title: Evaluating the effects of Danhong injection in treatment of acute ischemic stroke: study protocol for a multicenter randomized controlled trial.
abstract: BACKGROUND
  Danhong injection (DHI) has been widely prescribed to patients with acute ischemic stroke (AIS). However, due to methodological deficiencies, previous research has not yet provided rigorous evidence to support the use of DHI in the treatment of AIS. Therefore, we designed this multicenter, randomized, controlled, and double-blind trial to evaluate the efficacy and safety of DHI for AIS.
  
  
  METHODS
  It is a randomized, multicenter, double-blind, placebo-controlled, adaptive clinical trial. A total of 864 eligible patients will be randomized into either the DHI or placebo group in a 2:1 ratio. All patients will be given the standard medical care as recommended by guidelines. Participants will undergo a 2-week treatment regimen and 76-day follow-up period. The primary outcome is the proportion of patients with a favorable outcome, defined as a score of 0-1 on the modified Rankin scale at day 90. Secondary outcomes include a change in the total score of the Chinese medicine symptom scales of "Xueyu Zheng" (blood stasis syndrome), the proportion of patients with a Barthel Index score of ≥90, the proportion of patients with an improvement in NIHSS score of ≥4 or NIHSS score of 0-1, quality of life measured by the EQ-5D scale, etc. Safety outcomes such as global disability (mRS ≥3) at day 90 will also be assessed. The changes in mRNA and microRNA profiles in 96 patients selected from certain centers will also be assessed. As this is an adaptive design, two interim analyses are prospectively planned, which will be carried out after one-third and two-thirds of patients have completed the trial, respectively. Based on the results of the interim analyses, the Data Monitoring Committee (DMC) will decide how to modify the study.
  
  
  CONCLUSIONS
  This trial will provide high-quality evidence for DHI in treatment of AIS.
  
  
  BACKGROUND
  Clinical Trials.gov NCT01677208 (Date of registration 22 December 2012).
authors.affiliation: Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, 16 Nanxiaojie, Dongzhimennei, Beijing, 100700, China. libingtcm@163.com.|Institute of Information on Traditional Chinese Medicine, China Academy of Chinese Medical Sciences, 16 Nanxiaojie, Dongzhimennei, Beijing, 100700, China. libingtcm@163.com.
authors.forename: Bing
authors.initials: B
authors.lastname: Li
authors.affiliation: Beijing Tiantan Hospital Affiliated to Capital Medical University, 6 Tiantan Xili, Dongcheng District, Beijing, 100050, China. yilong528@gmail.com.
authors.forename: Yilong
authors.initials: Y
authors.lastname: Wang
authors.affiliation: Beijing Tiantan Hospital Affiliated to Capital Medical University, 6 Tiantan Xili, Dongcheng District, Beijing, 100050, China. lujingjing@gmail.com.
authors.forename: Jingjing
authors.initials: J
authors.lastname: Lu
authors.affiliation: Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, 16 Nanxiaojie, Dongzhimennei, Beijing, 100700, China. franlj1104@aliyun.com.
authors.forename: Jun
authors.initials: J
authors.lastname: Liu
authors.affiliation: Changzhou TCM Hospital, Heping North Road, Changzhou, Jiangsu, 213004, China. yuanye.198705@163.com.
authors.forename: Ye
authors.initials: Y
authors.lastname: Yuan
authors.affiliation: Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, 16 Nanxiaojie, Dongzhimennei, Beijing, 100700, China. pumpkinnaicha@163.com.
authors.forename: Yanan
authors.initials: Y
authors.lastname: Yu
authors.affiliation: Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, 16 Nanxiaojie, Dongzhimennei, Beijing, 100700, China. pengqian.wang@163.com.
authors.forename: Pengqian
authors.initials: P
authors.lastname: Wang
authors.affiliation: Beijing Tiantan Hospital Affiliated to Capital Medical University, 6 Tiantan Xili, Dongcheng District, Beijing, 100050, China. zxq@vip.163.com.
authors.forename: Xingquan
authors.initials: X
authors.lastname: Zhao
authors.affiliation: Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, 16 Nanxiaojie, Dongzhimennei, Beijing, 100700, China. zhonw@sina.com.
authors.forename: Zhong
authors.initials: Z
authors.lastname: Wang
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D002545:Brain Ischemia / Q000175:diagnosis / Q000188:drug therapy* / Q000235:genetics; D002317:Cardiovascular Agents / Q000008:administration & dosage* / Q000009:adverse effects; D002681:China; D002985:Clinical Protocols; D004185:Disability Evaluation; D004311:Double-Blind Method; D004365:Drugs, Chinese Herbal / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D020869:Gene Expression Profiling; D005819:Genetic Markers; D006801:Humans; D007267:Injections; D008297:Male; D035683:MicroRNAs / Q000235:genetics; D008875:Middle Aged; D011788:Quality of Life; D012333:RNA, Messenger / Q000235:genetics; D012107:Research Design; D020521:Stroke / Q000175:diagnosis / Q000188:drug therapy* / Q000235:genetics; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D002317:Cardiovascular Agents; D004365:Drugs, Chinese Herbal; D005819:Genetic Markers; D035683:MicroRNAs; D012333:RNA, Messenger; C540581:danhong