drugset / Trial / NCT04661709
Efficacy and Safety of Wen Xin Granules for the Treatment of Unstable Angina Pectoris
Phase 4
Unknown
502 enrolled
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
National Natural Science Foundation of China · collabSpecial Project of National Traditional Chinese Medicine Clinical Research Base of State Administration of Traditional Chinese Medicine · collab
RandomizedParallel-groupTriple-blindTreatment
Summary
This is a double-blind, randomized placebo-controlled trial which aims to evaluate the efficacy and safety of Wen Xin granule in patients with unstable angina pectoris.
Timeline
- Start
- 2021-03-01
- Primary completion
- 2023-03-01
- Completion
- 2023-06-01
Publications
- Background Niccoli G, Montone RA, Lanza GA, Crea F. Angina after percutaneous coronary intervention: The need for precision medicine. Int J Cardiol. 2017 Dec 1;248:14-19. doi: 10.1016/j.ijcard.2017.07.105. Epub 2017 Aug 12.
- Background Ambrose JA, Dangas G. Unstable angina: current concepts of pathogenesis and treatment. Arch Intern Med. 2000 Jan 10;160(1):25-37. doi: 10.1001/archinte.160.1.25.
- Background Smith JN, Negrelli JM, Manek MB, Hawes EM, Viera AJ. Diagnosis and management of acute coronary syndrome: an evidence-based update. J Am Board Fam Med. 2015 Mar-Apr;28(2):283-93. doi: 10.3122/jabfm.2015.02.140189.
- Results Jiang M, Zhang C, Zheng G, Guo H, Li L, Yang J, Lu C, Jia W, Lu A. Traditional chinese medicine zheng in the era of evidence-based medicine: a literature analysis. Evid Based Complement Alternat Med. 2012;2012:409568. doi: 10.1155/2012/409568. Epub 2012 Jun 6.
- Results Zhang HJ, Wang ZX. Yin-yang and Zheng: Exported from Chinese medicine. Chin J Integr Med. 2014 Apr;20(4):250-5. doi: 10.1007/s11655-014-1777-z. Epub 2014 Apr 3.
- Tian PP, Wu QJ, Li J, Chen HW, Wu J, Deng YW, Xie ZC, Zhao W, Tan YQ. Efficacy and safety of Chinese herbal medicine Wen Xin granules for the treatment of unstable angina pectoris with Yang deficiency and blood stasis syndrome: study protocol for a randomized controlled trial. Trials. 2021 Nov 13;22(1):798. doi: 10.1186/s13063-021-05771-y.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Wen Xin granule | Unknown | — | Oral |
| Background | Aspirin | Small molecule | 100 mg | Oral |
| Background | Atorvastatin | Small molecule | 20 mg | Oral |
| Background | Clopidogrel | Small molecule | 75 mg | Oral |
| Background | Isosorbide Mononitrate | Other / unclassified | 20 mg | Oral |
| Background | Metoprolol | Other / unclassified | 12.5 mg | Oral |
| Background | Metoprolol | Other / unclassified | 25 mg | Oral |
| Background | Nitroglycerin | Unknown | — | — |
| Background | Trimetazidine | Small molecule | 20 mg | Oral |