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

• Status: Recruiting
• Trial end date: 2024-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Xiyuan Hospital of China Academy of Chinese Medical Sciences
• Collaborators: First Affiliated Hospital of Heilongjiang Chinese Medicine University; Liuzhou Hospital of Traditional Chinese Medicine; Yueyang Hospital of Integrated Traditional Chinese and Western Medicine

Criteria

Inclusion Criteria:

1. It meets the diagnostic criteria of nonerosive reflex disease(NERD)and epigastric pain syndrome(EPS)

2. It meets the diagnostic criteria of liver-stomach depression-heat syndrome of traditional Chinese medicine

3. Age between 18 and 70 years old

4. Patients have informed consent and are willing to receive corresponding treatment

Exclusion Criteria:

1. Patients with active peptic ulcer, gastrointestinal hemorrhage, severe dysplasia of gastric mucosa or suspected malignant change, achalasia or postoperative achalasia

2. There are other organic diseases of the digestive system (such as acute and chronic pancreatitis, cirrhosis, etc.), or systemic diseases that affect the gastrointestinal motility, such as hyperthyroidism, diabetes mellitus over 10 years, chronic renal insufficiency, spirit (the score of SAS and SDS shows severe anxiety or depression), nervous system diseases, etc

3. Patients with severe organ diseases such as heart, liver and kidney (such as ALT, AST more than 2 times of normal value), hematopoietic system diseases and tumors

4. HP infection was positive (bacterial culture, histological examination, urea breath test, rapid urease test and fecal antigen test were positive);

5. People with a history of gastric / abdominal surgery (excluding appendectomy);

6. Pregnant and lactating women;

7. People with a history of allergies to all the test drugs

8. Subjects who are participating in other clinical trials or have participated in other clinical trials within 4 weeks

9. Other situations that reduce the possibility of enrollment or complicate enrollment according to the judgment of the researcher, such as frequent changes in working environment and other situations that are easy to cause loss of follow-up.