A Multi-center, Randomized, Double-Blind, Placebo-Controlled Parallel Group Clinical Research of Zhizhu Kuanzhong Capsule in Treating Patients With Functional Dyspepsia-Postprandial Distress Syndrome
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Visual Analogue Score (VAS)
研究概览
简要总结
A 13 weeks randomized, double-blind and placebo parallel-controlled trial will be conducted to evaluate the clinical efficacy and safety of Zhizhu Kuanzhong Capsule in the treatment of functional dyspepsia-postprandial distress syndrome.
详细描述
This is a multi-center, randomized, double-blind, placebo parallel-controlled International clinical trial of Zhizhu Kuanzhong Capsule in treating patients with Functional Dyspepsia-Postprandial Distress Syndrome (FD-PDS).
In this study, Hong Kong Baptist University will collaborate with Xiyuan Hospital of China Academy of Chinese Medical Sciences, and will be recruiting 60 FD-PDS patients as study subjects in Hong Kong, out of the total sample size of 480 patients.
The study includes a 1 week run-in period, 8 weeks double-blind treatment period and a 4 weeks of follow up period for each eligible subject. Eligible subjects will be randomly assigned to either the trial drug or the placebo.
6 follow-up visits and 1 telephone follow-up will be scheduled for each subject on the -7 days (visit 1), enrollment on day 0 (visit 2), 14th day (visit 3), 28th day (visit 4), 42nd day (visit 5, telephone follow-up), the 56th day (visit 6) and the 84th day (visit 7) respectively.
Urine, stool and blood samples will be collected from each subject on visit 2 and visit 6 for blood, urine, stool, liver and kidney function tests.
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, Care Provider, Investigator)
盲法说明
The eligible subjects will be randomly assigned, with equal access to either the Chinese medicine treatment investigational drug group (Zhizhu Kuanzhong Capsule) or the placebo group.
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
- •Meeting the Rome IV diagnostic criteria for functional dyspepsia-postprandial distress syndrome;
- •At least 3 days during the one-week run-in period with VAS score ≥ 4 for major symptoms (at least one of postprandial fullness discomfort and early satiety) .
- •Be able to discontinue prohibited medications that may affect the evaluation of the effectiveness.
- •Written informed consent.
排除标准
- •Gastroscopic findings of gastric cancer, peptic ulcer, erosive gastritis (grade 2 or higher), moderate to severe atrophic gastritis, dysplasia, or other organ gastrointestinal disease.
- •History of abdominal surgery (except for appendectomy and cesarean section);
- •Immune system defects, or those who have been administered immunosuppressive agents or glucocorticoids within the past 3 months.
- •With combined severe cardiac and pulmonary insufficiency, insufficiency of liver (ALT/AST > 1.5 times the upper limit of the normal value), kidney insufficiency (BUN/SCr > the upper limit of the normal value), abnormal of endocrine system, abnormal hematopoietic system, and iron deficiency anemia as indicated on hematological examination.
- •With severe anxiety and depression.
- •With psychosis and mental retardation, language disorder precluding the ability of filling scales or recording symptoms.
- •Pregnancy or lactating; or patients of childbearing potential without effective contraception.
- •known to be allergic to the ingredients of this drug.
- •suspected or confirmed history of alcohol or drug abuse.
- •have participated in a clinical trial in the past 3 months.
- •deemed by the investigator as being not suitable for participation in the clinical trial.
研究组 & 干预措施
Investigational Drug Group
A 8-weeks double-blind treatment period with a Proprietary Chinese Medicine (consists of 4 kinds of Chinese herbs at 0.43g/capsule in weight), 3 capsules at one time, 3 times a day, oral administration 10-15 minutes before meals
干预措施: Investigational drug for Functional Dyspepsia-Postprandial Distress Syndrome (Drug)
Placebo Group
A 8-weeks double-blind treatment period with Placebo Capsules (at 0.43g/capsule in weight), 3 capsules at one time, 3 times a day, oral administration 10-15 minutes before meals
干预措施: Placebo capsules (Drug)
结局指标
主要结局
Visual Analogue Score (VAS)
时间窗: For 8 weeks
Subjects with the functional dyspepsia-postprandial distress syndrome are self-rated on the Visual Analogue Score (VAS) for the degree of discomfort with both symptoms of postprandial fullness and early fullness, with subjects indicating the degree of discomfort on a 10 cm ruler marked 0- "Asymptomatic or No Discomfort "and 10- "Extreme Severe or Extreme Discomfort "at its head and tail, respectively. The record is made on the diary card once a day and 7 days a week. The integral average for the sum of VAS for both two symptoms over the past week is evaluated based on the diary card content, and a 50% decrease from baseline in the integral average at 8 weeks is recorded as a response. The proportion of the response at 8 weeks after randomization is considered primary efficacy endpoint.
次要结局
- Evaluation of individual symptoms of Functional Dyspepsia(For 8 weeks)
- Overall Treatment Evaluation scale (OTE)(For 8 weeks)
- Hospital Anxiety and Depression Scale (HAD) score(At baseline, week 4 and week 8)
- Short Form-Nepean Dyspepsia Index (SFNDI)(At baseline, week 4 and week 8)
研究者
Zhong Lidan
Assistant Professor
Hong Kong Baptist University