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Not yet recruitingNCT06481787Updated Jul 1, 2024

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

An interventional study of Vonorasan Fumarate and Zuojin Pills in Gastroesophageal Reflux Disease and Depression, sponsored by Nanjing First Hospital, Nanjing Medical University. Not yet recruiting. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-07-01.

Sponsored by Nanjing First Hospital, Nanjing Medical University · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Primary completion was expected by Apr 2026, 5 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Gastroesophageal Reflux Disease
  • Depression
03

In context

Gastroesophageal Reflux

1,067 studies on the registry are indexed under Gastroesophageal Reflux; 188 are open to participants now.

This study's planned enrollment of 300 is above the median of 72 across 712 interventional studies indexed under Gastroesophageal Reflux.

Browse Gastroesophageal Reflux studies →

Lead sponsor

Nanjing First Hospital, Nanjing Medical University is the lead sponsor of 213 studies on the registry; 106 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Aged between 18 and 65 years;
  2. Fulfilment of western medical diagnostic criteria for GERD;
  3. Meet the diagnostic criteria for mild depression;
  4. Comply with the diagnostic criteria of Liver and Stomach Depression-Heat syndrome in Chinese medicine;
  5. A score of 7-17 on the 17-item Hamilton Depression Scale (HAMD-17) (7-17 being mild depression);
  6. Good compliance and autonomous behaviour;
  7. No medications that may have an effect on the study, such as acid-suppressing agonists, were taken within 2 weeks prior to enrolment;

Exclusion criteria

Exclusion Criteria:

  1. HP positive patients;
  2. 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;
  3. Systemic diseases affecting the dynamics of the digestive tract, such as diabetes mellitus, chronic renal insufficiency, connective tissue diseases, neurological lesions, etc;
  4. Pathological diagnosis of the esophageal mucosa suggestive of moderate-to-severe heterogeneous hyperplasia;
  5. Previous surgery resulting in a decrease in gastric acid or a history of oesophageal or gastric surgery;
  6. Varicose veins in the esophagus or fundus of the stomach;
  7. Persons with severe primary heart, brain, liver, lung, kidney, blood or serious disease affecting their survival;
  8. Those with depression, suicidal tendencies and mental disorders who cannot cooperate;
  9. Pregnant or breastfeeding women, or patients who have a plan to have children in the near future;
  10. Taking drugs that have an effect on the results of this study within 2 weeks before participating in this study;
  11. Allergy or adverse reaction to the study drug.
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
300 participants (estimated)

Study arms

  • Experimental
    Vonorasan fumarate

    Vonorasan fumarate, 20 mg twice daily orally before meals for 8 weeks of treatment.

    Drug: Vonorasan Fumarate

  • Experimental
    Zuojin Pills combined with Vonorasan Fumarate

    Add Zuojin Pills, 3g each time, twice daily, on top of Vonorasan Fumarate treatment for 8 weeks.

    Drug: Vonorasan Fumarate · Drug: Zuojin Pills

Interventions

  • DrugVonorasan Fumarate

    Vonorasan fumarate is taken 30min before breakfast and dinner.

  • DrugZuojin Pills

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

06

What researchers measure

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

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 1, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06481787
Lead sponsor
Nanjing First Hospital, Nanjing Medical University
Responsible party
Sponsor
First posted
Jul 1, 2024
Start date
Jun 30, 2024 (estimated)
Primary completion
Apr 30, 2026 (estimated)
Completion
Jun 30, 2026 (estimated)
Last update
Jul 1, 2024

Study contacts

yan wang
Contact
292615568@qq.com
19801295220
wanli liu
Contact
wanli liu
study director · The First Affiliated Hospital with Nanjing Medical University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

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