PMID- 34797293
OWN - NLM
STAT- MEDLINE
DCOM- 20220124
LR  - 20230103
IS  - 1536-5964 (Electronic)
IS  - 0025-7974 (Print)
IS  - 0025-7974 (Linking)
VI  - 100
IP  - 46
DP  - 2021 Nov 19
TI  - Effect of Danhong injection on neurological recovery and adverse events in 
      patients with acute ischemic stroke: A protocol for a randomized, double-blind, 
      placebo-controlled clinical study.
PG  - e27683
LID - 10.1097/MD.0000000000027683 [doi]
LID - e27683
AB  - BACKGROUND: Acute ischemic stroke (AIS) is characterized by high disabling and 
      recurrent recurrence, and its severe neurological impairment and vascular adverse 
      events (AEs) limit the recovery of patients. Danhong injection is a complementary 
      alternative to the treatment of AIS, and previous studies have demonstrated its 
      efficacy and safety. However, there is no long-term follow-up and rigorous 
      clinical study to evaluate the effect of Danhong injection on neurological 
      recovery and AEs in patients with AIS. METHODS: This is a prospective randomized, 
      double-blind, placebo-controlled trial investigating the effect of Danhong 
      injection on neurological recovery and AEs in patients with AIS. Participants 
      were randomly divided into treatment and control groups in a 1:1 ratio. The 
      treatment group was treated with Danhong injection and the control group were 
      treated with placebo under the guideline recommended basic treatment. After 
      14 days of continuous treatment, the follow-up period was 6 months. Observation 
      indicators include: National Institute of Health Stroke Scale, modified Rankin 
      scale, symptomatic intracranial hemorrhage, the incidence of new major vascular 
      events within 6 months, and all-cause mortality. Finally, the data were analyzed 
      statistically using the SPASS 22.0 software. DISCUSSION: This study will evaluate 
      the effect of Danhong injection on neurological recovery and AEs in AIS. The 
      results will provide a reference for the clinical use of AIS.
CI  - Copyright (c) 2021 the Author(s). Published by Wolters Kluwer Health, Inc.
FAU - Gao, Junfeng
AU  - Gao J
AUID- ORCID: 0000-0001-9642-0971
AD  - Hai'an Hospital Affiliated to Nantong Medical College, Hai'an, Jiangsu Province, 
      China.
FAU - Shao, Xiangzhong
AU  - Shao X
FAU - Guan, YiXiang
AU  - Guan Y
FAU - Mei, Juxiang
AU  - Mei J
LA  - eng
GR  - No. Z2019033/Hai'an science and technology plan project/
PT  - Clinical Trial Protocol
PT  - Journal Article
PL  - United States
TA  - Medicine (Baltimore)
JT  - Medicine
JID - 2985248R
RN  - 0 (Drugs, Chinese Herbal)
RN  - 0 (danhong)
SB  - IM
MH  - Brain Ischemia/drug therapy
MH  - Double-Blind Method
MH  - Drugs, Chinese Herbal/*administration & dosage/therapeutic use
MH  - Humans
MH  - Ischemic Stroke/*drug therapy
MH  - Randomized Controlled Trials as Topic
PMC - PMC8601334
COIS- The authors have no conflicts of interest to disclose.
EDAT- 2021/11/20 06:00
MHDA- 2022/01/27 06:00
PMCR- 2021/11/19
CRDT- 2021/11/19 12:15
PHST- 2021/10/17 00:00 [received]
PHST- 2021/10/18 00:00 [accepted]
PHST- 2021/11/19 12:15 [entrez]
PHST- 2021/11/20 06:00 [pubmed]
PHST- 2022/01/27 06:00 [medline]
PHST- 2021/11/19 00:00 [pmc-release]
AID - 00005792-202111190-00023 [pii]
AID - MD-D-21-07063 [pii]
AID - 10.1097/MD.0000000000027683 [doi]
PST - ppublish
SO  - Medicine (Baltimore). 2021 Nov 19;100(46):e27683. doi: 
      10.1097/MD.0000000000027683.