Zuojin Wan Combined With Woonosan Fumarate for the Treatment of GRD Combined With Depression

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorNanjing First Hospital, Nanjing Medical University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Vonorasan Fumarate

    Drug

    Vonorasan fumarate is taken 30min before breakfast and dinner.

  • Zuojin Pills

    Drug

    Zuojin Pills should be taken 30min after breakfast and dinner.

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: Vonorasan fumarateExperimental treatment 1 intervention
Group B: Zuojin Pills combined with Vonorasan FumarateExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline and 8 weeks
2

Hamilton Depression Scale

Assessing patients for depressive symptoms

Time frame
Baseline and 8 weeks
3

Chinese Medicine Points Scale

Assessment of TCM evidence before and after treatment

Time frame
Baseline and 8 weeks

Secondary outcomes

1

Adverse events during treatment

Ask the patient about the occurrence of adverse events while taking the medication

Time frame
Baseline and 8 weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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