Efficacy and Safety of WPQW Granule for Overlap of NERD and IBS-D
2022년 5월 10일 업데이트: 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.
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (예상)
216
단계
- 초기 1단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Fengyun Wang, M.D
- 전화번호: +86(010)62835248
- 이메일: wfy811@163.com
연구 장소
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Beijing
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Beijing, Beijing, 중국, 100091
- 모병
- Xiyuan Hospital of China Academy of Chinese Medical Sciences
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연락하다:
- Fengyun Wang, M.D
- 전화번호: +86(010)62835248
- 이메일: wfy811@163.com
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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.
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WPQW granule, 2 sachets / time, 3 times / day.
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위약 비교기: 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.
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WPQW granule simulant, 2 sachets / time, 3 times / day.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change of visual analogue scale (VAS) score of symptoms of reflux and heartburn
기간: baseline, 4 weeks during treatment period, 4 weeks during follow-up period
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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.
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baseline, 4 weeks during treatment period, 4 weeks during follow-up period
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Change of visual analogue scale (VAS) score of symptoms of abdominal pain and diarrhea
기간: baseline, 4 weeks during treatment period, 4 weeks during follow-up period
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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.
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baseline, 4 weeks during treatment period, 4 weeks during follow-up period
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change of traditional Chinese Medicine syndrome score
기간: baseline, week 2, week 4 during treatment period, week 6 and week 8 during follow-up period
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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.
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baseline, week 2, week 4 during treatment period, week 6 and week 8 during follow-up period
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Change of 36-item short-form (SF-36) score
기간: baseline, week 2, week 4 during treatment period, week 6 and week 8 during follow-up period
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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.
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baseline, week 2, week 4 during treatment period, week 6 and week 8 during follow-up period
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Change of FGI-checklist score
기간: baseline, week 2, week 4 during treatment period, week 6 and week 8 during follow-up period
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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.
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baseline, week 2, week 4 during treatment period, week 6 and week 8 during follow-up period
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Change of Hospital Anxiety and Depression Scale (HAD) score
기간: baseline, week 2, week 4 during treatment period, week 6 and week 8 during follow-up period
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Hospital Anxiety and Depression Scale (HAD) score was used to evaluate the efficacy of experimental drug.
Reduction in total score represented Improvement
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baseline, week 2, week 4 during treatment period, week 6 and week 8 during follow-up period
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
협력자
수사관
- 수석 연구원: Xudong Tang, M.D, China Academy of Chinese Medical Sciences
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2021년 12월 1일
기본 완료 (예상)
2023년 5월 1일
연구 완료 (예상)
2023년 5월 1일
연구 등록 날짜
최초 제출
2022년 5월 8일
QC 기준을 충족하는 최초 제출
2022년 5월 10일
처음 게시됨 (실제)
2022년 5월 11일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2022년 5월 11일
QC 기준을 충족하는 마지막 업데이트 제출
2022년 5월 10일
마지막으로 확인됨
2021년 12월 1일
추가 정보
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