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Efficacy and safety of Naoxintong capsule for treating chronic stable angina: study protocol for a randomized
Gao Huanjia1, Cai Hairong1, Zhuang Jieqin2
1The Second Clinical College of Guangzhou University of Chinese Medicine, Guangzhou, 510405, Guangdong Province, China.
Insights
This study evaluates the efficacy and safety of Naoxintong (NXT) capsule for chronic stable angina (CSA). Results will provide clinical evidence for this traditional Chinese medicine in treating CSA.
Area of Science:
- Cardiology
- Traditional Chinese Medicine
- Clinical Trials
Background:
- Cardiovascular disease, particularly chronic stable angina (CSA), poses a significant global health burden.
- Naoxintong (NXT) capsule is a traditional Chinese medicine used for CSA, but robust clinical evidence is limited.
- This study aims to address the evidence gap regarding NXT capsule's utility in CSA management.
Purpose of the Study:
- To evaluate the therapeutic efficacy of Naoxintong (NXT) capsule compared to placebo in patients with chronic stable angina (CSA).
- To assess the safety profile and adverse events associated with NXT capsule treatment.
Main Methods:
- A multicenter, randomized, double-blind, placebo-controlled trial involving 260 participants.
- Participants received either NXT capsule or placebo for 12 weeks after a 2-week run-in period.
- Primary outcome: therapeutic efficacy; Secondary outcomes: TCM syndrome scores, angina severity, nitroglycerin use, Seattle Angina Scale scores, homocysteine levels, and cardiovascular events.
Main Results:
- Primary outcome is therapeutic efficacy.
- Secondary outcome measures include TCM syndrome scores, angina severity, nitroglycerin dosage, Seattle Angina Scale scores, serum homocysteine, and cardiovascular event incidence.
- Safety and adverse events will be monitored throughout the trial.
Conclusions:
- The study is designed according to CFDA guidelines.
- Results are expected to provide robust clinical evidence on the efficacy and safety of NXT capsule for CSA treatment.
- This research will inform the clinical application of Naoxintong in managing chronic stable angina.
Background:
Cardiovascular disease is the leading cause of mortality and morbidity worldwide, Chronic stable angina (CSA) is the main symptom of myocardial ischemia, causes increased risk of major cardiovascular events such as sudden cardiac death and myocardial infarction. Naoxintong (NXT) capsule is a classical traditional Chinese medication used to treat CSA, however, few evidence to support the wide utility of NXT capsule for the treatment of CSA. We design this study to evaluate the efficacy and safety of NXT capsule versus placebo in patients with CSA.
Methods/Design:
This is a multicenter, randomized, double-blind, placebo-controlled clinical trial. A total of 260 eligible participants will be enrolled. The participants will be randomized assigned in an equal ratio to groups receiving either NXT or placebo for 12 weeks. After a 2-week run-in period, they will receive either NXT or placebo (3 pills, 3 times daily) for 12 weeks. The primary outcome is therapeutic efficacy. Secondary outcome measures include the quantitative score of TCM syndromes, severity grading of angina pectoris, the number of angina pectoris per week, nitroglycerin dosage, score of Seattle angina scale, serum homocysteine, and incidence of cardiovascular events. Safety outcomes and adverse events will be monitored throughout the trial.
Discussion:
We designed this study in accordance with principles and regulations issued by the China Food and Drug Administration (CFDA). The results will provide clinical evidence of the efficacy and safety of NXT Capsule in the treatment of CSA.
Trial Registration:
Chinese Clinical Trial Registry ChiCTR2100044563 . Registered on 24 March 2020.
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