclusion |
| 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 |
| Ren Y, Li D, Zheng H, Lv J, Leng J, Zhang L, Zhang J, Fan H, Liang F. Acupoint application in patients with chronic stable angina pectoris: study protocol of a randomized, double-blind, controlled trial. Evid Based Complement Alternat Med. 2014;2014:619706. doi: 10.1155/2014/619706. Epub 2014 Aug 27. |
| ID | Term |
|---|---|
| D060050 | Angina, Stable |
| ID | Term |
|---|---|
| D000787 | Angina Pectoris |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000726774 | storax |
| C022871 | isoborneol |
| D065260 | Frankincense |
| D024763 | Leeching |
| D015669 | Acupuncture Points |
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D012116 | Resins, Plant |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D053147 | Plant Exudates |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D013812 | Therapeutics |
| D016740 | Meridians |
| D015670 | Acupuncture Therapy |
| D000529 | Complementary Therapies |
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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