A Phase 4 interventional study of Yangxin Shengmai and Yangxin Shengmai placebo in Coronary Heart Disease and Stable Angina, sponsored by Guang'anmen Hospital of China Academy of Chinese Medical Sciences. Status unknown. Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-11-13.
Sponsored by Guang'anmen Hospital of China Academy of Chinese Medical Sciences · Phase 4, Interventional, and Treatment
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.
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.
3,639 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.
This study's planned enrollment of 80 is below the median of 100 across 1,778 interventional studies indexed under Heart Diseases.
Browse Heart Diseases studies →Guang'anmen Hospital of China Academy of Chinese Medical Sciences is the lead sponsor of 133 studies on the registry; 36 are open to participants now.
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Exclusion Criteria:
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
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
Yangxin Shengmai Granules
Also known as: YXSM
Yangxin Shengmai placebo have an identical appearance and scent as the active treatment granules.
Also known as: YXSM placebo
Be used when angina attack
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%
Time frame: Four weeks after treatment
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.
Time frame: 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
Time frame: Two and four weeks after treatment
No study locations are listed for this record.
Plan to share: No
This study is status unknown, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
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Guang'anmen Hospital of China Academy of Chinese Medical Sciences