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

Primary Purpose

Coronary Heart Disease, Stable Angina

Status

Unknown status

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Yangxin Shengmai

Yangxin Shengmai placebo

nitroglycerin tablets

About this trial

This is an interventional treatment trial for Coronary Heart Disease focused on measuring Yangxinshengmai granules, Stable angina pectoris, Coronary heart disease, Randomized controlled trial

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Yangxin Shengmai Granules

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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%

Secondary Outcome Measures

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.

Patient-reported outcomes in coronary heart disease

Through clinical outcome evaluation scale for patients with coronary heart disease with angina pectoris

Full Information

NCT ID

NCT04270071

First Posted

February 11, 2020

Last Updated

November 11, 2020

Sponsor

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

1. Study Identification

Unique Protocol Identification Number

NCT04270071

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Unknown status

Study Start Date

December 2020 (Anticipated)

Primary Completion Date

October 2021 (Anticipated)

Study Completion Date

December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

5. Study Description

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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Heart Disease, Stable Angina

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Yangxin Shengmai Granules

Arm Type

Experimental

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Yangxin Shengmai

Other Intervention Name(s)

YXSM

Intervention Description

Yangxin Shengmai Granules

Intervention Type

Drug

Intervention Name(s)

Yangxin Shengmai placebo

Other Intervention Name(s)

YXSM placebo

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

nitroglycerin tablets

Intervention Description

Be used when angina attack

Primary Outcome Measure Information:

Title

Stopping or reducing rate of the nitroglycerin tablets

Description

Number of nitroglycerin tablets used before medication - number of nitroglycerin tablets used after medication) / number of nitroglycerin tablets used before medication × 100%

Time Frame

Four weeks after treatment

Secondary Outcome Measure Information:

Title

Changes of angina symptom score

Description

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.

Time Frame

Two and four weeks after treatment

Title

Patient-reported outcomes in coronary heart disease

Description

Through clinical outcome evaluation scale for patients with coronary heart disease with angina pectoris

Time Frame

Two and four weeks after treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jun Li, MD

Phone

+86 13051458913

gamyylj@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jun Li, MD

Organizational Affiliation

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Official's Role

Study Director

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

29686614

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.

Results Reference

background

PubMed Identifier

29107310

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.

Results Reference

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PubMed Identifier

31883335

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

Results Reference

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PubMed Identifier

31860998

Citation

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.

Results Reference

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PubMed Identifier

31829173

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, 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.

Results Reference

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PubMed Identifier

31855330

Citation

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/

Results Reference

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PubMed Identifier

30918578

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 2019.

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PubMed Identifier

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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.

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PubMed Identifier

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Citation

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Results Reference

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

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