Efficacy and Safety of Yangxin Shengmai Granules for the Treatment of Stable Angina Pectoris

Coronary Heart Disease Clinical Trial

Official title:

Efficacy and Safety of Yangxin Shengmai Granules for the Treatment of Stable Angina Pectoris: Randomised, Double Blind, Placebo Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04270071
• Other study ID #: YXSM_2019001
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: December 2020
• Est. completion date: December 2021

Study information

• Verified date: November 2020
• Source: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Contact: Jun Li, MD
• Phone: +86 13051458913
• Email: gamyylj[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is a randomized, double-blind, placebo-controlled, parallel clinical trial in Chinese population with stable angina pectoris. The purpose is to determine the efficacy and safety of Yangxin Shengmai Granules in the treatment of stable angina pectoris.

Description:

Yangxin Shengmai granules is a Chinese patent medicine composed of ginseng, Ophiopogon japonicus, Salvia miltiorrhiza, Schisandra chinensis, etc. It is used for the treatment of chest pain caused by Qi-yin deficiency and blood stasis in traditional Chinese medicine. The symptoms include chest tightness, chest pain, palpitation, shortness of breath, fatigue, dry mouth and dry throat. Clinical applications suggested that Yangxin Shengmai granules were safe and effective in the treatment of coronary heart disease. However, high-quality clinical trials are still needed to further confirm, so as to provide theoretical basis for the treatment of stable angina pectoris with traditional Chinese medicine.

The study is designed to determine the efficacy and safety of Yangxin Shengmai Granules in the treatment of stable angina pectoris.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: December 2021
• Est. primary completion date: October 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

Inclusion Criteria:

• Participants are aged between 40 and 75 years.

• Meet the diagnostic criteria of stable angina pectoris.

• Meet Chinese medicine syndrome differentiation of Qi-yin deficiency and blood stasis syndrome.

• Voluntarily participate and sign informed consent.

Exclusion Criteria:

• Patients were diagnosed as acute myocardial infarction, unstable angina, stable exertion angina and other heart diseases.

• Patients with poor control of hypertension and diabetes, severe cardiopulmonary insufficiency, severe arrhythmia (rapid atrial fibrillation, atrial flutter, paroxysmal ventricular tachycardia, etc.), with a history of heart pacemaker or cerebrovascular disease within one year.

• Any of the following disease history or evidence was found in the screening period:

severe cardiovascular or cerebrovascular diseases; active, recurrent peptic ulcer or other bleeding risk diseases; other serious diseases of digestive system; combined with malignant tumor, blood system disease, serious or progressive diseases of the other system; combined with mental diseases.

• Before screening, any laboratory inspection index meets the following standards: The results showed that Glutamic aspartate transaminase (AST) or alanine aminotransferase (ALT) were more than 1.5 times of the upper limit of normal value and serum creatinine (Cr) was more than 1.2 times of the upper limit of normal value.

• With a history of alcohol and drug abuse.

• Pregnant or lactating women.

• Patients who have participated in clinical trials of other drugs within 3 months before enrollment.

Related Conditions & MeSH terms

• Angina Pectoris
• Angina, Stable
• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Myocardial Ischemia
• Stable Angina

Intervention

Drug:
• Yangxin Shengmai
Yangxin Shengmai Granules
• Yangxin Shengmai placebo
Yangxin Shengmai placebo have an identical appearance and scent as the active treatment granules.
• nitroglycerin tablets
Be used when angina attack

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Guang'anmen Hospital of China Academy of Chinese Medical Sciences

References & Publications (9)

Chen M, Men L, Wu H, Zhong G, Ou L, Li T, Guo Y, Lin H, Zhang J, Wang D, Zhang Z. A systematic review of the effectiveness and safety of Chinese herbal medicine formula Gualou Xiebai Banxia (GLXBBX) decoction for the treatment of stable angina pectoris. M — View Citation

Gong P, Li Y, Yao C, Guo H, Hwang H, Liu X, Xu Y, Wang X. Traditional Chinese Medicine on the Treatment of Coronary Heart Disease in Recent 20 Years. J Altern Complement Med. 2017 Sep;23(9):659-666. doi: 10.1089/acm.2016.0420. Epub 2017 May 12. Review. — View Citation

Kallistratos MS, Poulimenos LE, Manolis AJ. Beta blockers, calcium channel blockers, and long-acting nitrates for patients with stable angina and low blood pressure levels: should this recommendation be reconsidered? Eur Heart J. 2020 Jan 14;41(3):479. do — View Citation

Li GH, Jiang HY, Xie YM, Jiang JJ, Yang W, Zhao W, Zhuang Y, Wang YY. [Analysis of traditional Chinese medicine syndrome, traditional Chinese medicine and western medicine in 84 697 patients with coronary heart disease based on big data]. Zhongguo Zhong Y — View Citation

Li Y, Zhang L, Lv S, Wang X, Zhang J, Tian X, Zhang Y, Chen B, Liu D, Yang J, Dong P, Xu Y, Song Y, Shi J, Li L, Wang X, Han Y. Efficacy and safety of oral Guanxinshutong capsules in patients with stable angina pectoris in China: a prospective, multicente — View Citation

Liu S, Tian G, Chen J, Zhang X, Wu A, Li M, Sun Y, Liu B, Xing Y, Shang H. Traditional Chinese Medicine for Bradyarrhythmia: Evidence and Potential Mechanisms. Front Pharmacol. 2018 Apr 9;9:324. doi: 10.3389/fphar.2018.00324. eCollection 2018. — View Citation

Surveillance report 2016 - Stable angina: management (2011) NICE guideline CG126 [Internet]. London: National Institute for Health and Care Excellence (UK); 2016 Apr 3. No abstract available. Available from http://www.ncbi.nlm.nih.gov/books/NBK551066/ — View Citation

Walters MA. Management of Chronic Stable Angina. Crit Care Nurs Clin North Am. 2017 Dec;29(4):487-493. doi: 10.1016/j.cnc.2017.08.008. Epub 2017 Sep 29. Review. — View Citation

Yang X, He T, Han S, Zhang X, Sun Y, Xing Y, Shang H. The Role of Traditional Chinese Medicine in the Regulation of Oxidative Stress in Treating Coronary Heart Disease. Oxid Med Cell Longev. 2019 Feb 24;2019:3231424. doi: 10.1155/2019/3231424. eCollection — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stopping or reducing rate of the nitroglycerin tablets	Number of nitroglycerin tablets used before medication - number of nitroglycerin tablets used after medication) / number of nitroglycerin tablets used before medication × 100%	Four weeks after treatment
Secondary	Changes of angina symptom score	The angina symptom score regroups three items: degree of the frequency, duration and severity of angina attacks. The score of each item is 0,2,4,6. And higher scores mean a worse outcome.	Two and four weeks after treatment
Secondary	Patient-reported outcomes in coronary heart disease	Through clinical outcome evaluation scale for patients with coronary heart disease with angina pectoris	Two and four weeks after treatment