NCT05772104 Clinical Trial of Shugan Jieyu Capsule in Generalized Anxiety Disorder
| NCT ID | NCT05772104 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Sichuan Jishengtang Pharmaceutical Co., Ltd. |
| Condition | Generalized Anxiety Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 495 participants |
| Start Date | 2023-04-17 |
| Primary Completion | 2025-02-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 495 participants in total. It began in 2023-04-17 with a primary completion date of 2025-02-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
Gang Wang, MD
PRINCIPAL INVESTIGATOR
Beijing Anding Hospital Affiliated to Capital Medical University
Frequently Asked Questions
Who can join the NCT05772104 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Generalized Anxiety Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05772104 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 495 participants.
Is NCT05772104 currently recruiting?
Yes, NCT05772104 is actively recruiting participants. Contact the research team at 022516@cnkh.com for enrollment information.
Where is the NCT05772104 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT05772104 clinical trial?
NCT05772104 is sponsored by Sichuan Jishengtang Pharmaceutical Co., Ltd.. The principal investigator is Gang Wang, MD at Beijing Anding Hospital Affiliated to Capital Medical University. The trial plans to enroll 495 participants.
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