Key result
Danlou tablet RCT protocol evaluates effects on angina frequency in stable angina pectoris.
Why the study?
Danlou tablet is widely used for angina pectoris in China, but previous trials evaluating its efficacy had inadequate methodologies.
Does Danlou tablet reduce angina frequency per week in adults with stable angina?
RCT (n=76)
Double-blind
1:1
Does Danlou tablet reduce angina frequency per week in adults with stable angina?
This study protocol outlines a randomized controlled trial to evaluate the efficacy and safety of the traditional Chinese medicine Danlou tablet for stable angina pectoris.
Danlou tablets added to Western medicine may reduce angina frequency in SAP with IPBS; extends RCT evidence for TCM adjuncts.
INTRODUCTION: Stable angina pectoris has a high prevalence and causes serious harm. Revascularization therapy can relieve angina pectoris to some extent, but it is not widely accepted in China due to the cost and secondary events. The Chinese proprietary medicine Danlou tablet has been widely used to treat angina pectoris, but previous trials had inadequate methodologies. In this study, we aim to conduct a randomized controlled trial to evaluate its efficacy and safety on stable angina. METHODS AND ANALYSIS: This study is a WeChat-based randomized, double-blind, and placebo-controlled clinical trial in China. Eligible participants are adults (aged 30-75 years) with CT-confirmed stable angina and traditional Chinese medicine-diagnosed intermingled phlegm and blood stasis syndrome. A total of 76 participants will be randomly allocated in a 1:1 ratio to the oral Danlou tablet group (1.5 mg a time, 3 times daily for 28 days) or the placebo group. Patients are permitted concomitant use of routine medications during these 28 days. The primary outcome is angina frequency per week. The secondary outcomes include angina severity, angina duration, traditional Chinese medicine efficacy, the withdrawal rate of emergency medications, blood lipids, and electrocardiograph efficacy. The WeChat app will be used to remind patients to take their medicines and fill out the forms. All data will be recorded in case report forms and analyzed by Statistical Analysis System software. ETHICS AND DISSEMINATION: This study has been approved by the Ethics Committee of Guang'anmen Hospital, China Academy of Chinese Medical Sciences in Beijing, China (No. 2019-225-KY). TRIAL REGISTRATION NUMBER: ClinicalTrials.gov, ID: ChiCTR1900028068.
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He et al. (2020) conducted an RCT in stable angina pectoris (n=76). Danlou tablet vs. placebo was evaluated on angina frequency per week. This protocol describes a randomized, double-blind, placebo-controlled trial of 76 patients to evaluate the efficacy of Danlou tablet on angina frequency in stable angina pectoris.
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