Actively Recruiting
A Multi-center, Randomized, Double-Blind 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
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating Shugan Jieyu Capsules in a phase 3, multi-center, randomized, double-blind, placebo-controlled clinical trial for patients with generalized anxiety disorder (GAD) characterized by liver Qi stagnation and spleen deficiency syndrome in traditional Chinese medicine. The study aims to confirm the effectiveness and safety of this treatment in relieving anxiety symptoms. This trial includes an exploratory stage and a confirmatory stage to thoroughly assess the treatment outcomes. Participants are assigned to receive either Shugan Jieyu Capsules or a placebo, taking 4 capsules twice daily, once in the morning and once in the evening, with at least 8 hours between doses, for up to 12 weeks. The study is divided into two stages: the first stage includes high-dose, low-dose, and placebo groups; the second stage involves experimental and placebo groups with larger participant numbers. During the trial, researchers will monitor changes in anxiety levels using the Hamilton Anxiety Rating Scale (HAM-A) at multiple time points—weeks 2, 4, 8, and 12—as well as other assessments like quality of life and clinical global impressions. Safety and symptom improvements will be tracked closely through these evaluations, with the total participation period lasting up to 12 weeks.
CONDITIONS
Brief Title
Clinical Trial of Shugan Jieyu Capsule in Generalized Anxiety Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 65 years
- Primary diagnosis of generalized anxiety disorder (GAD) per DSM-5 confirmed by MINI
- Duration of illness at least 6 months
- Hamilton Anxiety Rating Scale (HAM-A) Total Score of 14 or higher at Screening and Baseline
- Anxious Mood (HAM-A item 1) score 2 or higher
- Clinical Global Impression of Severity Scale (CGI-S) score 3 or higher at Screening and Baseline
- Traditional Chinese Medicine syndrome of liver Qi stagnation and spleen deficiency
You will not qualify if you...
- Diagnosis of psychiatric disorder other than GAD within 6 months prior to screening
- Alcohol or drug abuse or dependence in the 6 months before screening
- Positive urine test for multiple drugs at screening
- Hamilton Depression Rating Scale (HAMD-17) Total Score greater than 17 at Screening or Baseline
- Depressive Mood (HAMD item 1) score 2 or higher
- Severe insomnia
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 weeks
Participants take Shugan Jieyu Capsules or placebo capsules orally twice daily for up to 12 weeks.
Visits at baseline, and at weeks 2, 4, 8, and 12 for assessments
Trial Site Locations
Total: 1 location
1
Beijing Anding Hospital Affiliated to Capital Medical University
Beijing, China
Actively Recruiting
Research Team
L
Ling Song
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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