Clinical Trial of Shugan Jieyu Capsule in Generalized Anxiety Disorder
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Shugan Jieyu Capsules, Shugan Jieyu Capsules Placebo.
- Who it may be relevant to
- Registry conditions: Generalized Anxiety Disorder. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Multi-center, Randomized, Double-Blind Clinical Trial of Shugan Jieyu Capsule in Generalized Anxiety Disorder
Overview
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.
Detailed 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.
Interventions
- Drug Shugan Jieyu Capsules
Oral, 4 Capsules, BID - Drug Shugan Jieyu Capsules Placebo
Drug: Shugan Jieyu Capsules Placebo, Oral，4 capsules，BID Drug: Placebo, Oral, 1 capsule, BID
Primary outcome measures
- Change From Baseline in the HAM-A Total Score at Week 12 [Time frame: Change from Baseline to Week 12]
Secondary outcome measures (9)
- Change From Baseline in the HAM-A Total Score at Week 2, 4, and 8 [Time frame: Change from Baseline to Week 2, 4, and 8]
- The Proportion of Subjects with HAM-A Total Score Reduction Rate ≥50% at week 2, 4, 8 and 12; [Time frame: Change from Baseline to Week 2, 4, 8 and 12]
- The Proportion of Subjects with HAM-A Total Score ≤7 at week 2, 4, 8 and 12 [Time frame: Change from Baseline to Week 2, 4, 8 and 12]
- Change From Baseline in the HAM-A Mental Anxiety Score at Week 2, 4, 8 and 12 [Time frame: Change from Baseline to Week 2, 4, 8 and 12]
- Change From Baseline in the HAM-A Somatic Anxiety Score at Week 2, 4, 8 and 12 [Time frame: Change from Baseline to Week 2, 4, 8 and 12]
- Change From Baseline in the The World Health Organization Quality of Life (WHOQOL)-BREF at Week 2, 4, 8 and 12 [Time frame: Change from Baseline to Week 2, 4, 8 and 12]
- Change From Baseline in the Clinical Global Impression of Severity Scale (CGI-S) at Week 2, 4, 8 and 12 [Time frame: Change from Baseline to Week 2, 4, 8 and 12]
- Change From Baseline in the Clinical Global Impression of Improvement Scale (CGI-I) at Week 2, 4, 8 and 12 [Time frame: Change from Baseline to Week 2, 4, 8 and 12]
- Change From Baseline in the Traditional Chinese Medicine Syndrome Score Scale at Week 2, 4, 8 and 12 [Time frame: Change from Baseline to Week 2, 4, 8 and 12]
Eligibility criteria
Inclusion criteria
- Primary diagnosis of generalized anxiety disorder (GAD) as per Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) as confirmed by the MINI at Screening, The duration of illness must be ≥ 6 months；
- Age 18-65 years old；
- Hamilton Anxiety Rating Scale (HAM-A) Total Score of ≥ 14 at both Screening and Baseline，Anxious Mood (item 1) score ≥2；
- Clinical Global Impression of Severity Scale (CGI-S) score of ≥ 3 at both Screening and Baseline
- The TCM syndrome is liver Qi stagnation and spleen deficiency syndrome.
Exclusion criteria
- Diagnosed with a psychiatric disorder other than GAD that meets DSM-5 criteria within 6 months prior to screening；
- Alcohol or drug abuse or dependence in the 6 months prior to screening, or urine positive for multiple drugs combined at screening
- Hamilton Depression Rating Scale (HAMD-17) Total Score of > 17 at Screening or Baseline，or Depressive Mood (item 1) score ≥2；
- Patients with Severe Insomnia.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Beijing Anding Hospital Affiliated to Capital Medical University — Beijing
Identifiers
NCT: NCT05772104 · KH109-CS01-CRP