Clinical Trial of Shugan Jieyu Capsule in Generalized Anxiety Disorder

NCT05772104 | Recruiting Phase 3

• 1 other identifier: KH109-CS01-CRP
• Study Type: interventional
• Target: 495
• Locations: 1 country
• Sites: 1

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.

Conditions

Generalized Anxiety Disorder

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in the HAM-A Total Score at Week 12

  The Hamilton Anxiety Rating Scale (HAM-A) is a clinician-administered scale which consists of 14 items, each rated on a five point scale ranging from 0 (not present) to 4 (very severe). The highest possible score is 56, which represents the most severe form of anxiety; the lowest possible score is 0, which represents an absence of anxiety.

  Change from Baseline to Week 12

Secondary Outcomes (9)

• Change From Baseline in the HAM-A Total Score at Week 2, 4, and 8

  Change from Baseline to Week 2, 4, and 8

• The Proportion of Subjects with HAM-A Total Score Reduction Rate ≥50% at week 2, 4, 8 and 12;

  Change from Baseline to Week 2, 4, 8 and 12

• The Proportion of Subjects with HAM-A Total Score ≤7 at week 2, 4, 8 and 12

  Change from Baseline to Week 2, 4, 8 and 12

• Change From Baseline in the HAM-A Mental Anxiety Score at Week 2, 4, 8 and 12

  Change from Baseline to Week 2, 4, 8 and 12

• Change From Baseline in the HAM-A Somatic Anxiety Score at Week 2, 4, 8 and 12

  Change from Baseline to Week 2, 4, 8 and 12

Study Arms (2)

Experimental: Shugan Jieyu Capsules

EXPERIMENTAL

Participants received Shugan Jieyu Capsules 4 capsules,BID,once in the morning and once in the evening, at an interval of more than 8 hours, for up tp 12 weeks.

Drug: Shugan Jieyu Capsules

Experimental: Shugan Jieyu Capsules Placepo

PLACEBO COMPARATOR

Participants received Shugan Jieyu Capsules Placebo 4 capsules,BID,once in the morning and once in the evening, at an interval of more than 8 hours, for up tp 12 weeks.

Drug: Shugan Jieyu Capsules Placebo

Interventions

Shugan Jieyu Capsules DRUG

Oral, 4 Capsules, BID

Experimental: Shugan Jieyu Capsules

Shugan Jieyu Capsules Placebo DRUG

Drug: Shugan Jieyu Capsules Placebo, Oral，4 capsules，BID Drug: Placebo, Oral, 1 capsule, BID

Experimental: Shugan Jieyu Capsules Placepo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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；
• Age 18-65 years old；
• Hamilton Anxiety Rating Scale (HAM-A) Total Score of ≥ 14 at both Screening and Baseline，Anxious Mood (item 1) score ≥2；
• Clinical Global Impression of Severity Scale (CGI-S) score of ≥ 3 at both Screening and Baseline
• The TCM syndrome is liver Qi stagnation and spleen deficiency syndrome.

You may not qualify if:

• Diagnosed with a psychiatric disorder other than GAD that meets DSM-5 criteria within 6 months prior to screening；
• Alcohol or drug abuse or dependence in the 6 months prior to screening, or urine positive for multiple drugs combined at screening
• Hamilton Depression Rating Scale (HAMD-17) Total Score of \> 17 at Screening or Baseline，or Depressive Mood (item 1) score ≥2；
• Patients with Severe Insomnia.

Sponsors & Collaborators

• Sichuan Jishengtang Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Beijing Anding Hospital Affiliated to Capital Medical University

Beijing, China

RECRUITING

MeSH Terms

Conditions

Generalized Anxiety Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Study Officials

• Gang Wang, MD

  Beijing Anding Hospital Affiliated to Capital Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ling Song

CONTACT

028-81258178; 022516@cnkh.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2023
• First Posted: March 16, 2023
• Study Start: April 17, 2023
• Primary Completion: February 28, 2025
• Study Completion: June 1, 2025
• Last Updated: December 18, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)