BACKGROUND: @entity5749 is a leading cause of @entity204 worldwide. Danhong injection, a complementary alternative medicine for @entity5749 , has been demonstrated to be effective in numerous studies and is widely prescribed to @entity1 . However, the methodological quality of most prior studies was found to be, in general, low. Therefore, we designed this randomized controlled trial to evaluate the efficacy and safety of using Danhong injection to treat @entity5749 . METHODS/DESIGN: This is a randomized multicentre, double-blind, placebo-controlled, adaptive clinical trial. A total of 870 @entity1 meeting the eligibility criteria will be randomly assigned into either the Danhong injection or the placebo group in a 2:1 ratio. @entity1 will then undergo a 2-week treatment regimen and a 76-day follow-up period. Because this is an adaptive trial, two interim analyses are prospectively planned. These will be performed after one-third and two-thirds of the @entity1 , respectively, have completed the trial. Based on the results of these interim analyses, a data monitoring committee will determine how to modify aspects of the study without undermining the validity and integrity of the trial. The primary outcome measure is the proportion of @entity1 who show a clinically significant change, which is defined as at least a 20-point improvement in angina frequency score on the Seattle Angina Questionnaire, which will be administered on day 30. Other secondary efficacy and safety outcomes will also be assessed. DISCUSSION: This trial will provide high-quality evidence regarding the use of Danhong injection to treat @entity5749 . TRIAL REGISTRATION: ClinicalTrials.gov: NCT01681316 .

Danhong injection in the treatment of XXXX : study protocol for a randomized controlled trial.

@entity1 :: ('9606', 'Species') :: ['patients', 'Participants'] @entity204 :: ('MESH:D003643', 'Disease') :: ['death'] @entity5749 :: ('MESH:D060050', 'Disease') :: ['chronic stable angina', 'Chronic stable angina']
@entity5749 :: (MESH:D060050,Disease) :: ['chronic stable angina']
