NCT05312463

Assessment on Effects of Tongjiang Granule in Treating Nonerosive Reflux Disease Overlapping Epigastric Pain Syndrome

Randomized Double-Blind Clinical Trial of Tongjiang Granule in the Treatment of Patients With Overlapping Gastrointestinal Symptoms of Nonerosive Reflux Disease(NERD) and Epigastric Pain Syndrome(EPS)

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 228 (estimated)
• Sponsor: Xiyuan Hospital of China Academy of Chinese Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Overlapping gastrointestinal symptoms of functional gastrointestinal diseases (FGIDs) is an internationally recognized problem in modern medical diagnosis and treatment. Such patients show more physical symptoms and worse quality of life, resulting in a huge economic burden. At present, FGIDs gastrointestinal symptoms overlap, lack of effective and systematic treatment, and the treatment goal is to improve symptoms.The study plans to carry out a multi center and large sample RCT clinical study of Tongjiang granule in the treatment of overlapping gastrointestinal symptoms of non erosive reflux disease(NERD)and epigastric pain syndrome（EPS, so as to provide high-level evidence-based evidence for the treatment of overlapping symptoms of FGIDs and form a diagnosis and treatment scheme that can be popularized.

Detailed description

Overlapping gastrointestinal symptoms of functional gastrointestinal diseases (FGIDs) is an internationally recognized modern medical treatment problem. More than 40.7% of people worldwide suffer from more than one FGIDs.Gastroesophageal reflux disease (GERD) and functional dyspepsia (FD) are common FGIDs. Clinically, the symptom overlap between GERD and FD is very common. Some studies show that 31.32% of FD and 41.15% of FD overlap GERD overlaps with FD, and the presence of FD reduces the response of GERD patients to proton pump inhibitors (PPIs).At present, the pathogenesis of gastrointestinal symptoms overlap in FGIDs is not clear, and there is a lack of effective and systematic treatment. Non erosive reflux disease (NERD) and epigastric pain syndrome (EPS) are common subtypes of GERD and FD. Nerd accounts for about 70% of GERD patients and EPS accounts for more than 50% of FD patients. Long-term use of PPI can lead to many side effects, even dependency. The treatment of traditional Chinese medicine compound has the characteristics of individualized syndrome differentiation and the advantage of "treating different diseases at the same time". It has a significant effect on the overlap of gastrointestinal symptoms in clinic.

Conditions

• Gastroesophageal Reflux
• Functional Dysphonia

Interventions

Type	Name	Description
DRUG	Tongjiang granule	Tongjiang granules, 1 bag / time, 3 times / day.
DRUG	Tongjiang granule simulant	Tongjiang granule simulant,1 bag / time, 3 times / day.

Timeline

• Start date: 2022-03-26
• Primary completion: 2023-10-01
• Completion: 2024-10-01
• First posted: 2022-04-05
• Last updated: 2022-04-05

Locations

1 site across 1 country: China