NCT04454996

Study on the Rule and Mechanism of Treating Functional Gastrointestinal Diseases From the Perspective of Liver and Spleen

Major Achievements in Traditional Chinese Medicine Science and Technology Guidance Projects-Study on the Rule and Mechanism of Treating Functional Gastrointestinal Diseases

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Xiyuan Hospital of China Academy of Chinese Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

To clarify the changes of intestinal flora - gut - brain axis in FGIDs patients represented by NERD disharmony of liver and stomach and IBS-D disharmony of liver and spleen, and confirm that the imbalance between intestinal flora and host co-metabolism is the key to the pathogenesis of functional gastrointestinal disease. To reveal the common mechanism of regulating liver and spleen (stomach) in treating FGIDs dynamic disorder and visceral hypersensitivity by regulating intestinal flora - intestine - brain axis disorder.

Conditions

• Non-erosive Reflux Disease/Diarrheal Irritable Bowel Syndrome

Interventions

Type	Name	Description
DRUG	tong-jiang granules	This is a kind of compound Chinese medicine granules, 1 bag each time, 3 times a day, treatment for 4 weeks.
DRUG	Chang 'an II Recipe	This is Chang 'an II Prescription granule, 1 bag each time, 3 times a day, treatment for 4 weeks.
DRUG	The placebo of tong-jiang granules	This is a granule, containing 5% tongyu granule active drug,1 bag each time, 3 times a day, treatment for 4 weeks.
DRUG	The placebo of Chang 'an II Recipe	This is a granule containing 5% chang 'an II,1 bag each time, 3 times a day, treatment for 4 weeks.

Timeline

• Start date: 2020-06-25
• Primary completion: 2021-09-30
• Completion: 2022-03-30
• First posted: 2020-07-02
• Last updated: 2020-07-02

Locations

1 site across 1 country: China