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 trialReport as inadecuate




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 - Download this document for free, or read online. Document in PDF available to download.

Trials

, 15:272

First Online: 07 July 2014Received: 11 May 2014Accepted: 24 June 2014DOI: 10.1186-1745-6215-15-272

Cite this article as: Zhang, X., Chen, W., She, B. et al. Trials 2014 15: 272. doi:10.1186-1745-6215-15-272

Abstract

BackgroundChronic gastritis CG, a poorly understood entity, is a very common disease of the digestive tract and is difficult to cure. Chronic non-atrophic gastritis CNG is the most common type of CG. Even if treated with current standard chemotherapy, some patients will not be freed from this confusing disease. Many studies have shown traditional Chinese medicine TCM is more effective compared to chemotherapy in the treatment of chronic gastritis and no serious side effects have been identified. However, the studies that have been carried out were not scientifically rigorous trials. Our aim is to design a high-quality trial for a new TCM drug, the Jian-Wei-Qu-Tong Pills JWQTP, to investigate the efficacy and safety of this new drug in treating chronic non-atrophic gastritis patients with spleen and stomach qi deficiency with damp-heat stasis syndrome SSQDDSS.

Methods-DesignThis is a phase II, multicenter, parallel-group, double-blind, randomized and placebo-controlled trial. A total of 240 participants will be assigned to a high-dose group, a low-dose group or a placebo control group with a 1:1:1 ratio at five sites. Then, one dose six 1-g pills, with a variable ratio between real drug and dummy drug according to the intervention protocol, will be taken three times a day before each meal for 8 weeks. The primary outcome is the eradication rate of epigastric pain. The secondary outcome includes the changes of endoscopic examination, histopathological examination, traditional Chinese medicine symptom scores and patient-reported outcome instrument scores for chronic gastrointestinal diseases and the eradication rate of Helicobacter pylori HP.

DiscussionMany CNG patients suffer from frequent, recurrent bouts of dyspeptic symptoms. This is the first clinical trial to evaluate the safety and efficacy of JWQTP in treating CNG with SSQDDSS in a multicenter, parallel-group, double-blind, randomized and placebo-controlled manner. This trial may not only provide evidence for a phase III clinical trial, but also a vision of an alternative option for CNG treatment.

Trial registrationThe registration number, ChiCTR-TRC-14004088, was assigned by the Chinese Clinical Trial Registry on 7 January 2014.

Keywordschronic gastritis chronic non-atrophic gastritis spleen and stomach qi deficiency with damp-heat stasis syndrome Jian-Wei-Qu-Tong Pills traditional Chinese medicine randomized controlled trial AbbreviationsAEadverse event

AEFadverse event form

AIDSacquired immunodeficiency syndrome

ALPalkaline phosphatase

ALTalanine aminotransferase

ANOVAanalysis of variance

ASTaspartate aminotransferase

CFDAThe China Food and Drug Administration

CGchronic gastritis

CMChinese medicine

CMTEIChinese medicine therapeutic effect index

CNGchronic non-atrophic gastritis

Crcreatinine

CRFcase report form

ECGelectrocardiogram

FASfull analysis set

HPHelicobacter pylori

JWQTPJian-Wei-Qu-Tong Pills

LOCFlast observation carried forward

PPSper-protocol set

PROpatient-reported outcome

SAEserious adverse events

SDsyndrome differentiation

STBserum total bilirubin

SSQDDSSspleen and stomach qi deficiency with damp-heat stasis syndrome

TCMtraditional Chinese medicine

VASvisual analog scale

γ-GTγ-glutamyl transpeptidase.

Electronic supplementary materialThe online version of this article doi:10.1186-1745-6215-15-272 contains supplementary material, which is available to authorized users.

Xiao-xin Zhang, Wei-wei Chen contributed equally to this work.

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Author: Xiao-xin Zhang - Wei-wei Chen - Bin She - Rui-jie Luo - Na Shi - Ping Xue - Xiao-nan Yang - Qing Xia

Source: https://link.springer.com/







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