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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
495
Oral, 4 Capsules, BID
Drug: Shugan Jieyu Capsules Placebo, Oral，4 capsules，BID Drug: Placebo, Oral, 1 capsule, BID
Beijing Anding Hospital Affiliated to Capital Medical University
Beijing, China
RECRUITINGChange 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.
Time frame: Change from Baseline to Week 12
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.
Time frame: 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.
Time frame: 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.
Time frame: Change from Baseline to Week 2, 4, 8 and 12
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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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: Change from Baseline to Week 2, 4, 8 and 12