Abstract
BackgroundAnxiety 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/designThe 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).DiscussionOur 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 registrationChinese Clinical Trial Registry, ChiCTR1800016039. Registered on 8 May 2018.
Highlights
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
A previous study [1] showed that approximately 3.6% of the global population suffers from an anxiety disorder, and the prevalence of anxiety disorders increased by 14.9% from 2005 to 2015
A previous study reported that, even though the combined lifetime prevalence of Generalized anxiety disorder (GAD) has been estimated at 3.7%, and it is commonly diagnosed in primary care settings, the lifetime prevalence in China is only 1.0% [4]
Summary
In the first nationwide survey of mental disorders in China, it was found that anxiety disorders were the most prevalent class of lifetime disorders (7.6%) [22]. Antianxiety Granule has been widely prescribed for anxiety symptoms in specialist clinics. Antianxiety Granule, which is composed of Cyperi rhizoma, Amomum aurantiacum, Cinnamomi cortex, Curcumae radix, Radix salviae, Gardeniae fructus, licorice, Polygala tenuifolia, Albizia bark, Polygoni multiflori caulis and daylily, has been shown to effectively ameliorate symptoms of anxiety and insomnia in patients with GAD. The trial will be conducted in a clinical outpatient setting with experienced clinicians, and participants will be recruited from the patient base of the other five hospitals involved in the trial The purpose of this multicentre, randomized, double-blind, placebo-controlled, parallelgroup trial is to evaluate the efficacy and safety of Antianxiety Granule compared to a placebo in patients with GAD in Shanghai. This study will confirm the safety and efficacy of the TCM Antianxiety Granule and evaluate if Antianxiety Granule can improve distressing symptoms of anxiety
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