Actively Recruiting

Phase 3
Age: 18Years - 65Years
All Genders
NCT05772104

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

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

Beijing Anding Hospital Affiliated to Capital Medical University

Beijing, China

Actively Recruiting

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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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