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Clinical Trial of Shugan Jieyu Capsule in Generalized Anxiety Disorder

NCT ID: NCT05772104

Last Updated: 2024-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

495 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-17

Study Completion Date

2025-06-01

Brief Summary

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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.

Detailed Description

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This trial was a multi-center, randomized, double-blind, two-stage clinical trial in patients with generalized anxiety disorder (TCM differentiated as liver Qi stagnation and spleen deficiency syndrome), consisting of a exploratory study(stage 1) and a confirmatory study(stage 2).

In stage 1, 120 subjects were enrolled and randomly assigned to high-dose group, low-dose group and placebo group at a ratio of 1:1:1.

In stage 2, 495 subjects were randomly assigned to the experimental and placebo groups at a ratio of 1:1.

Conditions

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Generalized Anxiety Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Experimental: Shugan Jieyu Capsules

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.

Group Type EXPERIMENTAL

Shugan Jieyu Capsules

Intervention Type DRUG

Oral, 4 Capsules, BID

Experimental: Shugan Jieyu Capsules Placepo

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.

Group Type PLACEBO_COMPARATOR

Shugan Jieyu Capsules Placebo

Intervention Type DRUG

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

Drug: Placebo, Oral, 1 capsule, BID

Interventions

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Shugan Jieyu Capsules

Oral, 4 Capsules, BID

Intervention Type DRUG

Shugan Jieyu Capsules Placebo

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

Drug: Placebo, Oral, 1 capsule, BID

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sichuan Jishengtang Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gang Wang, MD

Role: PRINCIPAL_INVESTIGATOR

Beijing Anding Hospital Affiliated to Capital Medical University

Locations

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Beijing Anding Hospital Affiliated to Capital Medical University

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Ling Song

Role: CONTACT

Phone: 028-81258178

Email: [email protected]

Facility Contacts

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Gang Wang

Role: primary

Other Identifiers

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KH109-CS01-CRP

Identifier Type: -

Identifier Source: org_study_id