[Translation] A randomized, double-blind, placebo-controlled, multicenter phase III clinical trial on the efficacy and safety of Suxin Tongqiao granules in the treatment of persistent allergic rhinitis (wind evil invading the lung syndrome)

评价苏辛通窍颗粒治疗持续性变应性鼻炎（风邪犯肺证）的有效性及安全性。

[Translation]

To evaluate the efficacy and safety of Suxin Tongqiao Granules in the treatment of persistent allergic rhinitis (wind evil invading the lung syndrome).

Start Date20 Nov 2023

Sponsor / Collaborator

Jiangsu Kanion Pharmaceutical Co., Ltd.

CTR20230828 / CompletedPhase 2

苏辛通窍颗粒治疗持续性变应性鼻炎（风邪犯肺证）有效性和安全性的多中心、随机、双盲、安慰剂对照Ⅱb期临床试验试验

[Translation] A multicenter, randomized, double-blind, placebo-controlled phase IIb clinical trial on the efficacy and safety of Suxin Tongqiao granules in the treatment of persistent allergic rhinitis (wind evil attacking the lung syndrome)

评价苏辛通窍颗粒治疗持续性变应性鼻炎（风邪犯肺证）的有效性及安全性

[Translation]

To evaluate the efficacy and safety of Suxin Tongqiao granules in the treatment of persistent allergic rhinitis (wind evil invading the lung syndrome)

Start Date06 Apr 2023

Sponsor / Collaborator

Jiangsu Kanion Pharmaceutical Co., Ltd.

CTR20213261 / RecruitingPhase 3

紫辛鼻鼽颗粒改善持续性变应性鼻炎临床症状的有效性及安全性、随机、双盲双模拟、阳性药/安慰剂对照、III期临床试验

[Translation] The efficacy and safety of Zixinbiyu granules in improving the clinical symptoms of persistent allergic rhinitis: a randomized, double-blind, double-dummy, active drug/placebo-controlled, phase III clinical trial

主要目的：（1）评价紫辛鼻鼽颗粒对于持续性变应性鼻炎患者的临床症状的改善作用。（2）评价紫辛鼻鼽颗粒的药物安全性。次要目的：（1）观察紫辛鼻鼽颗粒对于持续性变应性鼻炎患者中医证候的改善作用。

[Translation]

Main objectives: (1) To evaluate the effect of Zixinbiyu Granules on the improvement of clinical symptoms in patients with persistent allergic rhinitis. (2) To evaluate the drug safety of Zixinbiyu Granules. Secondary objectives: (1) To observe the effect of Zixinbiyu Granules on the improvement of TCM syndromes in patients with persistent allergic rhinitis.

Start Date16 Feb 2022

Sponsor / Collaborator

Jiangsu Kanion Pharmaceutical Co., Ltd.

100 Clinical Results associated with Zixin Biqiu Granules

100 Translational Medicine associated with Zixin Biqiu Granules

100 Patents (Medical) associated with Zixin Biqiu Granules

Literatures (Medical) associated with Zixin Biqiu Granules

01 Oct 2022·Zhongguo Zhong yao za zhi = Zhongguo zhongyao zazhi = China journal of Chinese materia medica

[Mechanism of Zixin Biqiu Granules in treatment of allergic rhinitis based on network pharmacology and molecular docking technology].

Article

Author: Ming, Yu ; Yuan, An-Lei ; Zhang, Xin-Yi ; Shu, Xin-Yang

Allergic rhinitis(AR) is a chronic inflammatory disorder of nasal mucosa induced by allergen exposure triggering IgE-mediated inflammation. With frequent recurrence, it is difficult to be cured. Zixin Biqiu Granules is developed based on the 60-year clinical experience of CHAO En-xiang, a master of national medicine of China-Japan Friendship Hospital. At present, phase Ⅲ multicenter clinical trial is being prepared, but the mechanism is unclear. Therefore, this study explored the mechanism of Zixin Biqiu Granules against AR based on network pharmacology and molecular docking. First, the chemical components and targets of Zixin Biqiu Granules were retrieved from Traditional Chinese Medicine Systems Pharmacology Database and Analysis Platform(TCMSP), and the targets of AR from GeneCards and Online Mendelian Inheritance in Man(OMIM). Then the common targets of the two were screened out and the "Chinese medicine-component-target" network was constructed. Afterward, the common targets were imported into the STRING to obtain the interaction of them, and Cytoscape was employed to establish the protein-protein interaction(PPI) network. Through topological analysis, the core targets were obtained. DAVID was used for Gene Ontology(GO) term enrichment and Kyoto Encyclopedia of Genes and Genomes(KEGG) pathway enrichment. The "key target-pathway-biological process" network was constructed to explore the anti-AR mechanism of Zixin Biqiu Granules. Finally, the core targets were selected for molecular docking with the key components of Zixin Biqiu Granules to verify the mechanism. The results showed that there were 151 components and 97 targets in the "Chinese medicine-component-target" network. We obtained 20 core targets, 488 biological processes and 147 pathways in topological, GO, and KEGG enrichment analysis of the protein interaction network, and in the comprehensive analysis, it was found that Zixin Biqiu Granules mainly exerted the therapeutic effect through anti-inflammation and immunoregulation. Serine/threonine-protein kinase 1(AKT1) and tumor necrosis factor(TNF) were docked with the key components of Zixin Biqiu Granules, and the results showed that the key components of Zixin Biqiu Granules had high binding affinity to the core targets. This study preliminarily discussed the anti-AR mechanism of Zixin Biqiu Granules, which laid a scientific basis for its clinical application.

100 Deals associated with Zixin Biqiu Granules

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Indication	Highest Phase	Country/Location	Organization	Date
Rhinitis, Allergic, Perennial	Phase 3	CN	Jiangsu Kanion Pharmaceutical Co., Ltd.	16 Feb 2022

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