Coronary Heart DiseasePhase 4NCT04270071
Efficacy and Safety of Yangxin Shengmai Granules for the Treatment of Stable Angina Pectoris
A Phase 4 study testing Yangxin Shengmai and nitroglycerin tablets in people with Coronary Heart Disease and Stable Angina, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences.
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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Coronary Heart Disease, Stable Angina
- What is being tested?
- Yangxin Shengmai and nitroglycerin tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Dec 2020to Dec 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Efficacy and Safety of Yangxin Shengmai Granules for the Treatment of Stable Angina Pectoris: Randomised, Double Blind, Placebo Controlled Trial
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.
Read the 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.
- Conditions
- Coronary Heart Disease, Stable Angina
- Being tested
- Yangxin Shengmai, Yangxin Shengmai placebo, nitroglycerin tablets
- Keywords
- Yangxinshengmai granules, Stable angina pectoris, Coronary heart disease, Randomized controlled trial
- Medical subject headings
- Coronary Disease, Angina, Stable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yangxin ShengmaiDrug
Also called YXSM
Yangxin Shengmai Granules
Yangxin Shengmai placeboDrug
Also called YXSM placebo
Yangxin Shengmai placebo have an identical appearance and scent as the active treatment granules.
nitroglycerin tabletsDrug
Be used when angina attack
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Yangxin Shengmai placebo; Drug: nitroglycerin tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%
Measured: Four weeks after treatment
Secondary outcomes (2)
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.
Measured: Two and four weeks after treatment
Patient-reported outcomes in coronary heart disease
Through clinical outcome evaluation scale for patients with coronary heart disease with angina pectoris
Measured: Two and four weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study startDec 2020 (estimated)
- Primary completionOct 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun Li, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Investigators
- Jun Li, MD, Study director, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04270071
- Sponsor's protocol ID
- YXSM_2019001
- Status last verified
- Nov 2020
- First submitted
- 11 Feb 2020
- Last updated
- 13 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29686614Walters 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.
PubMed 29107310Kallistratos 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.
PubMed 31883335Chen 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.
PubMed 31860998Li 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.
PubMed 31829173Surveillance 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/
PubMed 31855330Yang 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.
PubMed 30918578Gong 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.
PubMed 28497986Li 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.
PubMed 25532378
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Yangxin Shengmai Granules for the Treatment of Stable Angina Pectoris: Randomised, Double Blind, Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT04270071
- Acronym / sponsor ID
- YXSM_2019001
- Conditions
- Coronary Heart Disease, Stable Angina
- Keywords
- Yangxinshengmai granules, Stable angina pectoris, Coronary heart disease, Randomized controlled trial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical SciencesUniversity, hospital or other
- Study start
- Dec 2020 (estimated)
- Primary completion
- Oct 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 17 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Yangxin Shengmai Granules | Experimental | Drug: Yangxin Shengmai, Drug: nitroglycerin tabletsPatients 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. |
| Placebo | Placebo comparator | Drug: Yangxin Shengmai placebo, Drug: nitroglycerin tabletsPatients 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. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yangxin ShengmaiAlso: YXSMYangxin Shengmai Granules | Drug | Yangxin Shengmai Granules |
| Yangxin Shengmai placeboAlso: YXSM placeboYangxin Shengmai placebo have an identical appearance and scent as the active treatment granules. | Drug | Placebo |
| nitroglycerin tabletsBe used when angina attack | Drug | Placebo, Yangxin Shengmai Granules |
Primary outcome
Stopping or reducing rate of the nitroglycerin tablets
Time frame: Four weeks after treatment
Number of nitroglycerin tablets used before medication - number of nitroglycerin tablets used after medication) / number of nitroglycerin tablets used before medication × 100%
2 secondary outcomes
Changes of angina symptom score
Time frame: Two and four weeks after treatment
Patient-reported outcomes in coronary heart disease
Time frame: Two and four weeks after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2020.
- Background: PubMed 29686614Liu 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 publication: PubMed 29107310Walters 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 publication: PubMed 31883335Kallistratos 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 publication: PubMed 31860998Chen 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 publication: PubMed 31829173Li 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 publication: PubMed 31855330Surveillance 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 publication: PubMed 30918578Yang 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.
- Results publication: PubMed 28497986Gong 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.
- Results publication: PubMed 25532378Li 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jun Li, MD study director
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Yangxin Shengmai and nitroglycerin tablets in people with Coronary Heart Disease and Stable Angina, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jun Li, MD (+86 13051458913, gamyylj@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stopping or reducing rate of the nitroglycerin tablets (time frame: Four weeks after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04270071, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2020.