Randomized, Double-Blind, Placebo-Controlled, Non-inferiority Clinical Trial on the Efficacy and Safety of Houtou Jianweiling Tablet in the Treatment of Chronic Non-Atrophic Gastritis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- The improvement rate of main Clinical symptoms
研究概览
简要总结
To study the efficacy & safety of Houtou Jianweiling tablet through the non-inferiority clinical trial of Houtou Jianweiling tablet with Omeprazole Enteric-coated tablet in patients with chronic non-atrophic gastritis.
详细描述
This is a Randomized, Double-Blind, Placebo-Controlled, Non-inferiority Clinical Trial on the Efficacy and Safety of Houtou Jianweiling Tablet in the Treatment of Chronic Non-Atrophic Gastritis.
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
- Double (Participant, Investigator)
盲法说明
Double Blind
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(1) Comply with the diagnostic criteria for chronic non-atrophic gastritis.
- •(2) Age between 18 to 65 years.
- •(3) Voluntarily participate the clinical trials and sign informed consent.
排除标准
- •(1) Subjects with history of gastric surgery.
- •(2) Patients with complicated and special types of gastritis, peptic ulcer, hemorrhage, cholecystitis, cholelithiasis, dysplasia of gastric mucosa or pathological diagnosis of suspected malignant change.
- •(3) Patients with atrophy and/or intestinal metaplasia through pathological examination showed;.
- •(4) Severe primary diseases associated with cardiovascular, cerebrovascular, lung, liver, kidney and hematopoietic system (above grade II of cardiac function; Cr value above the upper limit of normal value), or serious diseases affecting their survival, such as cancer or AIDS;
- •(5) Patients who have used Chinese and Western medicine to treat chronic non-atrophic gastritis in the last two weeks;
- •(6) Subjects with psychiatric disorders or a history of alcohol/drug abuse;
- •(7) Pregnant women, woman who are preparing for pregnancy, lactating women;
- •(8) Patients who are allergic constitution or allergic to known ingredients of test drugs;
- •(9) Those who have participated in or are participating in other drug clinical trials in the past 3 months;
- •(10) The syndrome differentiation is not clear or there are too many and complicated syndromes for the subjects;
- •(11) Subjects that researchers do not consider appropriate to participate in clinical trials.
- •(12) Patients with poor compliance are not allowed to participate in this trial.
- •Those who meet one or more of the above exclusion criteria cannot be included in the clinical trial.
研究组 & 干预措施
Test group (Houtou Jianeweiling tablet )
Houtou Jianweiling tablet (0.38 g), 4 tablets taken orally at a time, 3 times a day and Omeprazole Enteric-coated placebo tablet, taken 1 tablet orally once a day before breakfast.
干预措施: Houtou Jianweiling tablet (Other)
Control group (Omeprazole enteric-coated tablet)
Omeprazole Enteric-coated tablet (20 mg), 1 tablet taken orally once a day before breakfast and Houtou Jianweiling placebo tablets, taken orally, 4 tablets at a time, 3 times a day.
干预措施: Omeprazole Tablet (Drug)
结局指标
主要结局
The improvement rate of main Clinical symptoms
时间窗: During the four-week trial period
Gastric pain assessment（VAS score): Applying the Visual Analogue Scale (VAS) i.e. 0-10 Numeric Pain Intensity Scale on a 10 cm line segment, 0 is painless, 10 is extremely painful, patients will marked in the corresponding position according to the degree of pain, and the amount of the researcher give a specific score. The grading criteria of gastralgia with VAS score will be, normal: 0 cm; mild: 1-3 cm; moderate: 4-6 cm; severe: 7-10 cm.
Physicians Global Assessment to measure quality of life (PGA)
时间窗: During the four-week trial period
Therapeutic efficacy evaluation by primary symptoms i.e. Gastric Distension on 0-6 points scoring system e.g. 0 point: None before treatment or disappeared after treatment 2 points: Slight gastric distension, from time to time, does not affect work and rest. 4 points: Gastric distension can be tolerable, attacks frequently, affecting work and rest. 6 points: The gastric distension is intolerable and persist for a long time. Often needs pain killer to relief pain.
次要结局
- Laboratory examinations(before enrollment and within 5 days after treatment)
- Blood Pressure measurement(During the 4 weeks treatment period)
- Pulse rate measurement(During the 4 weeks treatment period)
- Respiration rate measurement(During the 4 weeks treatment period)
- Body Temperature measurement(During the 4 weeks treatment period)
- Electrocardiogram(before enrollment and within 5 days after treatment)
- Stool test for H. Pylori(within 5 days after treatment)
研究者
Dr. Muhammad Raza Shah
Professor
University of Karachi