Clinical trial NCT05369884: Efficacy and Safety of WPQW Granule for Overlap of NERD and IBS-D
Official title: 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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Non-erosive Reflux Disease
Diarrhea-Predominant Irritable Bowel Syndrome
Lead sponsor: Xiyuan Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
Collaborators: name: Tianjin Nankai Hospital
name: Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
name: The First Affiliated Hospital of Shanxi University of Traditional Chinese Medicine
name: The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
name: Yunnan Provinical Hospital of Traditional Chinese Medicine
First posted: 2022-05-11
Enrollment: 216
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Patients diagnosed with NERD and IBS-D simultaneously
2. Patients who present cardinal symptoms like reflux, heartburn, abdominal pain/bloating, diarrhea, etc
3. Patients diagnosed with syndrome of intermingled cold and heat of traditional Chinese medicine
4. Patients have informed consent and are willing to receive corresponding treatment

Exclusion Criteria:

1. Patients with hiatal hernia
2. Patients with upper gastrointestinal bleeding, peptic ulcer, gastrointestinal tumor, chronic atrophic gastritis with dysplasia
3. 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
4. Patients with neurological disease or psychiatric impairment like severe anxiety, depression requiring long-term drug treatment
5. Patients who cannot stop taking acid suppressants for a long time
6. Alcohol or drug dependency or abuse
7. Pregnant or lactating women
8. Patients who have a history of allergies to all the test drugs
9. Patients who are participating in other clinical trials or have participated in other clinical trials within 3 months
10. Patients who, in the opinion of the investigator, are not suitable to participate in clinical trial

Primary outcomes:
measure: Change of visual analogue scale (VAS) score of symptoms of reflux and heartburn
timeFrame: baseline, 4 weeks during treatment period, 4 weeks during follow-up period
measure: Change of visual analogue scale (VAS) score of symptoms of abdominal pain and diarrhea
timeFrame: baseline, 4 weeks during treatment period, 4 weeks during follow-up period
Secondary outcomes:
measure: Change of traditional Chinese Medicine syndrome score
timeFrame: baseline, week 2, week 4 during treatment period, week 6 and week 8 during follow-up period
measure: Change of 36-item short-form (SF-36) score
timeFrame: baseline, week 2, week 4 during treatment period, week 6 and week 8 during follow-up period
measure: Change of FGI-checklist score
timeFrame: baseline, week 2, week 4 during treatment period, week 6 and week 8 during follow-up period
measure: Change of Hospital Anxiety and Depression Scale (HAD) score
timeFrame: baseline, week 2, week 4 during treatment period, week 6 and week 8 during follow-up period
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xiyuan Hospital of China Academy of Chinese Medical Sciences
state: Beijing
Study officials:
affiliation: China Academy of Chinese Medical Sciences
name: Xudong Tang, M.D
role: PRINCIPAL_INVESTIGATOR
References: