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 range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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
. 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