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01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Trials 1/2018

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

Zeitschrift:
Trials > Ausgabe 1/2018
Autoren:
Haoqiang He, Guang Chen, Jialiang Gao, Yu Liu, Chenhao Zhang, Chao Liu, Hongzheng Li, Qingyong He, Jun Li, Jie Wang
Wichtige Hinweise

Electronic supplementary material

The online version of this article (https://​doi.​org/​10.​1186/​s13063-018-2908-9) contains supplementary material, which is available to authorized users.
Haoqiang He and Guang Chen contributed equally to this work.

Abstract

Background

Qi 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/Design

A 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 registration

ClinicalTrials.gov, NCT03091634. Registered on 12 August 2018. Release date 6 May 2017.
Zusatzmaterial
Additional file 1: Standard protocol items: recommendation for interventional trials (SPIRIT) 2013 checklist: Recommended items to address in a clinical trial protocol and related documents. (PDF 171 kb)
13063_2018_2908_MOESM1_ESM.pdf
Additional file 2: Figure S1. Study flow chart. (PDF 203 kb)
13063_2018_2908_MOESM2_ESM.pdf
Additional file 3: Table S1. TCM syndrome diagnostic scale of QS&BSS. Table S2. Chinese Medicine PRO Scale in Patients of Qi-stagnation and blood-stasis Syndrome. Table S3. Single Symptom and Sign Scale of QS&BSS. Table S4. Pain Scale of QS&BSS (PDF 360 kb)
13063_2018_2908_MOESM3_ESM.pdf
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