Tongjiang Series Prescription Combined With PPIs Descending Ladder Withdrawal in Treating Nonerosive Reflux Disease

• Status: Recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Nonerosive Reflux Disease (NERD) is a common refractory gastrointestinal disease. Proton Pump Inhibitors (PPIs), the preferred drug, have poor response, single target and poor acid inhibition effect in some patients in clinical application. Long-term use of PPI can lead to many side effects, even dependency. The main Traditional Chinese Medicine (TCM)syndrome types of NERD are liver-stomach depression-heat syndrome, spleen deficiency damp-heat syndrome and cold-heat complicated syndrome. TCM syndrome differentiation treatment has the advantages of overall regulation and individualized treatment. The purpose of this study is to evaluate the safety and efficacy advantages of syndrome differentiation series prescription combined with PPIs descending ladder withdrawal in the treatment of patients who use PPIs for a long time that can not stop, and to solve the problems of multiple side effects and dependency caused by long-term use of PPIs.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Xiyuan Hospital of China Academy of Chinese Medical Sciences
• Collaborators: Guangdong Provincial Hospital of Traditional Chinese Medicine; Liuzhou Hospital of Traditional Chinese Medicine; The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine; Traditional Chinese Medicine Hospital of KUNSHAN; Wuhan No.1 Hospital
• Treatments: Famotidine

Criteria

Inclusion Criteria:

• 1. It meets the diagnostic criteria of nonerosive reflex disease(NERD)

• 2. Patients with PPIs who are effective for more than 8 weeks and relapse after discontinuation

• 3. Age between 18 and 70 years old

• 4. It meets the diagnostic criteria of liver-stomach depression-heat syndrome, spleen deficiency damp-heat syndrome and cold-heat complicated syndrome of traditional Chinese medicine

• 5. 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. Pregnant and lactating women

• 5. Patients with history of nervous system disease and mental disease

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

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