Department of Clinical Trial Center, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, National Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion, No. 88 Changling Street, Xiqing District, Tianjin, 300193, China.
Department of Pediatrics, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, National Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion, No. 88 Changling Street, Xiqing District, Tianjin, 300193, China.
Trials. 2022 Oct 22;23(1):898. doi: 10.1186/s13063-022-06802-y.
Tic disorders (TD) is a neuropsychiatric disease with twitch as the main manifestation in childhood. Jiu-Wei-Xi-Feng granules has been marketed in China for treating children with TD. As Long Gu (Os Draconis) in the composition of this Chinese patent medicine is a rare and expensive medicinal material protected by the Chinese government, therefore, we consider replacing it with Mu Li (Concha Ostreae) that has the same effect and is cheaper. This study is designed to evaluate the clinical equivalence between Jiu-Wei-Xi-Feng granules (Os Draconis replaced by Concha Ostreae) (JWXFD) and Jiu-Wei-Xi-Feng granules (original formula) (JWXFO) in children with TD (consumption of renal yin and liver wind stirring up internally syndrome).
METHODS/DESIGN: This is a multicenter, randomized, double-blind, equivalence trial comparing the efficacy and safety of JWXFD and JWXFO in treating Children with tic disorders (consumption of renal yin and liver wind stirring up internally syndrome). A total of 288 patients will be recruited and randomly assigned to two groups in a 1:1 ratio. The treatment course is 6 weeks, with a 2 weeks follow-up. The primary outcome is the mean change value from baseline to 6th week by the Yale Global Tic Severity Scale total tic score (YGTSS-TTS). Secondary outcomes include total effective rate of tic, Yale Global Tic Severity Scale (YGTSS) scores and its factor scores (the degree of motor tics, phonic tics and social function damage), Clinical Global Impression-Severity scale, and TCM syndrome efficacy.
The design of this study refers to a large number of similar research design points, and asked for opinions of peer experts, and finally reached a consensus. This trial will provide high-quality evidence on the clinical equivalence between JWXFD and JWXFO and provide a basis for the marketing of JWXFD.
ChiCTR2000032312 Registered on 25 April 2020, http://www.chictr.org.cn/showproj.aspx?proj=52630.
抽动障碍（TD）是一种以抽搐为主要表现的儿童神经精神疾病。九味熄风颗粒已在中国上市，用于治疗 TD 患儿。由于该中药制剂的处方中地龙（Os Draconis）为中国政府保护的稀有昂贵药材，因此我们考虑用功效相同且价格更便宜的牡蛎（Concha Ostreae）替代。本研究旨在评估九味熄风颗粒（地龙换用牡蛎）（JWXFD）与九味熄风颗粒（原方）（JWXFO）治疗儿童抽动障碍（肝肾阴虚风动证）的临床等效性。
方法/设计：这是一项多中心、随机、双盲、等效性试验，比较 JWXFD 和 JWXFO 治疗儿童抽动障碍（肝肾阴虚风动证）的疗效和安全性。共招募 288 例患者，按 1:1 比例随机分为两组。疗程为 6 周，随访 2 周。主要结局指标为耶鲁综合抽动严重程度量表总抽动评分（YGTSS-TTS）从基线到第 6 周的平均变化值。次要结局指标包括抽动总有效率、耶鲁综合抽动严重程度量表（YGTSS）评分及其因子评分（运动性抽动、发音性抽动和社会功能损害程度）、临床总体印象-严重程度量表和中医证候疗效。
本研究设计参考了大量类似研究的设计要点，并征求了同行专家的意见，最终达成共识。该试验将为 JWXFD 和 JWXFO 的临床等效性提供高质量证据，为 JWXFD 的上市提供依据。
ChiCTR2000032312 于 2020 年 4 月 25 日注册，网址：http://www.chictr.org.cn/showproj.aspx?proj=52630。
