About this trial
To evaluate the improvement of symptoms in patients with gastroesophageal reflux disease combined with depression (hepatic and gastric depression-heat type) by Zuojin Wan combined with vornodine fumarate regimen as a control, and to compare the adherence to the medication and the adverse reactions of the patients between the two groups.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged between 18 and 65 years;
Fulfilment of western medical diagnostic criteria for GERD;
Meet the diagnostic criteria for mild depression;
Comply with the diagnostic criteria of Liver and Stomach Depression-Heat syndrome in Chinese medicine;
Disqualifiers
HP positive patients;
Other organic diseases of the digestive system, such as peptic ulcer, peptic tumour, peptic haemorrhage, liver, gallbladder and pancreas disease, intestinal obstruction and inflammatory bowel disease;
Systemic diseases affecting the dynamics of the digestive tract, such as diabetes mellitus, chronic renal insufficiency, connective tissue diseases, neurological lesions, etc;
Pathological diagnosis of the esophageal mucosa suggestive of moderate-to-severe heterogeneous hyperplasia;
Trial design
Parallel
Treatments tested in this trial
Vonorasan Fumarate
DrugVonorasan fumarate is taken 30min before breakfast and dinner.
Zuojin Pills
DrugZuojin Pills should be taken 30min after breakfast and dinner.
Treatment groups
Trial outcomes
Primary outcomes
Reflux Disease Questionnaire
According to the frequency and severity of episodes of the main symptoms,observe the changes of reflux'disease questionnaire score before treatment and after 8 weeks of treatment.
Hamilton Depression Scale
Assessing patients for depressive symptoms
Chinese Medicine Points Scale
Assessment of TCM evidence before and after treatment
Secondary outcomes
Adverse events during treatment
Ask the patient about the occurrence of adverse events while taking the medication
Locations
Sponsors and contacts
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