Evidence map›Paper›PMID 26654631›Full record

Trial reportTrials2015

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

Bing Li, Yilong Wang, Jingjing Lu, Jun Liu, Ye Yuan, Yanan Yu, Pengqian Wang, Xingquan Zhao, Zhong Wang

2 registry-linked trialsOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 13 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 1 pooled it
4.3field-weighted citation impact, top 7% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01677208 phase4completednot on this map

A Randomized, Multi-center, Double-blind, Placebo-controlled Trial of Danhong Injection in the Treatment of Acute Ischemic Stroke

TypeinterventionalSponsorChina Academy of Chinese Medical SciencesRan2013 to 2019Enrolled1,503ConditionsAcute StrokeArmsDanhong injection, Standard medical care, placebo
NCT02870764 phase4unknown statusnot on this mapstarted 2016, after this paper: background citation

A Randomized, Double-blind, Placebo-controlled Trial of Dan-shen Extract in Patients With Stable Angina Pectoris

TypeinterventionalSponsorTaizhou Fourth People's HospitalRan2016 to 2017Enrolled156ConditionsAngina, Stable, InflammationArmsDan-shen extract, Placebo, Standard medical care
3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 1 synthesis or guideline pooled it, 21 citations in OpenAlex.

  1. Pooled it
  2. Integrated Multiomic Analysis Reveals the Therapeutic Potential of Danhong Injection in Mitigating Radiation-Induced Heart Disease by Modulating Ferroptosis.FASEB journal : official publication of the Federation of American Societies for Experimental Biology · 2025
    Article
  3. Article
  4. Article
  5. Article
  6. Article
  7. Review
  8. Article
  9. Review
  10. Application of Traditional Chinese Medicines in Postoperative Abdominal Adhesion.Evidence-based complementary and alternative medicine : eCAM · 2020
    Review
  11. Article
  12. Article
  13. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 3 institutions in 1 country.

Bing LiInstitute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, 16 Nanxiaojie, Dongzhimennei, Beijing, 100700, China. libingtcm@163.com.
Yilong WangBeijing Tiantan Hospital Affiliated to Capital Medical University, 6 Tiantan Xili, Dongcheng District, Beijing, 100050, China. yilong528@gmail.com.
Jingjing LuBeijing Tiantan Hospital Affiliated to Capital Medical University, 6 Tiantan Xili, Dongcheng District, Beijing, 100050, China. lujingjing@gmail.com.
Jun LiuInstitute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, 16 Nanxiaojie, Dongzhimennei, Beijing, 100700, China. franlj1104@aliyun.com.
Ye YuanChangzhou TCM Hospital, Heping North Road, Changzhou, Jiangsu, 213004, China. yuanye.198705@163.com.
Yanan YuInstitute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, 16 Nanxiaojie, Dongzhimennei, Beijing, 100700, China. pumpkinnaicha@163.com.
Pengqian WangInstitute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, 16 Nanxiaojie, Dongzhimennei, Beijing, 100700, China. pengqian.wang@163.com.
Xingquan ZhaoBeijing Tiantan Hospital Affiliated to Capital Medical University, 6 Tiantan Xili, Dongcheng District, Beijing, 100050, China. zxq@vip.163.com.
Zhong WangInstitute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, 16 Nanxiaojie, Dongzhimennei, Beijing, 100700, China. zhonw@sina.com.
Chinese Academy of Medical Sciences & Peking Union Medical College · CNBeijing Tian Tan Hospital · CNCapital Medical University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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. DISCUSSION: This trial will provide high-quality evidence for DHI in treatment of AIS.

trial registrationClinical Trials.gov NCT01677208 (Date of registration 22 December 2012).

Indexed as

AdolescentAdultAgedBrain IschemiaCardiovascular AgentsChinaClinical ProtocolsDisability EvaluationDouble-Blind MethodDrugs, Chinese HerbalFemaleGene Expression ProfilingGenetic MarkersHumansInjectionsMaleCardiovascular AgentsdanhongDrugs, Chinese HerbalGenetic MarkersMicroRNAsRNA, Messenger

Identifiers

PMID26654631
PMCPMC4673756
OpenAlexW2195435457

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.