Randomized Clinical Trial of Shugan Jieyu Capsule in Generalized Anxiety Disorder

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Primary Purpose

Status

Not yet recruiting

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Shugan Jieyu Capsules

Shugan Jieyu Capsules+Placebo

Placebo

About this trial

This is an interventional treatment trial for Generalized Anxiety Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Experimental: Shugan Jieyu Capsules

Experimental: Shugan Jieyu Capsules+Placepo

Experimental: Placebo

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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 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 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 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 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 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 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.

Full Information

NCT ID

NCT05772104

First Posted

March 6, 2023

Last Updated

March 6, 2023

Sponsor

Sichuan Jishengtang Pharmaceutical Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT05772104

Brief Title

Randomized Clinical Trial of Shugan Jieyu Capsule in Generalized Anxiety Disorder

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

March 10, 2023 (Anticipated)

Primary Completion Date

February 28, 2025 (Anticipated)

Study Completion Date

June 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sichuan Jishengtang Pharmaceutical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Generalized Anxiety Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

560 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Experimental: Shugan Jieyu Capsules

Arm Type

Experimental

Arm Description

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.

Arm Title

Experimental: Shugan Jieyu Capsules+Placepo

Arm Type

Experimental

Arm Description

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.

Arm Title

Experimental: Placebo

Arm Type

Placebo Comparator

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Shugan Jieyu Capsules

Intervention Description

Oral, 4 Capsules, BID

Intervention Type

Drug

Intervention Name(s)

Shugan Jieyu Capsules+Placebo

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Oral，4 capsules，BID

Primary Outcome Measure Information:

Title

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

Description

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.

Time Frame

Change from Baseline to Week 12

Secondary Outcome Measure Information:

Title

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

Description

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.

Time Frame

Change from Baseline to Week 2, 4, and 8

Title

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

Description

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.

Time Frame