Status:
UNKNOWN
Efficacy and Safety of WPQW Granule for Overlap of NERD and IBS-D
Lead Sponsor:
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Collaborating Sponsors:
Tianjin Nankai Hospital
Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
Conditions:
Non-erosive Reflux Disease
Diarrhea-Predominant Irritable Bowel Syndrome
Eligibility:
All Genders
18-70 years
Phase:
EARLY_PHASE1
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 NE...
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%,...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2023
Estimated Enrollment :
216 Patients enrolled
Trial Details
Trial ID
NCT05369884
Start Date
December 1 2021
End Date
May 1 2023
Last Update
May 11 2022
Active Locations (1)
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1
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, China, 100091