Evaluating the effects of Danhong injection in treatment of acute ischemic stroke: study protocol for a multicenter randomized controlled trial

Abstract

BackgroundDanhong 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/DesignIt 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.DiscussionThis trial will provide high-quality evidence for DHI in treatment of AIS.Trial registrationClinical Trials.gov NCT01677208 (Date of registration 22 December 2012).Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-015-1076-4) contains supplementary material, which is available to authorized users.

Clinical Efficacy of Tonic Traditional Chinese Medicine Injection on Acute Cerebral Infarction: A Bayesian Network Meta‐Analysis

“…The following were secondary outcomes: the activities of daily living (ADLs) rating, interleukin-6 (IL-6) level, tumor necrosis factor- α (TNF- α ) level, the high-cut viscosity of whole blood (HCV), the low-cut viscosity of whole blood (LCV), fibrinogen (FIB) level, plasma viscosity (PV), and adverse reactions (ADRs). ADLs were assessed by the Barthel index [ 29 ]. (4) The study was designed solely as an RCT.…”

Application of Traditional Chinese Medicines in Postoperative Abdominal Adhesion

“…Chinese medicinal product approved by the China Food and Drug Administration (CFDA), which is extracted from Danshen (Radix Salviae) and Honghua (Carthami Flos) [80,81]. e main bioactive constituents in DHI include salvianic acid A, salvianic acid B, protocatechuic aldehyde, and rosmarinic acid.…”

Pseudo‐allergic compounds screened from Shengmai injection by using high‐expression Mas‐related G protein‐coupled receptor X2 cell membrane chromatography online coupled with liquid chromatography and mass spectrometry

“…Traditional Chinese medicine injection (TCMI) originated from China, which is produced under modern scientific and technological theory to extract and purify effective constituents from herbs or decoction pieces. Due to its high bioavailability, rapid, and accurate curative effect, TCMI has been playing a very important role in health protection and disease treatment in China [1–5]. However, with the increasing use of TCMIs, incidence of adverse drug reactions (ADRs) induced by TCMIs is obviously higher than any other dosage forms of traditional Chinese medicine.…”