Testing Shugan Jieyu Capsule for Generalized Anxiety Disorder

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial is a randomized, double-blind, placebo-controlled phase 3 study aimed at evaluating the effectiveness and safety of Shugan Jieyu Capsules in treating generalized anxiety disorder (GAD). The trial consists of two stages: an exploratory study with 120 participants and a confirmatory study with 495 participants, both assessing the capsules against a placebo. Participants are diagnosed with GAD and classified under traditional Chinese medicine as having liver Qi stagnation and spleen deficiency syndrome. The study will measure outcomes using standardized anxiety scales to determine the capsules' impact on symptoms.

Why it matters

Who can join: the full rules

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.

Where it's running

• Beijing Anding Hospital Affiliated to Capital Medical University
  Beijing, China Recruiting

Study contacts

• Principal investigator: Gang Wang, MD — Beijing Anding Hospital Affiliated to Capital Medical University
• Study coordinator: Ling Song
• Email: 022516@cnkh.com
• Phone: 028-81258178

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.