Shugan Jieyu Capsules / Outpatients Or Inpatients With Depression · Interventional Study

A Multicenter Real-World Study Evaluating the Efficacy and Safety of Shugan Jieyu Capsules in the Treatment of Depression

ClinicalTrials.gov · September 8, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a prospective multicenter study registration for Shugan Jieyu Capsules in depression, with planned enrollment of 400 and a primary endpoint of total effective rate by HAMD-17 at 12 weeks. No results are posted in this registry record; the study has not yet begun recruitment.

What was studied

Interventional, Single Group, Open label, Treatment purpose. Outpatients or Inpatients With Depression; age from 13 Years; to 65 Years. Intervention: Mild depression group, Moderate depression group, Severe de…. n = 400. 1 site: China.

Key findings

Safety

Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

This is a registry record for a planned multicenter study with no results posted; enrollment has not yet begun, so no evidence of efficacy or safety can be assessed.

Study design

As stated by the source record.

MethodsPrimary outcome measure: Total effective rate based on Hamilton Depression Scale-17 (HAMD-17) score at 12 weeks of treatment (assessed at From enrollment to the end of treatment at 12 weeks)

DesignInterventional, Single Group, Open label, Treatment purpose

PopulationOutpatients or Inpatients With Depression; age from 13 Years; to 65 Years

Sample size400

InterventionMild depression group, Moderate depression group, Severe de…

Setting1 site: China

Reported figures

Quoted from the source exactly as published.

Planned enrollment400

Primary outcome measureTotal effective rate based on Hamilton Depression Scale-17 (HAMD-17) score at 12 weeks of treatment

Study duration12 weeks

Caveats

This is a registry record only; no results have been reported.
Recruitment status is NOT_YET_RECRUITING; no participants enrolled.
No comparator arm is disclosed in the registry entry.
No blinding or randomization status is stated; real-world design suggests observational conduct.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Multicenter real-world design with planned enrollment of 400 participants.

Directness

moderate

Primary outcome is clinical efficacy via HAMD-17 at 12 weeks, a validated depression measure.

Consistency

insufficient

No results reported; consistency cannot be assessed.

Risk of bias

insufficient

Study not yet recruiting; no conduct details or comparator group disclosed.

Sample adequacy

moderate

Planned enrollment of 400 participants is reasonable for a phase-appropriate real-world study.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT07785284). This is a study registration, not published results. Lead sponsor: Peking University. Recruitment status: NOT_YET_RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 400 participants (ESTIMATED). Conditions: Outpatients or Inpatients With Depression. Interventions: DRUG: Shugan Jieyu Capsules. Primary outcome measures: Total effective rate based on Hamilton Depression Scale-17 (HAMD-17) score at 12 weeks of treatment , From enrollment to the end of treatment at 12 weeks. Brief summary: To observe the efficacy and safety of Shugan Jieyu Capsules in treating patients with varying degrees of depression in real-world clinical settings, and to provide data references for optimizing integrated traditional Chinese and Western medicine treatment strategies.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

NCT07785284Peking UniversityShugan Jieyu CapsulesOutpatients Or Inpatients With Depression