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Danhong Injection for Chronic Stable Angina
NCT01681316Phase 4
Key facts
- Status
- Completed
- Start
- Dec 2012
- Primary completion
- Oct 2016
- Countries
- 1
- Sponsor
- China Academy of Chinese Medical Sciences
- Modality
- Botanical drug
- Drugs
- danhong injection
- Conditions
- angina pectoris
01
Overview
Phase 4, randomised, double-blind trial in angina pectoris comparing Danhong Injection with Placebo (2 arms). Primary endpoint: Angina-frequency score on the Seattle Angina Questionnaire at Day 30. Started Dec 2012; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Danhong Injection
Danhong injection + Standard medical care
Placebo
Placebo + Standard medical care
03
Who it enrols
Patients with chronic stable angina, CCS class II or III, and a diagnosis of 'Xueyu Zheng' (Blood Stasis Syndrome) with a score >= 15. Must have history of MI/ST-T changes, >50% stenosis, or confirmed CHD.
04
Endpoints
Primary
Angina-frequency score on the Seattle Angina Questionnaire
Secondary
Total score of symptoms questionnaire of TCM
Seattle Angina Questionnaire Physical Limitation Scale
Seattle Angina Questionnaire Angina Stability Scale
Seattle Angina Questionnaire Treatment Satisfaction Scale
Seattle Angina Questionnaire Quality of Life Scale
Frequency of anginal attack every week
Canadian Cardiovascular Society (CCS) grading of angina pectoris
Consumption of Short-acting Nitrates
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