Randomized Clinical Trial of Shugan Jieyu Capsule in Generalized Anxiety Disorder

Generalized Anxiety Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05772104
• Other study ID #: KH109-CS01-CRP
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: March 10, 2023
• Est. completion date: June 1, 2025

Study information

• Verified date: March 2023
• Source: Chengdu Kanghong Pharmaceutical Group Co., Ltd.
• Contact: Ling Song
• Phone: 028-81258178
• Email: 022516[@]cnkh.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 560
• Est. completion date: June 1, 2025
• Est. primary completion date: February 28, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety Disorders
• Generalized Anxiety Disorder

Intervention

Drug:
• Shugan Jieyu Capsules
Oral, 4 Capsules, BID
• Shugan Jieyu Capsules+Placebo
Drug: Shugan Jieyu Capsules, Oral,3 capsules,BID Drug: Placebo, Oral, 1 capsule, BID
• Placebo
Oral,4 capsules,BID

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sichuan Jishengtang Pharmaceutical Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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