Danhong Injection in the Treatment of Chronic Stable Angina
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ClinicalTrials.gov Identifier: NCT01681316 |
Recruitment Status
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Completed
First Posted
: September 7, 2012
Last Update Posted
: October 12, 2016
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Sponsor:
China Academy of Chinese Medical Sciences
Collaborator:
China Food and Drug Administration
Information provided by (Responsible Party):
Zhong Wang, China Academy of Chinese Medical Sciences
Tracking Information | |||||||||||||
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First Submitted Date ICMJE | September 5, 2012 | ||||||||||||
First Posted Date ICMJE | September 7, 2012 | ||||||||||||
Last Update Posted Date | October 12, 2016 | ||||||||||||
Study Start Date ICMJE | December 2012 | ||||||||||||
Actual Primary Completion Date | October 2016 (Final data collection date for primary outcome measure) | ||||||||||||
Current Primary Outcome Measures ICMJE |
The proportion of patients in each treatment group who had clinically significant change as defined by the angina-frequency score on the Seattle Angina Questionnaire at day 30 [ Time Frame: Day 30 ] Seattle Angina Questionnaire, a 19-item questionnaire that quantifies physical limitations due to angina, any recent change in the severity of angina, the frequency of angina, satisfaction with treatment, and quality of life. Scores range from 0 to 100; higher scores indicate better health status.With a score of 20 or more on the angina-frequency scale indicating that the patient was clinically significant change.
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||
Change History | Complete list of historical versions of study NCT01681316 on ClinicalTrials.gov Archive Site | ||||||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||
Current Other Outcome Measures ICMJE |
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Original Other Outcome Measures ICMJE |
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Descriptive Information | |||||||||||||
Brief Title ICMJE | Danhong Injection in the Treatment of Chronic Stable Angina | ||||||||||||
Official Title ICMJE | A Randomized, Multi-center, Double-blind, Placebo-controlled Trial of Danhong Injection in the Treatment of Chronic Stable Angina | ||||||||||||
Brief Summary | The purpose of this study is to evaluate the effect of Danhong Injection on the relief of angina with the use of the Seattle Angina Questionnaire among patients with stable angina patients | ||||||||||||
Detailed Description | Not Provided | ||||||||||||
Study Type ICMJE | Interventional | ||||||||||||
Study Phase | Phase 4 | ||||||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Chronic Stable Angina | ||||||||||||
Intervention ICMJE |
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Study Arms |
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Publications * | Wang PQ, Li DD, Dong W, Liu J, Yu YN, Shen CT, Chen QG, Chen BW, Chen YD, Wang Z. Danhong injection in the treatment of chronic stable angina: study protocol for a randomized controlled trial. Trials. 2015 Oct 21;16:474. doi: 10.1186/s13063-015-0998-1. | ||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||
Recruitment Status ICMJE | Completed | ||||||||||||
Actual Enrollment ICMJE |
920 | ||||||||||||
Original Estimated Enrollment ICMJE |
870 | ||||||||||||
Actual Study Completion Date | October 2016 | ||||||||||||
Actual Primary Completion Date | October 2016 (Final data collection date for primary outcome measure) | ||||||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years to 70 Years (Adult, Senior) | ||||||||||||
Accepts Healthy Volunteers | No | ||||||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||
Listed Location Countries ICMJE | China | ||||||||||||
Removed Location Countries | |||||||||||||
Administrative Information | |||||||||||||
NCT Number ICMJE | NCT01681316 | ||||||||||||
Other Study ID Numbers ICMJE | DH20120703 | ||||||||||||
Has Data Monitoring Committee | Yes | ||||||||||||
U.S. FDA-regulated Product | Not Provided | ||||||||||||
IPD Sharing Statement | Not Provided | ||||||||||||
Responsible Party | Zhong Wang, China Academy of Chinese Medical Sciences | ||||||||||||
Study Sponsor ICMJE | China Academy of Chinese Medical Sciences | ||||||||||||
Collaborators ICMJE | China Food and Drug Administration | ||||||||||||
Investigators ICMJE |
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PRS Account | China Academy of Chinese Medical Sciences | ||||||||||||
Verification Date | October 2016 | ||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |