Evidence map›Paper›PMID 29747670›Full record

ArticleTrials2018

The efficacy and safety of Jiedu Tongluo granules for treating post-stroke depression with qi deficiency and blood stasis syndrome: study protocol for a randomized controlled trial.

Ai-Mei Zhao, Wen-Ran Qiu, Li-Jun Mao, Jun-Guo Ren, Li Xu, Ming-Jiang Yao, Kellie Bilinksi, Dennis Chang, Jian-Xun Liu

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03147053 (The Efficacy and Safety of Jiedu Tongluo Granules on Patients With Post-stroke Depression), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
1.3field-weighted citation impact, top 19% 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.

NCT03147053 early_phase1completednot on this map

The Efficacy and Safety of Jiedu Tongluo Granules on Patients With Post-stroke Depression: a Double-blind, Randomized and Placebo-controlled Trial

TypeinterventionalSponsorXiyuan Hospital of China Academy of Chinese Medical SciencesRan2017 to 2018Enrolled55ConditionsPost-stroke DepressionArmsJiedu Tongluo granules, Placebo
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 10 citations in OpenAlex.

  1. Study on subtyping and Traditional Chinese Medicine treatment of depression based on machine learning and text mining.Journal of traditional Chinese medicine = Chung i tsa chih ying wen pan · 2025
    Article
  2. Article
  3. Article
  4. Review
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 4 institutions in 2 countries.

Ai-Mei ZhaoGraduate School, Beijing University of Chinese Medicine, Beijing, 100029, China.
Wen-Ran QiuGraduate School, Beijing University of Chinese Medicine, Beijing, 100029, China.
Li-Jun MaoDepartment of Neurology, Xiyuan Hospital of China Academy of Chinese Medical Sciences, Beijing, 100091, China.
Jun-Guo RenInstitute of Basic Medical Sciences, Xiyuan Hospital of China Academy of Chinese Medical Sciences, Haidian District, Beijing, 100091, People's Republic of China.
Li XuInstitute of Basic Medical Sciences, Xiyuan Hospital of China Academy of Chinese Medical Sciences, Haidian District, Beijing, 100091, People's Republic of China.
Ming-Jiang YaoInstitute of Basic Medical Sciences, Xiyuan Hospital of China Academy of Chinese Medical Sciences, Haidian District, Beijing, 100091, People's Republic of China.
Kellie BilinksiNICM, Western Sydney University, Locked Bag 1797, Penrith, NSW, 2751, Australia.
Dennis ChangNICM, Western Sydney University, Locked Bag 1797, Penrith, NSW, 2751, Australia. d.chang@westernsydney.edu.au.
Jian-Xun LiuInstitute of Basic Medical Sciences, Xiyuan Hospital of China Academy of Chinese Medical Sciences, Haidian District, Beijing, 100091, People's Republic of China. liujx0324@163.com.
Chinese Academy of Medical Sciences & Peking Union Medical College · CNBeijing University of Chinese Medicine · CNWestern Sydney University · AUXiyuan Hospital · CN

Funding

Ministry of Science and Technology of the People's Republic of China 2012ZX09103201-015Ministry of Science and Technology of the People's Republic of China (CN) 2015CB554405
6 · The paper itself

Abstract

backgroundPost-stroke depression (PSD) is the most common psychiatric complication after a stroke. The most frequently used antidepressants are selective serotonin receptor inhibitors (SSRIs) and serotonin and norepinephrine reuptake inhibitors (SNRIs), however, these exhibit a series of side effects. Traditional Chinese medicine has been used to treat PSD with few side effects. The aim of this study is to evaluate the efficacy and safety of Jiedu Tongluo granules for treating PSD with qi deficiency and blood stasis syndrome.

methodsThe planned study is a double-blind, randomized, placebo-controlled pilot trial. Eighty participants will be randomly assigned to receive either treatment or placebo. The treatment group will receive Jiedu Tongluo granules (JDTLG) with conventional treatment, and the placebo group will receive placebo with conventional treatment for 8 weeks. The primary outcome is the effectiveness of JDTLG on depression after 8 weeks treatment, which is defined as a decrease of 50% or more in 17-item Hamilton Depression Scale (HAMD-17) score or clinical recovery (score < 7). Secondary outcomes are improvement in neurological function, degree of independence, activities of daily living, and TCM syndrome at each visit, which will be measured with National Institute of Health Stroke Scale (NIHSS), modified Rankin Scale (mRS), Barthel Index (BI) and TCM scale, respectively. Interleukin (IL)-6, IL-8, and small-molecule metabolites will be monitored to explore the mechanism of action of JDTLG on PSD. Safety measures include vital signs, results of electrocardiography, laboratory index (full blood count, kidney and liver function tests) and adverse events. DISCUSSION: The purpose of this trial is to evaluate the therapeutic effects and safety of JDTLG in individuals with PSD with concomitant qi deficiency and blood stasis syndrome. If successful, the outcome of this trial will provide a viable treatment option for PSD patients.

trial registrationClinicalTrials.gov ID: NCT03147053 . Registered on 27 April 2017.

Indexed as

Randomized Controlled Trials as TopicActivities of Daily LivingAgedAged, 80 and overDepressionDouble-Blind MethodDrugs, Chinese HerbalHumansMedication AdherenceMedicine, Chinese TraditionalMiddle AgedOutcome Assessment, Health CarePilot ProjectsStrokeDrugs, Chinese HerbaltongluoChinese herbal medicineJiedu Tongluo granulesPost-stroke depressionQi deficiency and blood stasis syndromeRandomized controlled trial

Identifiers

PMID29747670
PMCPMC5946494
OpenAlexW2806399757

What OpenQuestion holds

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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.