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.
Highlights
Chronic gastritis (CG), a poorly understood entity, is a very common disease of the digestive tract and is difficult to cure
Chronic gastritis (CG), which is induced by various causes, is a very common disease of the digestive tract and is an inflammatory condition of the gastric mucosa [1]
Sample size calculation Based on the preliminary results of clinical research, no less than an estimated 55% total efficiency will be obtained with Jian-Wei-Qu-Tong Pills (JWQTP) treatment and approximately 30% will be obtained with the intervention of a placebo
Summary
Chronic 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. 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. Chronic gastritis (CG), which is induced by various causes, is a very common disease of the digestive tract and is an inflammatory condition of the gastric mucosa [1]. The prevalence rate in the general population remains unclear, a national multicenter cross-sectional study led by the Digestive Endoscopy Branch of Chinese Medical Association showed that 49.3% of the investigated patients (4,389/8,892) with upper gastrointestinal symptoms who underwent diagnostic upper endoscopy for the evaluation of gastrointestinal symptoms from 33 centers had CNG, which was the most common [6]. Traditional Chinese medicine (TCM), which has recently become a research focus in particular contexts, can broaden the therapeutic approaches to CNG [7,8,9,10,11]
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