Clinical study of Tonghua Liyan recipe in the treatment of laryngopharyngeal reflux with Qi stagnation and phlegm obstruction: A randomized, double-blind, placebo-controlled trial

Phase 1

Recruiting

• Conditions: Gastroesophageal reflux disease

• Registration Number: ITMCTR2100004876
• Lead Sponsor: Yueyang Integrated Traditional Chinese and Western Medicine Hospital affiliated to Shanghai University of Traditional Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Patients who meet the diagnostic criteria of laryngopharyngeal reflux (electronic gastroscopy and electronic laryngoscopy within 6 months before enrollment);
2. TCM syndrome differentiation of patients belongs to Qi stagnation and phlegm obstruction;
3. Patients who had not taken acid suppressants or gastrointestinal motility drugs 2 weeks before enrollment;
4. Aged 18 to 70 years, regardless of gender;
5. Patients who understand and agree to participate in this study and sign an informed consent form.

Exclusion Criteria

1. Patients have one of the following diseases: peptic ulcer, history of gastroesophageal and duodenal surgery, Zollinger-Ellison syndrome, pyloric obstruction, primary esophageal motility disorders (e.g. cardia achalasia, scleroderma, primary esophageal spasm), drug esophagitis, fungal esophagitis, gastrointestinal malignancy;
2. Patients with serious primary diseases of heart, brain, liver, lung, kidney, blood and endocrine system, which have not been effectively controlled, and patients with severe mental illness;
3. Patients who cannot take medication during pregnancy preparation, pregnancy or lactation, and patients who are allergic to the medication used in this study, and patients who cannot cooperate in taking medication and completing related records due to various circumstances;
4. Patients who have participated in or are participating in other clinical trials 2 weeks before enrollment.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reflux Symptom Index;Electronic Gastroscopy;Reflux Finding Score;Clinical Symptom Score;

Secondary Outcome Measures

Name	Time	Method
Gastroesophageal Reflux Disease Questionnaire;Salivary Pepsin;