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Clinical Trial of Shugan Jieyu Capsule in Generalized Anxiety Disorder

RecruitingPhase 3Ages 18 Years - 65 YearsAllSichuan Jishengtang Pharmaceutical Co., Ltd.
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: 1. 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; 2. Age 18-65 years old; 3. Hamilton Anxiety Rating Scale (HAM-A) Total Score of ≥ 14 at both Screening and Baseline,Anxious Mood (item 1) score ≥2; 4. Clinical Global Impression of Severity Scale (CGI-S) score of ≥ 3 at both Screening and Baseline 5. The TCM syndrome is liver Qi stagnation and spleen deficiency syndrome. Exclusion Criteria: 1. Diagnosed with a psychiatric disorder other than GAD that meets DSM-5 criteria within 6 months prior to screening; 2. Alcohol or drug abuse or dependence in the 6 months prior to screening, or urine positive for multiple drugs combined at screening 3. Hamilton Depression Rating Scale (HAMD-17) Total Score of \> 17 at Screening or Baseline,or Depressive Mood (item 1) score ≥2; 4. Patients with Severe Insomnia.
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What it tests

  • Shugan Jieyu Capsules
  • Shugan Jieyu Capsules Placebo
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Where

1 site
Beijing Anding Hospital Affiliated to Capital Medical University
Beijing, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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