Actively Recruiting
Clinical Trial of Shugan Jieyu Capsule in Generalized Anxiety Disorder
Led by Sichuan Jishengtang Pharmaceutical Co., Ltd. · Updated on 2024-12-18
495
Participants Needed
1
Research Sites
110 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Clinical Trial of Shugan Jieyu Capsule in Generalized Anxiety Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Primary diagnosis of generalized anxiety disorder (GAD) per DSM-5 confirmed by MINI at screening, with illness duration of at least 6 months
- Age between 18 and 65 years
- Hamilton Anxiety Rating Scale (HAM-A) total score of 14 or higher at screening and baseline, with Anxious Mood (item 1) score of 2 or more
- Clinical Global Impression of Severity Scale (CGI-S) score of 3 or higher at screening and baseline
- Traditional Chinese Medicine syndrome diagnosis of liver Qi stagnation and spleen deficiency syndrome
You will not qualify if you...
- Diagnosed with any psychiatric disorder other than GAD within 6 months before screening
- Alcohol or drug abuse or dependence within 6 months before screening, or positive urine test for multiple drugs at screening
- Hamilton Depression Rating Scale (HAMD-17) total score greater than 17 at screening or baseline, or Depressive Mood (item 1) score of 2 or more
- Severe insomnia
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Beijing Anding Hospital Affiliated to Capital Medical University
Beijing, China
Actively Recruiting
Research Team
L
Ling Song
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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