Efficacy and Safety of WPQW Granule for Overlap of NERD and IBS-D (NCT05369884) | Clinical Trial Compass
UnknownEarly Phase 1
Efficacy and Safety of WPQW Granule for Overlap of NERD and IBS-D
China216 participantsStarted 2021-12-01
Plain-language 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.
Who can participate
Age range18 Years – 70 Years
SexALL
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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
What they're measuring
1
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
2
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
Trial details
NCT IDNCT05369884
SponsorXiyuan Hospital of China Academy of Chinese Medical Sciences