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Efficacy and Safety Study of Guanxin Shutong Capsule to Treat Chronic Stable Angina: A Randomised, Double-blind, Placebo-controlled Clinical Trial
Compared with placebo, assess of the efficacy and safety of Guanxin Shutong capsule to treat chronic stable angina (syndrome of blood stasis resistance), and the result will be used for the basis of later Ⅳ clinical trial.
Details
| Lead sponsor | Shaanxi Buchang Pharmaceutical Co., Ltd |
|---|---|
| Phase | Phase 4 |
| Status | UNKNOWN |
| Enrolment | 300 |
| Start date | 2014-10 |
| Completion | 2015-10 |
Conditions
- Angina, Stable
Interventions
- Guanxin Shutong Capsule
- Placebo Capsule
- nitroglycerine
Primary outcomes
- Therapeutic effect to Angina ( Average value of angina frequency) — 6 weeks
Record angina frequency per week. Record date is Start-up Stage 1st week, Start-up Stage 2st week, Interview Stage 1st week, Interview Stage 2st week, Interview Stage 3st week and Interview Stage 4st week (Toal of 6 times). - Exercise treadmill testing (ETT) — 4 weeks
ST-segment displacement in electrocardiogram: Observe ST-segment displacement of J point after 60ms, including the degree of ST-segment depression.
Countries
China