A Multi-center, Randomized, Double-Blind Clinical Trial of Shugan Jieyu Capsule in Generalized Anxiety Disorder
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 495
- 试验地点
- 1
- 主要终点
- Change From Baseline in the HAM-A Total Score at Week 12
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Shugan Jieyu Capsules (Drug)
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.
干预措施: Shugan Jieyu Capsules Placebo (Drug)
结局指标
主要结局
Change From Baseline in the HAM-A Total Score at Week 12
时间窗: Change from Baseline to 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.
次要结局
- Change From Baseline in the HAM-A Somatic Anxiety Score at Week 2, 4, 8 and 12(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(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(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(Change from Baseline to Week 2, 4, 8 and 12)
- The Proportion of Subjects with HAM-A Total Score Reduction Rate ≥50% at week 2, 4, 8 and 12;(Change from Baseline to Week 2, 4, 8 and 12)
- Change From Baseline in the HAM-A Total Score at Week 2, 4, and 8(Change from Baseline to Week 2, 4, and 8)
- The Proportion of Subjects with HAM-A Total Score ≤7 at week 2, 4, 8 and 12(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(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(Change from Baseline to Week 2, 4, 8 and 12)