Department of Mental Diseases, Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, 200071, China.
Pain Management Centre, Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, 200071, China.
Trials. 2020 Jan 23;21(1):107. doi: 10.1186/s13063-020-4057-1.
Anxiety disorders are the most prevalent class of lifetime disorders in China, and generalized anxiety disorder (GAD) is one of the most common but frequently overlooked anxiety disorders. Conventional pharmacological treatments for GAD have varying degrees of side effects, dependency, and/or withdrawal syndromes. Traditional Chinese medicine (TCM) is considered a valuable therapeutic option for anxiety disorders and a potentially effective technique to reduce the side effects associated with antipsychotic drugs. This trial aimed to evaluate the clinical efficacy and safety of Antianxiety Granule, a granular Chinese medicine compound, for treatment of GAD.
METHODS/DESIGN: The current work is a multicentre, randomized, double-blind, placebo-controlled, parallel-group clinical trial with a 6-week treatment schedule. The study consists of three periods: a 1-7-day screening period, a 6-week primary treatment period, and a 1-week follow-up period. Follow-up assessments will be conducted 1 week after the last visit with a face-to-face interview or by telephone. The clinical efficacy of Antianxiety Granule for the treatment of GAD will be evaluated by examining the change in the Hamilton anxiety scale (HAMA) score, state-trait anxiety inventory (STAI) score, and TCM symptom scale in patients with GAD who receive daily TCM treatment. Moreover, an intention-to-treat (ITT) analysis will also be used in this randomized controlled trial (RCT).
Our study is a multicentre, randomized, double-blind, placebo-controlled, parallel-group trial to evaluate the safety and efficacy of Antianxiety Granule for the treatment of GAD. The results of this trial will provide valuable clinical evidence for the treatment of GAD.
Chinese Clinical Trial Registry, ChiCTR1800016039. Registered on 8 May 2018.
焦虑障碍是中国最常见的终身障碍类别，广泛性焦虑障碍（GAD）是最常见但经常被忽视的焦虑障碍之一。传统的 GAD 药物治疗有不同程度的副作用、依赖性和/或戒断症状。中药（TCM）被认为是焦虑障碍的一种有价值的治疗选择，也是减少抗精神病药物相关副作用的潜在有效技术。本试验旨在评估安神颗粒（一种中药复方颗粒）治疗 GAD 的临床疗效和安全性。
方法/设计：本研究为多中心、随机、双盲、安慰剂对照、平行分组临床试验，疗程为 6 周。研究分为三个阶段：1-7 天的筛选期、6 周的主要治疗期和 1 周的随访期。在最后一次就诊后 1 周内，将通过面对面访谈或电话进行随访评估。通过评估 GAD 患者汉密尔顿焦虑量表（HAMA）评分、状态-特质焦虑量表（STAI）评分和 TCM 症状量表的变化，来评估安神颗粒治疗 GAD 的临床疗效。此外，本随机对照试验（RCT）也将采用意向治疗（ITT）分析。
我们的研究是一项多中心、随机、双盲、安慰剂对照、平行分组试验，旨在评估安神颗粒治疗 GAD 的安全性和疗效。该试验的结果将为 GAD 的治疗提供有价值的临床证据。
中国临床试验注册中心，ChiCTR1800016039。注册于 2018 年 5 月 8 日。
