Evidence map›Paper›PMID 30241562›Full record

ArticleTrials2018

Xue-Fu-Zhu-Yu capsule in the treatment of qi stagnation and blood stasis syndrome: a study protocol for a randomised controlled pilot and feasibility trial.

Haoqiang He, Guang Chen, Jialiang Gao, Yu Liu, Chenhao Zhang, Chao Liu, Hongzheng Li, Qingyong He, Jun Li, Jie Wang

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 NCT03091634 (The Efficacy and Safety of the Xue-Fu-Zhu-Yu Capsule in Treating qi Stagnation and Blood Stasis Syndrome), which is not on this map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
4.8field-weighted citation impact, top 6% 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.

NCT03091634 phase2completednot on this map

The Efficacy and Safety of the Xue-Fu-Zhu-Yu Capsule in Treating qi Stagnation and Blood Stasis Syndrome: a Multicenter, Double-blind, Randomized and Placebo-controlled Trial

TypeinterventionalSponsorGuang'anmen Hospital of China Academy of Chinese Medical SciencesRan2017 to 2018Enrolled120ConditionsQi Stagnation and Blood Stasis SyndromeArmsxue-fu-zhu-yu capsule, xue-fu-zhu-yu capsule simulated agent
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 29 citations in OpenAlex.

  1. Trial
  2. Review
  3. Article
  4. Article
  5. Article
  6. Article
  7. Article
  8. Review
  9. Article
  10. Mechanism ofMolecules (Basel, Switzerland) · 2018
    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

10 authors at 4 institutions in 1 country.

Haoqiang HeDepartment of Cardiology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, China.
Guang ChenDepartment of Cardiology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, China.
Jialiang GaoDepartment of Cardiology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, China.
Yu LiuDepartment of Acupuncture, Huguosi TCM Hospital Affiliated to Beijing University of Chinese Medicine, Beijing, 100035, China.
Chenhao ZhangEmergencyDepartment, Wangjing Hospital, China Academy of Chinese Medical Sciences, Beijing, 100102, China.
Chao LiuDepartment of Cardiology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, China.
Hongzheng LiDepartment of Cardiology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, China.
Qingyong HeDepartment of Cardiology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, China.
Jun LiDepartment of Cardiology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, China.
Jie WangDepartment of Cardiology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, China. wangjie0103@126.com.
Chinese Academy of Medical Sciences & Peking Union Medical College · CNGuang’anmen Hospital · CNBeijing University of Chinese Medicine · CNWangjing Hospital of China Academy of Chinese Medical Sciences · CN

Funding

Guang'anmen Hospital, China Academy of Chinese Medical Sciences 201207009
6 · The paper itself

Abstract

backgroundQi stagnation and blood stasis syndrome (QS&BSS) is one of the common Zhengs in traditional Chinese medicine (TCM), which manifests as various symptoms and signs, such as distending pain or a tingling sensation in a fixed position. In recent years, a number of clinical trials have focused on the effectiveness and safety of XFZYC in patients with a QS&BSS subtype disease, such as coronary heart disease, hyperlipidaemia, ischaemic cerebrovascular disease, gastritis, dysmenorrhoea, or arthritis, in terms of the outcomes of relevant diseases. However, there is lack of evidence of the effects of XFZYC in patients with QS&BSS with different diseases, focusing on the outcomes of Zhengs. METHODS/

designA randomised, controlled, pilot and feasibility trial will be employed in this study, using a 7-week study period. Participants will be recruited from Guang'anmen Hospital, Huguosi TCM Hospital, Wangjing Hospital in China. One hundred and twenty participants will be randomised to a treatment group (Xue-Fu-Zhu-Yu Capsule (XFZYC)) and placebo group in a 1:1 ratio. Participants included in the study must be diagnosed with Qi stagnation and blood stasis syndrome criteria. The outcome measurements will include the traditional Chinese medicine patient-reported outcome (PRO) scale for QS&BSS, the single symptom and sign scale of QS&BSS, and the pain scale of QS&BSS. The clinical data management system ( http://www.tcmcec.net /) will be used to collect and manage the data. Quality control will be used, according to Good Clinical Practice (GCP). DISCUSSION: Previous studies were expected to evaluate whether the addition of XFZYC to standard routine treatment would enhance the treatment effectiveness and improve the biomedical parameters pertaining to relevant disease. However, this trial is focused on the outcome of Zhengs, and we chose a range of outcome measurements to assess the improvement of relevant symptoms and signs. This trial is the first study designed to define and optimise the outcome measurements of Zhengs of XFZYC in the treatment of patients with QS&BSS.

trial registrationClinicalTrials.gov, NCT03091634 . Registered on 12 August 2018. Release date 6 May 2017.

Indexed as

QiAdministration, OralBlood CirculationCapsulesChinaDouble-Blind MethodDrugs, Chinese HerbalFeasibility StudiesHumansMulticenter Studies as TopicPainPilot ProjectsProspective StudiesRandomized Controlled Trials as TopicSyndromeTime FactorsCapsulesDrugs, Chinese HerbalXue-Fu-Zhu-Yu decoctionChinese medicineQi stagnation and blood stasis syndromeRandomised clinical trialXue-Fu-Zhu-Yu capsule

Identifiers

PMID30241562
PMCPMC6151047
OpenAlexW2892186296

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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.