A Single-centre Randomised Controlled Study of 8-week Zuojinwan in Combination With Volnoxan Fumarate for the Treatment of Gastro-oesophageal Reflux Disease Combined With Depression
Sponsor study identifier
interventional
300
0 countries
N/A
Study Start
June 30, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
April 30, 2026
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Study Completion
June 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 25, 2024
Actual (reported)June 30, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
July 1, 2024
Actual (reported)April 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
June 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Baseline and 8 weeks
Hamilton Depression Scale
Assessing patients for depressive symptoms
Baseline and 8 weeks
Chinese Medicine Points Scale
Assessment of TCM evidence before and after treatment
Baseline and 8 weeks
Adverse events during treatment
Baseline and 8 weeks
Vonorasan fumarate, 20 mg twice daily orally before meals for 8 weeks of treatment.
Add Zuojin Pills, 3g each time, twice daily, on top of Vonorasan Fumarate treatment for 8 weeks.
Vonorasan fumarate is taken 30min before breakfast and dinner.
Zuojin Pills should be taken 30min after breakfast and dinner.
wanli liu
The First Affiliated Hospital with Nanjing Medical University
wanli liu
CONTACT
First Submitted
June 25, 2024
First Posted
July 1, 2024
Study Start
June 30, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
April 30, 2026
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Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
July 1, 2024
Record last verified: 2024-06
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