Top

Published in:

Open Access 01-12-2018 | Study protocol

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

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

Published in: Trials | Issue 1/2018

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.

Available only for authorised users

Chan M, Leshner A, Fan TP, et al. “The art and science of traditional medicine part 1: TCM today - a case for integration” Produced by the Science/AAAS Custom Publishing Office Sponsored by Contents. Science. 2014;346(6216 Suppl):S1–S25.

Cheng CW, Wu TX, Shang HC, et al. CONSORT extension for Chinese herbal medicine formulas 2017: recommendations, explanation, and elaboration. Ann Intern Med. 2017. https://doi.org/10.7326/IsTranslatedFrom_M17-2977_1.

Hou J, Wang J, Lin C, et al. Circulating microRNA profiles differ between qi-stagnation and qi-deficiency in coronary heart disease patients with blood stasis syndrome. Evid Based Complement Alternat Med. 2014. https://doi.org/10.1155/2014/926962.

He L, Fang M, Chen L, et al. Transcriptome analysis of blood stasis syndrome in subjects with hypertension. J Tradit Chin Med. 2016;36(2):173–80.CrossRef

Chen BH, Shen CY, Su Z. Xuefu Zhuyu capsule for ischemic cerebrovascular disease in 126 cases. World Chinese Med. 2011;6(04):334.

Zhang Y, Zhou A, Liu Y, et al. Exploratory factor analysis for validating traditional Chinese syndrome patterns of chronic atrophic gastritis. Evid Based Complement Alternat Med. 2016. https://doi.org/10.1155/2016/6872890.

Bai JL, Zhang DX. Clinical observation on Xuefu Zhuyu capsule in combination with sodium hyaluronate in the treatment of knee osteoarthritis. Chinese J Tradit Med Traumatol Orthop. 2010;18(03):15–16,19.

Liu HH. “Xue Fu Zhu Yu capsule” for endometriosis dysmenorrhea in 80 cases. Shanghai J Tradit Chinese Med. 2003;37(01):37–8.

Shen BQ, Situ Y, et al. A clinical study on the treatment of chronic pelvic inflammation of qi-stagnation with blood stasis syndrome by Penyanqing capsule. Chin J Integr Med. 2005;11(4):249–54.CrossRef

10.

Chang JG, Li TY. Clinical observation on treatment of chloasma with qi stagnation and blood stasis by modified Xuefu Zhuyu decoction. Chinese J Aesth Med. 2011;20(08):1304.

11.

Qin L, Meng J, Lang Q, et al. Pattern characteristics in patients with primary liver cancer in different clinical stages. J Tradit Chin Med. 2015;35(1):47–53.CrossRef

12.

Chu FY, Wang J, Yao KW, et al. Effect of Xuefu Zhuyu capsule on the symptoms and signs and health-related quality of life in the unstable angina patients with blood-stasis syndrome after percutaneous coronary intervention: a randomized controlled trial. Chin J Integr Med. 2010. https://doi.org/10.1007/s11655-010-9999-9.

13.

Yu DY, Wei KB, Wo XD. Clinical and experimental study of xuefu zhuyu tang in treating qi stagnation and the blood stasis type of hyperlipidemia. Zhong Xi Yi Jie He Za Zhi. 1988;8(10):601.PubMed

14.

Shi LX. Observation of curative effect of Xuefu Zhuyu capsule on superficial gastritis. Shanxi Med J. 2011;40(10):1026–7.

15.

Sandra M, Claire L, Michal J, et al. CONSORT 2010 statement: extension to randomized pilot and feasibility trials. BMJ. 2016. https://doi.org/10.1136/bmj.i5239.

16.

Fihn SD, Blankenship JC, Alexander KP, et al. 2012 ACCF/AHA/ACP/AATS/PCNA/SCAI/STS guideline for the diagnosis and management of patients with stable ischemic heart disease: executive summary: a report of the American College of Cardiology Foundation/American Heart Association task force on practice guidelines, and the American College of Physicians, American Association for Thoracic Surgery, preventive cardiovascular nurses association, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons. J Am Coll Cardiol. 2012;60(24):2564–603.CrossRef

17.

Digestive Disease Branch of Chinese Medical Association. Consensus on chronic gastritis in China (Shanghai 2012). Mod Digest Interv. 2013;18:119–28.

18.

Jauch EC, Saver JL, Jr AH, et al. Guidelines for the early management of patients with acute ischemic stroke: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2013. https://doi.org/10.1161/STR.0b013e318284056a.

19.

Burnett M, Lemyre M. No. 345-primary dysmenorrhea consensus guideline. J Obstet Gynaecol Can. 2017;39(7):585–95. https://doi.org/10.1016/j.jogc.2016.12.023.CrossRefPubMed

20.

Osteoporosis Group of Chinese Orthopaedic Associationg. Chinese guideline for diagnosis and management of osteoarthritis (2018 edition). Chin J Orthop. 2018;38(12):705–15. https://doi.org/10.3760/cma.j.issn.0253-2352.2018.12.001.CrossRef

21.

Wang J, An Y, Li ZL, et al. Development of PRO scale for qi stagnation and blood stasis syndrome. Chinese J Exp Tradit Med Formulae. 2018. https://doi.org/10.13422/j.cnki.syfjx.20183101.

22.

Wang SQ, Gao Y, Wu SX. Thoughts on the clinical evaluation method of new medicine of syndrome TCM. World Chinese Med. 2014;9:1093–5.

23.

Eldabe S, Lloyd A, Verdian L, et al. Eliciting health state utilities from the general public for severe chronic pain. Eur J Health Econ. 2010. https://doi.org/10.1007/s10198-009-0178-x.

24.

Zhang X, Chen W, She B, et al. The efficacy and safety of Jian-Wei-Qu-Tong pills for the treatment of chronic non-atrophic gastritis (spleen and stomach qi deficiency with damp-heat stasis syndrome): study protocol for a phase II, randomized controlled trial. Trials. 2014;15(1):272.CrossRef

25.

Zhang YJ, Huang XY. Blood rheology and heart function between qi stagnation and qi-deficiency in coronary heart disease patients with blood stasis syndrome. Liaoning J Tradit Chinese Med. 1996. https://doi.org/10.1186/1745-6215-15-272.

26.

Wang J, Li J, Yang G. Research on the association among TCM syndrome, t-PA and PAI in serum and the risk stratification of UA. China J Tradit Chinese Med Pharmacy. 2009;24(9):1133–6.

27.

Song WY, Zhu QJ, Zhou KB, et al. Expression and clinical significance of neuropeptide Y in different TCM syndromes of vitiligo. J New Chinese Med. 2005;37(2):17–18.00.

28.

Ni YP, Chen JN. Study on relationship between the marks of inflammation and syndrome differentiation of traditional Chinese medicine in hyperlipidemia patients. Liaoning J Tradit Chinese Med. 2007;34(1):7–8.

29.

Wu HJ, Ma ZC, Gao Y, et al. Study on GAP in blood-stasis type of coronary heart disease by using proteomic technique. Chinese J Integrat Med Cardio/Cerebrovasc Dis. 2005;3(03):189–91.

30.

Zhu MD, Du WX, Wei CC, et al. Metabolomic study on coronary heart disease patients with different Chinese medicine pattern. J Tradit Chin Med. 2013;54(17):1489–93.

31.

Liu L, Cheng Y, Zhang H. Phytochemical analysis of anti-atherogenic constituents of Xue-Fu-Zhu-Yu-tang using HPLC-DAD-ESI-MS. Chem Pharm Bull. 2004;52(11):1295.CrossRef

32.

Zhang QY, Wang QL, Su JF. Angiogenesis effects of Xuefu Zhuyu decoction and VEGF protein expression of rats with acute myocardial ischemia. Chinese J Inform Tradit Chinese Med. 2011;18(2):53–4.

33.

Song J, Chen WY, Wu LY, et al. A microarray analysis of angiogenesis modulation effect of Xuefu Zhuyu decoction on endothelial cells. Chin J Integr Med. 2012. https://doi.org/10.1007/s11655-012-1143-6.

34.

Lee JJ, Hsu WH, Yen TL, et al. Traditional Chinese medicine, Xue-Fu-Zhu-Yu decoction, potentiates tissue plasminogen activator against thromboembolic stroke in rats. J Ethnopharmacol. 2011. https://doi.org/10.1016/j.jep.2011.01.033.

35.

Wang J, Yang X, Chu F, et al. The effects of Xuefu Zhuyu and Shengmai on the evolution of syndromes and inflammatory markers in patients with unstable angina pectoris after percutaneous coronary intervention: a randomised controlled clinical trial. Evid Based Complement Alternat Med. 2013. https://doi.org/10.1155/2013/896467.

36.

Xing Z, Xia Z, Peng W, et al. Xuefu Zhuyu decoction, a traditional Chinese medicine, provides neuroprotection in a rat model of traumatic brain injury via an anti-inflammatory pathway. Sci Rep. 2016. https://doi.org/10.1038/srep20040.

Title: 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
Authors: Haoqiang He
Guang Chen
Jialiang Gao
Yu Liu
Chenhao Zhang
Chao Liu
Hongzheng Li
Qingyong He
Jun Li
Jie Wang
Publication date: 01-12-2018
Publisher: BioMed Central
Published in: Trials / Issue 1/2018
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-018-2908-9

Keynote webinar | Spotlight on sleep in brain health

Springer Medicine

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

Abstract

Background

Methods/Design

Discussion

Trial registration

Keynote webinar | Spotlight on sleep in brain health

Springer Medicine

Abstract

Background

Methods/Design

Discussion

Trial registration

Please log in to get access to this content

Other articles of this Issue 1/2018

Evaluating parents’ decisions about next-generation sequencing for their child in the NC NEXUS (North Carolina Newborn Exome Sequencing for Universal Screening) study: a randomized controlled trial protocol

The cost-effectiveness and cost-utility of at-home infrared temperature monitoring in reducing the incidence of foot ulcer recurrence in patients with diabetes (DIATEMP): study protocol for a randomized controlled trial

Implementation of telemedicine for knee osteoarthritis: study protocol for a randomized controlled trial

The impact of an exercise training intervention on cortisol levels and post-traumatic stress disorder in juveniles from an Ugandan refugee settlement: study protocol for a randomized control trial

Antenatal sildenafil administration to prevent pulmonary hypertension in congenital diaphragmatic hernia (SToP-PH): study protocol for a phase I/IIb placenta transfer and safety study

ConFIRM trial - conversion of in vitro fertilization cycles to intrauterine inseminations in patients with a poor ovarian response to stimulation: a protocol for a multicentric, prospective randomized trial