Randomized Clinical Trial of Shugan Jieyu Capsule in Generalized Anxiety Disorder

A Multi-center, Randomized, Double-Blind Clinical Trial of Shugan Jieyu Capsule in Generalized Anxiety Disorder

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, 440 subjects (final sample size was re-estimated based on the results of stage 1) were randomly assigned to the experimental and placebo groups at a ratio of 1:1.

Study Overview

• Status: Not yet recruiting
• Conditions: Generalized Anxiety Disorder
• Intervention / Treatment: Drug: Shugan Jieyu Capsules; Drug: Shugan Jieyu Capsules+Placebo; Drug: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 560
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Ling Song; Phone Number: 028-81258178; Email: 022516@cnkh.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Shugan Jieyu Capsules; Oral, 4 Capsules, BID
Experimental: Experimental: Shugan Jieyu Capsules+Placepo; Participants received Shugan Jieyu Capsules 3 capsules + Placebo 1 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; Drug: Shugan Jieyu Capsules, Oral，3 capsules，BID Drug: Placebo, Oral, 1 capsule, BID
Placebo Comparator: Experimental: Placebo; Participants received 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: Placebo; Oral，4 capsules，BID

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in the HAM-A Total Score at Week 2, 4, and 8	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 2, 4, and 8
The Proportion of Subjects with HAM-A Total Score Reduction Rate ≥50% at week 2, 4, 8 and 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 2, 4, 8 and 12
The Proportion of Subjects with HAM-A Total Score ≤7 at week 2, 4, 8 and 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 2, 4, 8 and 12
Change From Baseline in the HAM-A Mental Anxiety Score at Week 2, 4, 8 and 12	HAM-A Mental Anxiety Score was the sum of Items 1 to 6 and Item 14 and could have ranged from 0 to 28.	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	The HAM-A Somatic Anxiety Factor Score was the sum of Items 7 to 13 and could have ranged from 0 to 28.	Change from Baseline to Week 2, 4, 8 and 12
Change From Baseline in the The World Health Organization Quality of Life (WHOQOL)-BREF at Week 2, 4, 8 and 12	The scale evaluates the quality of life in four areas: physiology, psychology, social relations and environment.	Change from Baseline to Week 2, 4, 8 and 12
Change From Baseline in the Clinical Global Impression of Severity Scale (CGI-S) at Week 2, 4, 8 and 12	The CGI-S is measures the clinician's impression of a subject's current anxiety severity considering their total clinical experience with the patient population. This measure uses a 0-7 scale, with higher scores indicating greater anxiety severity.	Change from Baseline to Week 2, 4, 8 and 12
Change From Baseline in the Clinical Global Impression of Improvement Scale (CGI-I) at Week 2, 4, 8 and 12	CGI-I measured the clinician's perception of the participant's improvement at the time of assessment compared with the baseline. Scores could have ranged from 1 (very much improved) to 7 (very much worse).	Change from Baseline to Week 2, 4, 8 and 12
Change From Baseline in the Traditional Chinese Medicine Syndrome Score Scale at Week 2, 4, 8 and 12	TCM syndrome scale was used to evaluate the changes of TCM symptoms and signs before and after treatment.	Change from Baseline to Week 2, 4, 8 and 12

Collaborators and Investigators

• Sponsor: Sichuan Jishengtang Pharmaceutical Co., Ltd.
• Investigators: Principal Investigator: Gang Wang, MD, Beijing Anding Hospital Affiliated to Capital Medical University

Study record dates

Study Major Dates

• Study Start (Anticipated): March 10, 2023
• Primary Completion (Anticipated): February 28, 2025
• Study Completion (Anticipated): June 1, 2025

Study Registration Dates

• First Submitted: March 6, 2023
• First Submitted That Met QC Criteria: March 6, 2023
• First Posted (Actual): March 16, 2023

Study Record Updates

• Last Update Posted (Actual): March 16, 2023
• Last Update Submitted That Met QC Criteria: March 6, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: KH109-CS01-CRP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No