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首页> 外文期刊>Trials >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
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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

机译：健胃祛痛丸治疗慢性非萎缩性胃炎（脾胃气虚兼湿热瘀证）的疗效和安全性：II期研究方案，随机对照试验

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Background 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. 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/Design This 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). Discussion Many 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 registration The registration number, ChiCTR-TRC-14004088 , was assigned by the Chinese Clinical Trial Registry on 7 January 2014.
机译：背景慢性胃炎（CG）是一种鲜为人知的实体，是一种非常常见的消化道疾病，很难治愈。慢性非萎缩性胃炎（CNG）是最常见的CG类型。即使使用当前的标准化学疗法治疗，某些患者也无法摆脱这种令人困惑的疾病。许多研究表明，与化学疗法相比，中药（TCM）在治疗慢性胃炎方面更为有效，而且尚未发现严重的副作用。但是，已经进行的研究不是科学严格的试验。我们的目的是设计一种新的中药新药-健胃祛痛丸（JWQTP），以研究该新药治疗慢性非萎缩性胃炎，脾胃虚弱的患者的疗效和安全性。胃气虚湿热瘀证（SSQDDSS）。方法/设计这是II期，多中心，平行组，双盲，随机和安慰剂对照试验。总共有240名参与者被分配到五个地点的高剂量组，低剂量组或安慰剂对照组，比例为1：1：1。然后，将根据干预方案在真实药物与假药物之间的比例可变的一剂剂量（六个1克药丸）在每顿饭前每天3次，共8周。主要结局是消除上腹痛的发生率。次要结果包括内窥镜检查，组织病理学检查，中医症状评分和患者报告的慢性胃肠道疾病的结果仪器评分的变化以及幽门螺杆菌（HP）的根除率。讨论许多CNG患者常有反复发作的消化不良症状。这是第一个评估JWQTP以多中心，平行组，双盲，随机和安慰剂对照方式用SSQDDSS治疗CNG的安全性和有效性的临床试验。该试验不仅可以为III期临床试验提供证据，而且可以为CNG治疗的替代选择提供一个愿景。试验注册中国临床试验注册中心于2014年1月7日分配了注册号ChiCTR-TRC-14004088。

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