[Translation] A multicenter phase IV clinical trial on the safety and efficacy of Shaoma Zhijing Granules in the treatment of tic disorders in children

评价芍麻止痉颗粒治疗儿童抽动障碍的安全性和有效性。具体包括： (1) 观察芍麻止痉颗粒对不同儿童抽动障碍分型：Tourette综合征、慢性抽动障碍的安全性和有效性； (2) 观察芍麻止痉颗粒对中医肝亢风动、痰火内扰证儿童抽动障碍的安全性和有效性。

[Translation]

To evaluate the safety and efficacy of Shao Ma Zhi Jing Granules in the treatment of tic disorders in children. Specifically, the following are included: (1) To observe the safety and efficacy of Shao Ma Zhi Jing Granules in the treatment of different types of tic disorders in children: Tourette syndrome and chronic tic disorder; (2) To observe the safety and efficacy of Shao Ma Zhi Jing Granules in the treatment of tic disorders in children with liver hyperactivity and wind movement and phlegm-fire internal disturbance syndrome in traditional Chinese medicine.

Start Date12 Feb 2022

Sponsor / Collaborator

Tasly Pharmaceutical Group Co., Ltd.

100 Clinical Results associated with Shaoma Zhijing Granules

100 Translational Medicine associated with Shaoma Zhijing Granules

100 Patents (Medical) associated with Shaoma Zhijing Granules

Literatures (Medical) associated with Shaoma Zhijing Granules

01 Aug 2024·Zhongguo Zhong yao za zhi = Zhongguo zhongyao zazhi = China journal of Chinese materia medica

[Pharmacoeconomic evaluation of Shaoma Zhijing Granules in treatment of tic disorders in children].

Article

Author: Zhang, Yu-Xuan ; Wang, Yong-Yan ; Wu, Xue ; Liao, Xing ; Wan, Chu-Chuan

This study conducted a pharmacoeconomic evaluation of Shaoma Zhijing Granules in the treatment of tic disorder(TD) in children. Firstly, from the perspective of the healthcare system, cost-effectiveness analysis was used to evaluate the economic efficiency of Shaoma Zhijing Granules compared with Changma Xifeng Tablets and Jiuwei Xifeng Granules in the treatment of TD in children. Then, through network Meta-analysis, the overall effectiveness of different regimens was calculated, combined with the total cost of the regimens, to calculate the incremental cost-effectiveness ratio(ICER). Finally, sensitivity analysis was performed to verify the stability of the study results and the credibility of the conclusions. This study included 17 articles, including 9 articles on Chinese patent medicines(3 on Shaoma Zhijing Granules, 2 on Jiuwei Xifeng Granules, and 4 on Changma Xifeng Tablets), for the treatment of TD in children, and 8 articles on Chinese patent medicines combined with conventional western medicines(3 on Shaoma Zhijing Granules, 2 on Jiuwei Xifeng Granules, and 3 on Changma Xifeng Tablets). In the Chinese patent medicine group, the total cost of Shaoma Zhijing Granules for treating TD was CNY 4 410.00, with clinical total effective rate of 77.53%; the total cost of Jiuwei Xifeng Granules for treating TD was CNY 5 192.70, with clinical total effective rate of 82.13%. The ICER of Jiuwei Xifeng Granules vs Shaoma Zhijing Granules was 169.95, higher than the willingness-to-pay(WTP, cost of increasing efficiency by 1% is CNY 85.70). Therefore, Jiuwei Xifeng Granules did not have a cost-effectiveness advantage over Shaoma Zhijing Granules. The total cost of Changma Xifeng Tablets for treating TD was CNY 1 282.50, with clinical total effective rate of 80.60%. The total cost of Changma Xifeng Tablets was lower and clinical total effective rate was higher than that of Shaoma Zhijing Granules. Overall, Shaoma Zhijing Granules did not have a cost-effectiveness advantage. In the Chinese patent medicine combined with conventional western medicine group, the total cost of Shaoma Zhijing Granules for treating TD + conventional western medicines was CNY 6 768.52/6 778.48, with clinical total effective rate of 96.18%. The total cost of Jiuwei Xifeng Granules + conventional western medicines for treating TD was CNY 6 522.56, with clinical total effective rate of 88.30%. The ICER of Shaoma Zhijing Granules + conventional western medicines vs Jiuwei Xifeng Granules + conventional western medicines was 31.20, lower than WTP. Therefore, Shaoma Zhijing Granules + conventional western medicines had a cost-effectiveness advantage over Jiuwei Xifeng Granules + conventional western medicines. The total cost of Changma Xifeng Tablets + conventional western medicines for treating TD was CNY 1 706.12, with clinical total effective rate of 95.39%. The ICER of Shaoma Zhijing Granules + conventional western medicines vs Changma Xifeng Tablets + conventional western medicines was 6 334.06, higher than WTP. Therefore, although Shaoma Zhijing Granules + conventional western medicines had higher clinical total effective rate compared with Changma Xifeng Tablets + conventional western medicines, it did not have a cost-effectiveness advantage. Overall, for different medication regimens(Chinese patent medicines monotherapy or in combination with conventional western medicines), Shaoma Zhijing Granules and Jiuwei Xifeng Granules both had a cost-effectiveness advantage, but compared with Changma Xifeng Tablets, neither had a cost-effectiveness advantage. For Chinese patent medicines in combination with conventional western medicines, clinical total effective rate of Shaoma Zhijing Granules in combination with conventional western medicines for the treatment of TD in children was the highest.

01 Jul 2024·Phytomedicine

The effects of Shaoma Zhijing granules and its main components on Tourette syndrome

Review

Author: Hu, Yunhui ; Chen, Yibing ; Su, Xuefeng ; Bloch, Michael H ; Yan, Yiman ; Yu, Jie ; Song, Xujiao ; Zhou, Shuiping ; Leckman, James F ; Zhao, Qian ; Sun, He ; Wang, Wenjia

BACKGROUNDTourette syndrome (TS) represents a neurodevelopmental disorder characterized by an uncertain etiology and influencing factors. Frequently, it co-occurs with conditions such as attention deficit hyperactivity disorder, obsessive-compulsive disorder, and sleep disturbances, which have garnered substantial attention from the research community in recent years. Clinical trials have demonstrated that Shaoma Zhijing Granules (SMZJG, 5-ling granule, also known as TSupport or T92 under U.S. development), a traditional Chinese medicine compound, is an effective treatment for TS.PURPOSETo conduct scientometric analysis on developing trends, research countries and institutions, current status, hot spots of TS and discuss the underlying mechanisms of SMZJG and its main components on TS. The aim is to provide valuable reference for ongoing clinical and basic research on TS and SMZJG.STUDY DESIGN & METHODSUsing Tourette syndrome, SMZJG and its main components along with their synonyms as keywords, we conducted a comprehensive search across major scientific databases including the Web of Science Core Collection, PubMed and China National Knowledge Infrastructure (CNKI) databases. A total of 5952 references and 99 patents were obtained. Among these, 5039 articles and reviews, as well as 54 patents were analyzed by Citespace and VOSviewer software.RESULTSThe available evidence indicates that the SMZJG's components likely exert their mechanisms in treating TS by regulating the dopaminergic pathway system, neurotransmitter imbalances, reducing neuroinflammation, promoting the repair of nerve damage and improving sleep disorders.CONCLUSIONThis comprehensive analysis lays the foundation for an extensive exploration of the feasibility and clinical applications of SMZJG in TS treatment.

01 Jul 2023·Zhongguo Zhong yao za zhi = Zhongguo zhongyao zazhi = China journal of Chinese materia medica

[Three oral Chinese patent medicines for children with tic disorder: a rapid health technology assessment].

Article

Author: Liao, Xing ; Wu, Xue ; Wang, Zhong ; Wang, Yong-Yan

This study aims to comprehensively evaluate the clinical value of Shaoma Zhijing Granules(SZG), Changma Xifeng Tablets(CXT), and Jiuwei Xifeng Granules(JXG) in the treatment of children with tic disorder with the method of rapid health technology assessment(RHTA), which is expected to serve as a reference for medical and health decision-making and clinical rational use of drugs in children. To be specific, relevant articles were retrieved from eight databases and three clinical trial registry platforms. After the quality evaluation, rapid assessment was carried out from the dimensions of disease burden and unmet needs, technical characteristics, safety, efficacy and economy, and the results were analyzed and presented descriptively. A total of 22 articles(1 in English, 21 in Chinese) were screened out: 18 randomized controlled trials(RCTs) and 4 clinical controlled trials(CCTs). Among them, 5 were about the SZG(all RCTs) and 9 were on CXT(6 RCTs and 3 CCTs). The rest 8 focused on JXG(7 RCTs and 1 CCT). Moreover, the overall risk of bias for 94.40% RCTs was evaluated as "some concerns" and only one(5.60%) had high risk of bias. In terms of quality, the 4 CCTs scored 5-6 points(<7 points), suggesting low quality. SZG alone or in combination with tiapride has obvious advantages in improving traditional Chinese medicine syndromes and tic symptoms compared with tiapride alone, with the average daily cost of CNY 79.44-119.16. Compared with conventional western medicine or placebo, CXT alone or in combination with conventional western medicine can improve the total effective rate and alleviate tic symptoms, and the average daily cost is CNY 22.50-67.50. JXG alone or in combination with conventional western medicine can effectively relieve tic symptoms compared with conventio-nal western medicine or placebo, with the average daily cost of CNY 82.42-164.85. The adverse events related to the three Chinese patent medicines mainly occurred in the digestive, respiratory, and nervous systems, all of which were mild. In general, SZG, CXT, and JXG are effective for children with tic disorder. They have been approved to be used in this field, of which SZG was approved in 2019, with the most up-to-date research evidence and high-quality RCT in Q1 journals. However, the comparative analysis of the three was affected by many factors, which should be further clarified. Based on the large sample data available in multiple dimensions, a comprehensive comparative evaluation of the three Chinese patent medicines should be carried out, thereby highlighting the advantages and disadvantages of them and serving a reference for rational clinical use and drug supervision.

100 Deals associated with Shaoma Zhijing Granules

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Indication	Country/Location	Organization	Date
Tourette Syndrome	CN	Tasly Pharmaceutical Group Co., Ltd.	18 Dec 2019

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