Efficacy and Safety of WPQW Granule for Overlap of NERD and IBS-D
2022年5月10日 更新者：Xiyuan Hospital of China Academy of Chinese Medical Sciences
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial of WPQW Granule for Overlap of Non-Erosive Reflux Disease(NERD) and Diarrhea Predominant Diarrhea Irritable Bowel Syndrome(IBS-D)
Non-erosive reflux disease（NERD）and Diarrhea-Predominant Irritable Bowel Syndrome（IBS-D）are both the common refractory gastrointestinal diseases.
Patients, who suffered from overlapping symptoms of NERD and IBS-D, present more serious symptom manifestation, anxiety, and worse life quality than those with solely disease.
There is lack of effective treatment for overlapping gastrointestinal symptoms.
Traditional Chinese Medicine (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 WPQW granule for the treatment of NERD overlapping IBS-D.
研究概览
详细说明
Gastroesophageal reflux disease (GERD) is a chronic relapsing acid-peptic disorder that is caused by the reflux of gastric or duodenum content.
Non-erosive reflux disease（NERD）, which account for 70%, is the most common type of GERD in the Asian population.
Diarrhea-Predominant Irritable Bowel Syndrome（IBS-D）is the mainly subtype of IBS, and the prevalence was found to be 46% in IBS.
Both diseases aforementioned are common and frequent chronic diseases in the world, and the pathogenesis of which has not been fully defined.
Current studies have shown that GERD can present in patients with IBS, vice versa.
Up to 79% of patients with IBS co-exist with GERD-like symptoms, and 71% of patients with GERD co-exist with IBS-like symptoms.
For those patients, they suffer from more serious symptom manifestation, anxiety, and worse life quality those with solely disease.
The diagnosis and treatment of Functional gastrointestinal disorders (FGIDs) mostly based on the idea of segmental diagnosis and single-target therapy in modern medicine, and there is lack of effective treatment for overlapping gastrointestinal symptoms.
The advantages of holistic diagnosis therapy and individualized treatment in Traditional Chinese Medicine（TCM）have attracted international attention, but there is still lack of high-level evidence-based medical evidence for the treatment of symptom overlap in FGIDs in TCM.
In this study, we propose to conduct a multicenter, randomized, double-blind, placebo-controlled clinical study of WPQW granule for the treatment of NERD overlapping IBS-D to evaluate the efficacy and safety of WPQW granule with the aim of obtaining high-level evidence-based medical evidence.
研究类型
介入性
注册 (预期的)
216
阶段
- 第一阶段早期
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Fengyun Wang, M.D
- 电话号码：+86(010)62835248
- 邮箱：wfy811@163.com
学习地点
-
-
Beijing
-
Beijing、Beijing、中国、100091
- 招聘中
- Xiyuan Hospital of China Academy of Chinese Medical Sciences
-
接触：
- Fengyun Wang, M.D
- 电话号码：+86(010)62835248
- 邮箱：wfy811@163.com
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 70年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Patients diagnosed with NERD and IBS-D simultaneously
- Patients who present cardinal symptoms like reflux, heartburn, abdominal pain/bloating, diarrhea, etc
- Patients diagnosed with syndrome of intermingled cold and heat of traditional Chinese medicine
- Patients have informed consent and are willing to receive corresponding treatment
Exclusion Criteria:
- Patients with hiatal hernia
- Patients with upper gastrointestinal bleeding, peptic ulcer, gastrointestinal tumor, chronic atrophic gastritis with dysplasia
- Patients with other serious organic diseases, such as acute cardiovascular disease, acute and chronic pancreatitis, cirrhosis, abnormal liver function (transaminases more than 1.5 times of normal value), abnormal thyroid function, diabetes mellitus with a history of more than 10 years, chronic renal insufficiency, hematologic disorders, and hematologic disorders, etc
- Patients with neurological disease or psychiatric impairment like severe anxiety, depression requiring long-term drug treatment
- Patients who cannot stop taking acid suppressants for a long time
- Alcohol or drug dependency or abuse
- Pregnant or lactating women
- Patients who have a history of allergies to all the test drugs
- Patients who are participating in other clinical trials or have participated in other clinical trials within 3 months
- Patients who, in the opinion of the investigator, are not suitable to participate in clinical trial
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Experimental group
Oral administration of WPQW granule with warm water，2 sachets each time, 3 times a day, 1.5-2 hours after a meal.
The medication period was 4 weeks.
|
WPQW granule, 2 sachets / time, 3 times / day.
|
|
安慰剂比较：Control group
Oral administration of WPQW granule simulant，which containing 5% WPQW granule，with warm water，2 sachets each time, 3 times a day, 1.5-2 hours after a meal.
The medication period was 4 weeks.
|
WPQW granule simulant, 2 sachets / time, 3 times / day.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change of visual analogue scale (VAS) score of symptoms of reflux and heartburn
大体时间：baseline, 4 weeks during treatment period, 4 weeks during follow-up period
|
During the medication period, the patients recorded the reflux and heartburn episodes (frequency and duration) within 24 hours per day on the symptom diary card, and VAS scores for reflux and heartburn symptoms was calculated as the mean score of each symptom in the past week.
The episodes in the week before medication were used as the baseline, the mean score of any symptom decreased ≥50% from the baseline was recorded as response after weekly treatment, and the number of response weeks was considered effective if it was greater than 50% of the weeks of the whole treatment period.
|
baseline, 4 weeks during treatment period, 4 weeks during follow-up period
|
|
Change of visual analogue scale (VAS) score of symptoms of abdominal pain and diarrhea
大体时间：baseline, 4 weeks during treatment period, 4 weeks during follow-up period
|
During the medication period, the patients recorded the of abdominal pain (pain severity and frequency) and diarrhea (stool consistency and frequency based on Bristol stool form scale) within 24 hours per day on the symptom diary card.
VAS score was conducted for the most severe abdominal pain, and the mean score was calculated for each week, with the week of episodes prior to medication administration as the baseline.
It was considered effective when the weekly mean score decrease of at least 30% from baseline and the days of at least once type 6 or type 7 stool Bristol stool form every week decrease of at least 30% from baseline, referring to the efficacy evaluation of the technical guidelines for clinical studies of Chinese medicine for IBS published in 2017.
|
baseline, 4 weeks during treatment period, 4 weeks during follow-up period
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change of traditional Chinese Medicine syndrome score
大体时间：baseline, week 2, week 4 during treatment period, week 6 and week 8 during follow-up period
|
The symptoms related to syndrome of intermingled cold and heat were scored.
The cardinal symptom was scored 0, 2, 4, 6 and the secondary symptom scored 0, 1, 2, 3 respectively according to severity of each symptom.
Total symptom score represented the syndrome score.
Reduction in syndrome score represented Improvement.
|
baseline, week 2, week 4 during treatment period, week 6 and week 8 during follow-up period
|
|
Change of 36-item short-form (SF-36) score
大体时间：baseline, week 2, week 4 during treatment period, week 6 and week 8 during follow-up period
|
Health status was evaluated by a 36-item short-form (SF-36) containing eight health concepts.
If the score descends, it indicates that the patient's condition has improved.
|
baseline, week 2, week 4 during treatment period, week 6 and week 8 during follow-up period
|
|
Change of FGI-checklist score
大体时间：baseline, week 2, week 4 during treatment period, week 6 and week 8 during follow-up period
|
A 20-item FGI-checklist was used to evaluate comprehensive symptom severity of Functional Gastrointestinal Disorder (FGID), which covering esophageal, dyspeptic and bowel symptoms.
If the score descends, it indicates that the patient's condition has improved.
|
baseline, week 2, week 4 during treatment period, week 6 and week 8 during follow-up period
|
|
Change of Hospital Anxiety and Depression Scale (HAD) score
大体时间：baseline, week 2, week 4 during treatment period, week 6 and week 8 during follow-up period
|
Hospital Anxiety and Depression Scale (HAD) score was used to evaluate the efficacy of experimental drug.
Reduction in total score represented Improvement
|
baseline, week 2, week 4 during treatment period, week 6 and week 8 during follow-up period
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
合作者
调查人员
- 首席研究员：Xudong Tang, M.D、China Academy of Chinese Medical Sciences
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2021年12月1日
初级完成 (预期的)
2023年5月1日
研究完成 (预期的)
2023年5月1日
研究注册日期
首次提交
2022年5月8日
首先提交符合 QC 标准的
2022年5月10日
首次发布 (实际的)
2022年5月11日
研究记录更新
最后更新发布 (实际的)
2022年5月11日
上次提交的符合 QC 标准的更新
2022年5月10日
最后验证
2021年12月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.