Abstract
Abstract
Background: 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) therapy 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 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- to 7-day screening period, a 6-week primary treatment period, and a 1-week follow-up period. Follow-up assessments will be conducted one 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 GAD patients who receive the daily TCM treatment. Moreover, an intention-to-treat (ITT) analysis will also be used in this randomized controlled trial (RCT).
Discussion: 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.
Trial registration: The trial was registered with Chinese Clinical Trial Registry (http://www.chictr.org.cn/showproj.aspx?proj=27210) under the registration number ChiCTR1800016039 on 8 May 2018. The study was approved by the Ethics Committee of the Shanghai Municipal Hospital of Traditional Chinese Medicine (2017SHL-KY-14).
Keywords: Generalized anxiety disorder (GAD), Traditional Chinese Medicine (TCM), RCT, Efficacy, Safety
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