Ignite Creation Date:
2025-12-25 @ 4:56 AM
Ignite Modification Date:
2026-03-03 @ 4:15 AM
Study NCT ID:
NCT02029118
Status:
COMPLETED
Last Update Posted:
2020-02-17
First Post:
2013-11-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acupoint Application in Patients With Stable Angina Pectoris (AASAP)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060050', 'term': 'Angina, Stable'}], 'ancestors': [{'id': 'D000787', 'term': 'Angina Pectoris'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002637', 'term': 'Chest Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000726774', 'term': 'storax'}, {'id': 'C022871', 'term': 'isoborneol'}, {'id': 'D065260', 'term': 'Frankincense'}, {'id': 'D024763', 'term': 'Leeching'}, {'id': 'D015669', 'term': 'Acupuncture Points'}, {'id': 'D001241', 'term': 'Aspirin'}], 'ancestors': [{'id': 'D012116', 'term': 'Resins, Plant'}, {'id': 'D001704', 'term': 'Biopolymers'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D053147', 'term': 'Plant Exudates'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D016740', 'term': 'Meridians'}, {'id': 'D015670', 'term': 'Acupuncture Therapy'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D012459', 'term': 'Salicylates'}, {'id': 'D062385', 'term': 'Hydroxybenzoates'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-13', 'studyFirstSubmitDate': '2013-11-24', 'studyFirstSubmitQcDate': '2014-01-06', 'lastUpdatePostDateStruct': {'date': '2020-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-01-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline Number of angina attacks at 12 weeks', 'timeFrame': 'at baseline,4, 8weeks after inclusion', 'description': 'The change frequency of angina attack during every 4-week.'}], 'secondaryOutcomes': [{'measure': 'Change from Baseline the severity of angina ( VAS score) at 12 weeks', 'timeFrame': 'at baseline,4, 8weeks after inclusion', 'description': 'The VAS score evaluation angina pain severity'}, {'measure': 'Change from Baseline the dosage of nitroglycerin at 12 weeks', 'timeFrame': 'at baseline,4, 8weeks after inclusion', 'description': 'Observed reduction in the dose of nitroglycerin'}, {'measure': 'Seattle Angina Questionnaire', 'timeFrame': 'at baseline,4, 8weeks after inclusion'}, {'measure': 'self-rating anxiety scale', 'timeFrame': 'at baseline,4, 8weeks after inclusion'}, {'measure': 'Self-rating Depression Scale', 'timeFrame': 'at baseline,4, 8weeks after inclusion'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Acupoint Application,Stable Angina Pectoris,herbal medicine'], 'conditions': ['Stable Angina Pectoris']}, 'referencesModule': {'references': [{'pmid': '34387828', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '25250055', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1.Meet the diagnostic criteria of American College of Cardiology(ACC)/American Heart Association (AHA) angina pectoris of coronary heart disease.\n\n2.35 ≤ age ≤ 85 years, both male and female.\n\n3.The onset of angina pectoris≥3 months, and the frequency of angina attack≥2 a week.\n\n4.Patients signed the informed consent\n\nExclusion Criteria:\n\n1. age≤35 or age≥85.\n2. Pregnant women or women in lactation or women of child bearing potential plan to conceive in the recent six months.\n3. history of diabetes.\n4. Co-infection or bleeding, allergic.\n5. Currently participating in other clinical trials'}, 'identificationModule': {'nctId': 'NCT02029118', 'acronym': 'AASAP', 'briefTitle': 'Acupoint Application in Patients With Stable Angina Pectoris (AASAP)', 'organization': {'class': 'OTHER', 'fullName': 'Chengdu University of Traditional Chinese Medicine'}, 'officialTitle': 'Effect of Acupoint Application With Herbal Medicine in Patients With Stable Angina Pectoris: Randomized, Controlled,Double Blind Clinical Study', 'orgStudyIdInfo': {'id': '2011SZ0302.2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Herbal application on acupoint group', 'description': 'Containing the herbal medicine application on the specific acupoints plus foundation treatment', 'interventionNames': ['Drug: Herbal plaster ( styrax, borneol, frankincense, santalum,trichosanthes kirilowii Maxim, allium macrostemon Bunge, leech)', 'Device: acupoint', 'Drug: Aspirin: 100mg qd; Metoprolol：25mg bid; Ramipril:5mg qd; Atorvastatin:20mg qn.']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo application on acupoint', 'description': 'Not containing herbal medicine application on the specific acupoints plus foundation treatment', 'interventionNames': ['Device: acupoint', 'Drug: Aspirin: 100mg qd; Metoprolol：25mg bid; Ramipril:5mg qd; Atorvastatin:20mg qn.']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Herbal application on non-acupoint group', 'description': 'Containing the herbal medicine application on the non-acupoints plus foundation treatment', 'interventionNames': ['Drug: Herbal plaster ( styrax, borneol, frankincense, santalum,trichosanthes kirilowii Maxim, allium macrostemon Bunge, leech)', 'Drug: Aspirin: 100mg qd; Metoprolol：25mg bid; Ramipril:5mg qd; Atorvastatin:20mg qn.']}, {'type': 'SHAM_COMPARATOR', 'label': 'Placebo application on non-acupoint', 'description': 'Not containing herbal medicine application on the non-acupoints plus foundation treatment', 'interventionNames': ['Drug: Aspirin: 100mg qd; Metoprolol：25mg bid; Ramipril:5mg qd; Atorvastatin:20mg qn.']}], 'interventions': [{'name': 'Herbal plaster ( styrax, borneol, frankincense, santalum,trichosanthes kirilowii Maxim, allium macrostemon Bunge, leech)', 'type': 'DRUG', 'otherNames': ['Herbal medicine application'], 'description': 'Application containing herbal medicine that mainly include styrax, borneol, frankincense, santalum,trichosanthes kirilowii Maxim, allium macrostemon Bunge, leech and other herbal medicine.', 'armGroupLabels': ['Herbal application on acupoint group', 'Herbal application on non-acupoint group']}, {'name': 'acupoint', 'type': 'DEVICE', 'otherNames': ['acupuncture point'], 'description': 'select acupoint according to traditional Chinese medicine', 'armGroupLabels': ['Herbal application on acupoint group', 'Placebo application on acupoint']}, {'name': 'Aspirin: 100mg qd; Metoprolol：25mg bid; Ramipril:5mg qd; Atorvastatin:20mg qn.', 'type': 'DRUG', 'otherNames': ['basic treatment'], 'description': 'foundation treatment', 'armGroupLabels': ['Herbal application on acupoint group', 'Herbal application on non-acupoint group', 'Placebo application on acupoint', 'Placebo application on non-acupoint']}]}, 'contactsLocationsModule': {'locations': [{'zip': '610072', 'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'facility': 'Affiliated hospital of Chengdu University of TCM', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}], 'overallOfficials': [{'name': 'Fanrong Liang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chengdu University of TCM'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chengdu University of Traditional Chinese Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}