Clinical Study on the Treatment of Generalized Anxiety Disorder With Chaihu Jia Longgu Muli Tang (Bupleurum Plus Dragon Bone and Oyster Shell Decoction)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 205
- 试验地点
- 1
- 主要终点
- Hamilton Anxiety Scale (HAMA)
研究概览
简要总结
The purpose of this study is to clinically observe the efficacy of Bupleurum Plus Dragon Bone and Oyster Shell Decoction in the treatment of Generalized Anxiety Disorder to improve the scores of HAMA
详细描述
Generalized Anxiety Disorder, not only results in a disturbed psychological condition, but even daily life with coworkers and family will also be disrupted. Chaihu Jia Longgu Muli Tang (Bupleurum Plus Dragon Bone and Oyster Shell Decoction), a compound Chinese herbal medicine found in "Treatise on Cold Damage", has been used for treating mental disorders with symptoms such as chest distress, irritability, being frightened, etc since the China Han dynasty. In this study, we will observe the efficacy of this formula, in order to provide an evidence-based basis for clinical observation and evaluation of Generalized Anxiety Disorder.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meets the western medical diagnostic criteria for generalized anxiety disorder;
- •The TCM diagnosis is Heat-Depressed on Shao-Yang (rè yù shǎo yáng) type;
- •Hamilton Anxiety Scale (HAMA) score ≥ 7;
- •Age 18-80 years old.
排除标准
- •Allergy to Chinese Medicine formulas;
- •Pregnant or breastfeeding;
- •Suicidal ideation and suicide attempt;
- •Substance use disorders;
- •Severe cardiovascular diseases liver diseases and kidney diseases.
研究组 & 干预措施
Bupleurum Plus Dragon Bone and Oyster Shell Decoction with sertraline
observation group
干预措施: Bupleurum Plus Dragon Bone and Oyster Shell Decoction Combined with Sertraline (Drug)
Sertraline
Control group
干预措施: Sertraline Hydrochloride Tablets (Drug)
结局指标
主要结局
Hamilton Anxiety Scale (HAMA)
时间窗: 0, 2, 4, 6 weeks
To evaluate participant's anxiety status
次要结局
- Heat-Depressed on Shaoyang scale(0, 2, 4, 6 weeks)
研究者
Lin Xiaoqian
Jiangsu Province Hospital of TCM Affiliated Hospital of Nanjing University of Chinese Medicine
Jiangsu Province Hospital of Traditional Chinese Medicine