Clinical Trial of Shugan Jieyu Capsule in Generalized Anxiety Disorder

Last updated: December 17, 2024
Sponsor: Sichuan Jishengtang Pharmaceutical Co., Ltd.
Overall Status: Active - Recruiting

Phase

3

Condition

Panic Disorders

Anxiety Disorders

Mood Disorders

Treatment

Shugan Jieyu Capsules

Shugan Jieyu Capsules Placebo

Clinical Study ID

NCT05772104
KH109-CS01-CRP
  • Ages 18-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Primary diagnosis of generalized anxiety disorder (GAD) as per Diagnostic andStatistical Manual of Mental Disorders, Fifth Edition (DSM-5) as confirmed by theMINI at Screening, The duration of illness must be ≥ 6 months；

  2. Age 18-65 years old；

  3. Hamilton Anxiety Rating Scale (HAM-A) Total Score of ≥ 14 at both Screening andBaseline，Anxious Mood (item 1) score ≥2；

  4. Clinical Global Impression of Severity Scale (CGI-S) score of ≥ 3 at both Screeningand Baseline

  5. The TCM syndrome is liver Qi stagnation and spleen deficiency syndrome.

Exclusion

Exclusion Criteria:

  1. Diagnosed with a psychiatric disorder other than GAD that meets DSM-5 criteriawithin 6 months prior to screening；

  2. Alcohol or drug abuse or dependence in the 6 months prior to screening, or urinepositive for multiple drugs combined at screening

  3. Hamilton Depression Rating Scale (HAMD-17) Total Score of > 17 at Screening orBaseline，or Depressive Mood (item 1) score ≥2；

  4. Patients with Severe Insomnia.

Study Design

Total Participants: 495
Treatment Group(s): 2
Primary Treatment: Shugan Jieyu Capsules
Phase: 3
Study Start date:
April 17, 2023
Estimated Completion Date:
June 01, 2025

Study Description

This trial was a multi-center, randomized, double-blind, two-stage clinical trial in patients with generalized anxiety disorder (TCM differentiated as liver Qi stagnation and spleen deficiency syndrome), consisting of a exploratory study(stage 1) and a confirmatory study(stage 2).

In stage 1, 120 subjects were enrolled and randomly assigned to high-dose group, low-dose group and placebo group at a ratio of 1:1:1.

In stage 2, 495 subjects were randomly assigned to the experimental and placebo groups at a ratio of 1:1.

Connect with a study center

  • Beijing Anding Hospital Affiliated to Capital Medical University

    Beijing,
    China

    Active - Recruiting

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