Efficacy and Safety of WPQW Granule for Overlap of NERD and IBS-D

• Status: Recruiting
• Trial end date: 2023-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Xiyuan Hospital of China Academy of Chinese Medical Sciences
• Collaborators: The First Affiliated Hospital of Henan University of Traditional Chinese Medicine; the first affiliated hospital of Liaoning university of traditional Chinese medicine; The First Affiliated Hospital of Shanxi University of Traditional Chinese Medicine; Tianjin Nankai Hospital; Yunnan Provinical Hospital of Traditional Chinese Medicine

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