RecruitingPhase 3NCT05772104
Clinical Trial of Shugan Jieyu Capsule in Generalized Anxiety Disorder
A Multi-center, Randomized, Double-Blind Clinical Trial of Shugan Jieyu Capsule in Generalized Anxiety Disorder
Sponsor
Sichuan Jishengtang Pharmaceutical Co., Ltd.
Enrollment
495 participants
Start Date
Apr 17, 2023
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 YearsMax Age: 65 Years
Inclusion Criteria5
- 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 Criteria4
- 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.
Interventions
DRUGShugan Jieyu Capsules
Oral, 4 Capsules, BID
DRUGShugan Jieyu Capsules Placebo
Drug: Shugan Jieyu Capsules Placebo, Oral，4 capsules，BID Drug: Placebo, Oral, 1 capsule, BID
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05772104
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