Efficacy of Traditional Chinese Medicine Jianpi Qinghua Granule Combined With Low Dose Omeprazole in Patients With Non-erosive Reflux Disease (NERD)
试验速览
- 阶段
- 1 期
- 入组人数
- 204
- 试验地点
- 2
- 主要终点
- Change of GERD Q Scale
研究概览
简要总结
This is a double-blind,randomised,placebo-controlled clinical trial.We would like to investigate the safety and efficacy of Jianpi Qinghua granule(a Chinese herbal compound) combined with half-dose omeprazole in treatment of non-erosive reflux disease(NERD).
详细描述
This is a double-blind,randomised,placebo-controlled clinical trial.We recruit patients that suffer from non-erosive reflux disease and then divide them into two groups:treatment group and control group.Treatment group take Jianpi Qinghua granule and half-dose omeprazole for 4 weeks,control group take a normal dose of omeprazole for 4 weeks.Finally we investigate the safety of Jianpi Qinghua granule combined with half-dose omeprazole in treatment of non-erosive reflux disease(NERD),and contrast the efficacy of Jianpi Qinghua granule with omeprazole.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aging between 18 and 75 years, able to read and write Chinese;
- •Meet the criteria of diagnosis of NERD
- •GERD Q score>=8
- •Meet the TCM diagnosis of syndrome of dampness-heat due to spleen deficiency
- •Receiving no other treatments during the study;
- •Voluntarily agreeing with the study protocol and signing a written informed consent.
排除标准
- •Gastro-duodenal ulcer
- •Infections, inflammations, or obstruction of the small or large intestine
- •History of gastrointestinal cancer, or prior surgery of the stomach or intestine
- •Females who are pregnant or those lacking adequate contraception
- •Unwilling to sign the informed consent
研究组 & 干预措施
Treatment group
Participants in this group take the herbal compound of Jianpi Qinghua granules and half-dose omeprazole tablet.Jianpi Qinghua granule:one bag after 1 hour of breakfast and supper(twice a day) for 4 weeks.Half-dose omeprazole tablet:1 tablet of real omeprazole (10mg) and 1 tablet of Sham(10mg),once a day before breakfast for 4 weeks.
干预措施: Treatment group (Drug)
Control group
Participants in this group take the sham herbal granules twice a day as treatment group and two pieces of real omeprazole tablet(10mg each) once a day before breakfast for 4 weeks.
干预措施: Control group (Drug)
结局指标
主要结局
Change of GERD Q Scale
时间窗: 6 weeks
GerdQ was developed through the integration of validated questionnaires reflecting psychological problems and the data of diagnoses of GERD in primary and secondary medical institutions. GerdQ is used for the diagnosis and management of GERD with good authenticity and reliability. GerdQ has six items: heartburn, regurgitation, abdominal pain, nausea, sleep disorders and use of OTC medications. The score is evaluated according to the frequency of every item occurred in recent one week. 0 day, 1 day, 2-3 days, 4-7days respectively assessed to the score of 0, 1, 2 and 3 in the items of heartburn, regurgitation, sleep disorders and use of OTC medications. 0 day, 1 day, 2-3 days, 4-7days respectively assessed to the score of 3, 2, 1 and 0 in the items of abdominal pain and nausea.
次要结局
- Safety outcomes(6 weeks)
- Change of Patients Report Clinical Outcomes(PRO)(6 weeks)
- Change of 36-Item Short Form Survey Instrument(SF-36)(6 weeks)
- Change of TCM Syndrome Questionnaire(6 weeks)
- Change of the Hamilton Depression Scale 17 item (HAMD17)(6 weeks)