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

NCT04270071 | Unknown Phase 4

• 1 other identifier: YXSM_2019001
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Coronary Heart Disease; Stable Angina

Keywords

Yangxinshengmai granules; Stable angina pectoris; Coronary heart disease; Randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Changes of angina symptom score

  Two and four weeks after treatment

• Patient-reported outcomes in coronary heart disease

  Two and four weeks after treatment

Study Arms (2)

Yangxin Shengmai Granules

EXPERIMENTAL

Patients were given Yangxin Shengmai granules orally 14g (1 bag) each time, 3 times daily for 4 weeks. And nitroglycerin tablets are used when angina attack. For patients who have used drugs such as aspirin, angiotensin-converting enzyme inhibitor, lipid-lowering drugs to treat coronary heart disease before inclusion, they can continue to use the original varieties and doses, without dose adjustment.

Drug: Yangxin Shengmai; Drug: nitroglycerin tablets

Placebo

PLACEBO COMPARATOR

Patients were given Yangxin Shengmai granules simulation orally 14g (1 bag) each time, 3 times daily for 4 weeks. And nitroglycerin tablets are used when angina attack. For patients who have used drugs such as aspirin, angiotensin-converting enzyme inhibitor, lipid-lowering drugs to treat coronary heart disease before inclusion, they can continue to use the original varieties and doses, without dose adjustment.

Drug: Yangxin Shengmai placebo; Drug: nitroglycerin tablets

Interventions

Yangxin Shengmai DRUG

Yangxin Shengmai Granules

Also known as: YXSM

Yangxin Shengmai Granules

Yangxin Shengmai placebo DRUG

Yangxin Shengmai placebo have an identical appearance and scent as the active treatment granules.

Also known as: YXSM placebo

Placebo

nitroglycerin tablets DRUG

Be used when angina attack

Placebo; Yangxin Shengmai Granules

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guang'anmen Hospital of China Academy of Chinese Medical Sciences: lead

Related Publications (9)

• 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.

  PMID: 29686614 BACKGROUND

• 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.

  PMID: 29107310 RESULT

• 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. doi: 10.1093/eurheartj/ehz900. No abstract available.

  PMID: 31883335 RESULT

• 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. Medicine (Baltimore). 2019 Dec;98(51):e18375. doi: 10.1097/MD.0000000000018375.

  PMID: 31860998 RESULT

• 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, multicenter, double-blind, placebo-controlled, randomized clinical trial. BMC Complement Altern Med. 2019 Dec 11;19(1):363. doi: 10.1186/s12906-019-2778-z.

  PMID: 31829173 RESULT

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

  PMID: 31855330 RESULT

• 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 2019.

  PMID: 30918578 RESULT

• 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.

  PMID: 28497986 RESULT

• 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 Yao Za Zhi. 2014 Sep;39(18):3462-8. Chinese.

  PMID: 25532378 RESULT

MeSH Terms

Conditions

Coronary Disease; Angina, Stable

Interventions

Nitroglycerin

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Angina Pectoris; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nitro Compounds; Organic Chemicals

Study Officials

• Jun Li, MD

  Guang'anmen Hospital of China Academy of Chinese Medical Sciences

  STUDY DIRECTOR

Central Study Contacts

Jun Li, MD

CONTACT

+86 13051458913; gamyylj@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: February 11, 2020
• First Posted: February 17, 2020
• Study Start: December 1, 2020
• Primary Completion: October 1, 2021
• Study Completion: December 1, 2021
• Last Updated: November 13, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share