NCT06481787

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Nanjing First Hospital, Nanjing Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Gastroesophageal reflux disease (GERD) is a common digestive disorder, and in recent years studies have shown an increasing incidence of comorbid depression in patients with GERD. The treatment of gastric acid inhibition and mucosal protection alone is not effective for patients with reflux combined with depression, and the additional administration of neuromodulatory drugs will increase the incidence of adverse reactions, so the combination of traditional Chinese medicine may be one of the effective ways to solve the above problems. The aim of this study was to compare the efficacy of Zuojin Wan combined with vunorasan fumarate with that of vunorasan fumarate alone.

Conditions

• Gastroesophageal Reflux Disease
• Depression

Interventions

Type	Name	Description
DRUG	Vonorasan Fumarate	Vonorasan fumarate is taken 30min before breakfast and dinner.
DRUG	Zuojin Pills	Zuojin Pills should be taken 30min after breakfast and dinner.

Timeline

• Start date: 2024-06-30
• Primary completion: 2026-04-30
• Completion: 2026-06-30
• First posted: 2024-07-01
• Last updated: 2024-07-01