CI

At a glance

ClinicalIndex Comparison Record
Phase 3Recruiting· 495 target
Drug / intervention
Shugan Jieyu Capsules +1 moredrug
Likely dose
Not stated in record
Key inclusion· 7
  • ✓Primary diagnosis of GAD confirmed by MINI interview
  • ✓GAD duration ≥6 months
  • ✓Age 18-65 years
  • ✓HAM-A total score ≥14 at screening and baseline
Key exclusion· 5
  • ✕Other psychiatric disorder meeting DSM-5 criteria within 6 months prior to screening
  • ✕Alcohol or drug abuse/dependence in past 6 months or positive urine drug screen for multiple drugs
  • ✕HAMD-17 total score >17 at screening or baseline
  • ✕Depressive mood (HAMD-17 item 1) score ≥2

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05772104
NCT05772104Phase 3RecruitingUpdate OverdueUpdated 18mo ago · Completion was 16mo ago
Enrollment Stalled
Long Recruiting
Update Overdue
CompareCT.gov

A Multi-center, Randomized, Double-Blind Clinical Trial of Shugan Jieyu Capsule in Generalized Anxiety Disorder

Sichuan Jishengtang Pharmaceutical Co., Ltd.·interventional·Posted Mar 16, 2023·Updated Dec 18, 2024

In Brief

A Phase 3 clinical trial evaluating Shugan Jieyu Capsules and Shugan Jieyu Capsules Placebo for Generalized Anxiety Disorder. Currently recruiting, targeting 495 participants across 1 site.

Signals

Enrollment appears stalled

Detailed Summary

This is a randomized double-blind placebo-controlled phase 3 clinical trial to further validate the effectiveness and safety of Shugan Jieyu Capsules in treating generalized anxiety disorder.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGeneralized Anxiety Disorder
CountriesChina
Collaborators--

Timeline

Phase 3RecruitingOverdue
202420252026
First PostedMar 16, 2023
Enrollment StartApr 17, 2023
Primary CompletionFeb 28, 2025
Study CompletionJun 1, 2025
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 3.3 years ago

Interventions

Shugan Jieyu Capsulesdrug

Oral, 4 Capsules, BID

Shugan Jieyu Capsules Placebodrug

Drug: Shugan Jieyu Capsules Placebo, Oral，4 capsules，BID Drug: Placebo, Oral, 1 capsule, BID