Efficacy and Safety of Jianpi Qinghua Granules in Patients With Nonerosive Reflux Disease:a Multicenter,Randomized, Double-blind, Placebo-controlled Clinical Trial
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Change of visual analogue (VAS) score of reflux symptoms and heartburn
研究概览
简要总结
Nonerosive reflux disease (NERD) is a common refractory gastrointestinal disease. Proton pump inhibitors (PPIs), the first choice drug, have the following problems in clinical use: about 50 % of patients have no response to PPIs; the efficacy of simple acid suppression is poor; long-term use of PPIs can lead to indigestion, gastric polyps, atrophic gastritis, intestinal dysbacteriosis. Spleen Deficiency and Damp-heat Syndrome is one of the common clinical syndrome of NERD.TCM syndrome differentiation and treatment has the advantages of overall regulation and individualized treatment, but lack of high-level evidence. The purpose of this study is to evaluate the efficacy and safety of Jianpi Qinghua Granules for treating NERD with spleen deficiency and damp heat syndrome.
详细描述
Nonerosive reflux disease (NERD), representing about 70% of gastroesophageal reflux disease, is a common refractory gastrointestinal disease. Proton pump inhibitors (PPIs), the first choice drug, have the following problems in clinical use: about 50 % of patients have no response to PPIs; the efficacy of simple acid suppression is poor; long-term use of PPIs can lead to indigestion, gastric polyps, atrophic gastritis, intestinal dysbacteriosis. Spleen Deficiency and Damp-heat Syndrome is one of the common clinical syndrome of NERD.TCM syndrome differentiation and treatment has the advantages of overall regulation and individualized treatment, but lack of high-level evidence. NERD is the result of multifactorial pathogenicity. The reflux symptoms not only related to acid reflux, but also related to alkali, gas, mixed reflux, etc. The theory of Tongjiang put forward by Academician Dong Jianhua.Under the guidance of Academician Dong Jianhua, the research team create a prescription Jianpi Qinghua granule for treating NERD with spleen deficiency and damp-heat syndrome. The purpose of this study is to evaluate the efficacy and safety of Jianpi Qinghua Granules for treating NERD with spleen deficiency and damp heat syndrome based on a a multicenter,randomized, double-blind, placebo-controlled clinical trial.
On the basis of previous work, the project plans to establish sub centers in 3 Chinese hospitals, including78 patients with NERD and spleen deficiency and damp-heat syndrome. The therapeutic effects were evaluated from the following aspects: the VAS score of reflow and heartburn, the rate of discontinuation of antacids, the rate of recurrence of NERD symptoms, the score of TCM syndromes and the improvement of gastrointestinal function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects diagnosed with non-erosive reflux disease
- •Subjects who have a medical history of PPI with poor therapeutic effect
- •Subjects aged between 18 and 70 years
- •Subjects diagnosed with spleen deficiency damp-heat syndrome of traditional Chinese medicine
- •Subjects who voluntarily signed written informed consent form
排除标准
- •Subjects who have active peptic ulcer, gastrointestinal hemorrhage, severe dysplasia of gastric mucosa or suspected malignant change, achalasia or postoperative achalasia
- •Subjects who have organic diseases of the digestive system (such as acute and chronic pancreatitis, cirrhosis, etc.), or systemic diseases that affect the gastrointestinal motility, such as hyperthyroidism, diabetes mellitus over 10 years, chronic renal insufficiency, spirit (the score of SAS and SDS shows severe anxiety or depression), nervous system diseases, etc
- •Subjects who have severe organ diseases such as heart, liver and kidney (such as ALT, AST more than 2 times of normal value), hematopoietic system diseases and tumors
- •Pregnant or lactating women
- •Subjects who have a history of nervous system disease and mental disease
- •Subjects who have a history of allergies to all the test drugs
- •Subjects who are participating in other clinical trials or have participated in other clinical trials within 4 weeks
研究组 & 干预措施
Experimental group
Jianpi Qinghua granules, 3 times a day and 1 hour after a meal
干预措施: Jianpi Qinghua granules (Drug)
Control group
Jianpi Qinghua placebo granules(inclued 5% of experimental drug),3 times a day and 1 hour after a meal
干预措施: Jianpi Qinghua placebo granules (Drug)
结局指标
主要结局
Change of visual analogue (VAS) score of reflux symptoms and heartburn
时间窗: week 1, week 2，week 3, week 4 during treatment period, week 6 and week 8 during follow-up period
During the treatment, the patients recorded the reflux and heartburn attacks (attack times and duration) within 24 hours every day on the symptom diary card, and VAS scores were performed on the reflux and heartburn symptoms. The average score of each symptom in the past week was calculated. The decrease rate of symptom score≥50% from baseline was recorded as response after 1 week of treatment , and the number of response weeks was more than 50% of the whole treatment period, which was considered effective.
次要结局
- Change of secondary symptom score(week 2, week 4 during treatment period, week 6 and week 8 during follow-up period)
- Change of patient ported outcome (PRO) for chronic gastrointestinal disease scale score(week 2, week 4 during treatment period, week 6 and week 8 during follow-up period)
- Change of traditional Chinese Medicine syndrome score(week 2, week 4 during treatment period, week 6 and week 8 during follow-up period)
- Change of gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) scale score(week 2, week 4 during treatment period, week 6 and week 8 during follow-up period)
- Change of self-rating anxiety scale (SAS) score(week 2, week 4 during treatment period, week 6 and week 8 during follow-up period)
- Change of self-rating depression scale (SDS) score(week 2, week 4 during treatment period, week 6 and week 8 during follow-up period)