[Translation] A randomized, double-blind, parallel-controlled, multicenter clinical trial of the efficacy and safety of Qingfei Xiaoyan Pills (with goat horns instead of antelope horns) in the treatment of acute bronchitis with phlegm-heat obstructing the lungs

（1）评价清肺消炎丸（以山羊角替代羚羊角）治疗急性支气管炎痰热阻肺证的有效性。观察指标：疾病临床痊愈率、中医证候有效率、单项症状消失率、肺部体征消失率等。（2）观察清肺消炎丸（以山羊角替代羚羊角）临床应用的安全性。观察指标：不良事件/不良反应发生率，实验室检查，生命体征等。

[Translation]

(1) To evaluate the effectiveness of Qingfei Xiaoyan Pills (with goat horns instead of antelope horns) in the treatment of acute bronchitis with phlegm-heat obstructing the lungs. Observation indicators: clinical cure rate, TCM syndrome effectiveness rate, disappearance rate of single symptoms, disappearance rate of lung signs, etc. (2) To observe the safety of Qingfei Xiaoyan Pills (with goat horns instead of antelope horns) in clinical application. Observation indicators: incidence of adverse events/adverse reactions, laboratory tests, vital signs, etc.

Start Date22 Mar 2022

Sponsor / Collaborator

Tianjin Pharmaceutical Da Ren Tang Group Corp. Ltd.

CTR20213432 / Active, not recruitingPhase 3

清肺消炎丸（以山羊角替代羚羊角）治疗急性上呼吸道感染痰热阻肺证有效性及安全性的随机、双盲、原处方制剂平行对照、多中心临床试验

1.评价清肺消炎丸（以山羊角替代羚羊角）治疗急性上呼吸道感染痰热阻肺证的有效性。观察指标：疾病临床痊愈率、并发症发生率、单项症状消失率、中医证候疗效。 2.观察清肺消炎丸（以山羊角替代羚羊角）临床应用的安全性。观察指标：不良事件/不良反应发生率、生命体征、实验室检查等。

[Translation]

1. To evaluate the effectiveness of Qingfei Xiaoyan Pills (with goat horns instead of antelope horns) in the treatment of acute upper respiratory tract infection with phlegm-heat obstructing lung syndrome. Observation indicators: clinical cure rate, complication rate, single symptom disappearance rate, TCM syndrome efficacy. 2. To observe the safety of Qingfei Xiaoyan Pills (with goat horns instead of antelope horns) in clinical application. Observation indicators: incidence of adverse events/adverse reactions, vital signs, laboratory tests, etc.

Start Date16 Mar 2022

Sponsor / Collaborator

Tianjin Pharmaceutical Da Ren Tang Group Corp. Ltd.

CTR20213437 / Active, not recruitingPhase 3

清肺消炎丸（以山羊角替代羚羊角）治疗慢性支气管炎急性发作痰热阻肺证有效性及安全性的随机、双盲、原处方制剂平行对照、多中心临床试验

（1）评价清肺消炎丸（以山羊角替代羚羊角）治疗慢性支气管炎急性发作（痰热阻肺证）的有效性。观察指标：疾病临床痊愈率、中医证候有效率、单项症状消失率、肺部体征消失率。（2）观察清肺消炎丸（以山羊角替代羚羊角）临床应用的安全性。观察指标：不良事件/不良反应发生率，生命体征，实验室检查等。

[Translation]

(1) To evaluate the effectiveness of Qingfei Xiaoyan Pills (with goat horns instead of antelope horns) in treating acute exacerbation of chronic bronchitis (phlegm-heat obstructing the lungs syndrome). Observation indicators: clinical cure rate, TCM syndrome efficacy, disappearance rate of single symptom, disappearance rate of lung signs. (2) To observe the safety of Qingfei Xiaoyan Pills (with goat horns instead of antelope horns) in clinical application. Observation indicators: incidence of adverse events/adverse reactions, vital signs, laboratory tests, etc.

Start Date01 Mar 2022

Sponsor / Collaborator

Tianjin Pharmaceutical Da Ren Tang Group Corp. Ltd.

100 Clinical Results associated with Qingfei Xiaoyan Pills

100 Translational Medicine associated with Qingfei Xiaoyan Pills

100 Patents (Medical) associated with Qingfei Xiaoyan Pills

Literatures (Medical) associated with Qingfei Xiaoyan Pills

01 Nov 2024·Journal of Ethnopharmacology

Jianwei Xiaoyan granule ameliorates chronic atrophic gastritis by regulating HIF-1α-VEGF pathway

Article

Author: Liu, Jia ; Li, Fang ; Yang, Junhui ; Li, Mengyu ; Jiang, Ying ; Chen, Guobao ; Hua, Haibing

ETHNOPHARMACOLOGICAL RELEVANCEJianwei Xiaoyan Granule (JWXYG) is the traditional Chinese medicine preparation in Jiangyin Hospital Affiliated to Nanjing University of Chinese Medicine, which has been widely used in clinical treatment of chronic atrophic gastritis (CAG). However, the material basis and potential mechanism of JWXYG in the treatment of CAG are not clear.PURPOSETo explore the material basis and potential mechanism of JWXYG in the treatment of CAG.METHODSIn this study, the components of JWXYG were analyzed by HPLC-Q-TOF-MS/MS. Then, the CAG model in rats established by a composite modeling method and MC cell model induced by MNNG were used to explore the improvement effect of JWXYG on CAG. Finally, the potential mechanism of JWXYG in the treatment of CAG was preliminarily predicted based on network pharmacology and validated experimentally.RESULTSThirty-one components of JWXYG were analyzed through HPLC-Q-TOF-MS/MS, such as albiflorin, paeoniflorin, lobetyolin firstly. Research results in vivo showed that the gastric mucosa became thinner, intestinal metaplasia appeared, the number of glands was reduced, the serum levels of PG I and PG II increased and the contents of G17 and IL-6 reduced in CAG model rats. After 4 weeks of JWXYG (2.70 g/kg) administration, these conditions were significantly improved. In addition, cell viability, migration, and invasion of MNNG-induced MC cells was inhibited by JWXYG treatment (800 μg/mL). Furthermore, the results of network pharmacology indicated that HIF-1 and VEGF signaling pathways might play important roles in the therapeutic process. Then the results of Western blot, immunohistochemistry and immunofluorescence confirmed that with JWXYG treatment, the increased expression of HIF-1α, VEGF and VEGFR2 in gastric issue of CAG rats were restrained. Eventually, potential components of JWXYG in the treatment of CAG were predicted through molecular docking to elucidate the material basis.CONCLUSIONJWXYG could inhibit angiogenesis by regulating HIF-1α-VEGF pathway to exert therapeutic effects on CAG. Our study explored the potential mechanisms and material basis of JWXYG in the treatment of CAG and provides experimental data for the clinical rational application of JWXYG.

01 Jun 2024·Journal of Cellular and Molecular Medicine

Study of the mechanism by which Xiaoyan decoction combined with E7449 regulates tumorigenesis in lung adenocarcinoma

Article

Author: Gu, Lili ; Zheng, Xu ; Han, Yanyan ; Gao, Shan ; Li, Chong ; Lv, Yan

AbstractTNKS is a new target for the treatment of lung adenocarcinoma, the synergistic effects of the TCM compound Xiaoyan decoction and the TNKS inhibitor E7449 in the intervention on TNKS were investigated, and the possible underlying mechanisms involved were clarified. Immunohistochemistry was used to analyse TNKS expression in tumour tissues. The impact of targeting TNKS on cell growth, invasion, apoptosis, key genes and signalling pathways was investigated in tumour cells by Western blotting, rescue experiments, colony formation assays, flow cytometry and label‐free experiments. Tumour xenografts with A549 cells were then transplanted for in vivo study. We found that TNKS high expression was closely related to the advanced tumour stage and tumour size in lung adenocarcinom. After TNKS was knocked down in vitro, the growth, proliferation, migration and invasion were markedly reduced in A549 and H1975 cells. We subsequently applied the Xiaoyan decoction and TNKS inhibitors to intervene in lung adenocarcinoma. Xiaoyan decoction and E7449 suppressed TNKS expression and inhibited adenocarcinoma cell proliferation, migration, invasion and apoptosis in vitro. Proteomic analysis revealed that E7449 treatment may be most closely associated with the classic Wnt/β‐catenin pathway, whereas Xiaoyan decoction treatment may be related to the WNT/PLAN pathway. Xenograft studies confirmed that E7449 or Xiaoyan decoction inhibited lung tumour growth in vivo and attenuated the Wnt signalling pathway in adenocarcinoma. These findings suggest that TNKS is a novel therapeutic target. TCM preparations and small molecule inhibitors are expected to constitute an effective combination strategy.

01 Oct 2023·Pharmacological research

Guideline on treating community-acquired pneumonia with Chinese patent medicines.

Article

Author: Lin, Jiangtao ; Wang, Minghang ; Bai, Gang ; Sun, Zengtao ; Liu, Huiguo ; Yu, Jiajie ; Wen, Fuqiang ; Li, Suyun ; Chen, Yaolong ; Yang, Jiang ; Wang, Jianxin ; Xie, Yang ; Li, Jiansheng

Community-acquired pneumonia (CAP) is one of the most common infectious diseases, and its morbidity and mortality increase with age. Resistance and mutations development make the use of anti-infective therapy challenging. Chinese patent medicines (CPMs) are often used to treat CAP in China and well tolerable. However, currently there are no evidence-based guideline for the treatment of CAP with CPMs, and the misuse of CPMs is common. Therefore, we established a guideline panel to develop this guideline. We identified six clinical questions through two rounds of survey, and we then systematically searched relevant evidence and performed meta-analyses, evidence summaries and GRADE decision tables to draft recommendations, which were then voted on by a consensus panel using the Delphi method. Finally, we developed ten recommendations based on evidence synthesis and expert consensus. For the treatment of severe CAP in adults, we recommend Tanreqing injection, Reduning injection, Xuebijing injection, Shenfu injection, and Shenmai injection respectively. For the treatment of non-severe CAP in adults, we recommend Tanreqing injection, Reduning injection, Lianhua Qingwen capsule/granule, Qingfei Xiaoyan Pill and Shufeng Jiedu capsule respectively. CPMs have great potential to help in the fight against CAP worldwide, but more high-quality studies are still needed to strengthen the evidence.

100 Deals associated with Qingfei Xiaoyan Pills

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Cough	CN	Tianjin Darentang No. 2 Pharmaceutical Factory Co. Ltd.	24 Apr 2020

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Acute Bronchitis	Phase 3	CN	Tianjin Pharmaceutical Da Ren Tang Group Corp. Ltd.	22 Mar 2022
Acute upper respiratory infection	Phase 3	CN	Tianjin Pharmaceutical Da Ren Tang Group Corp. Ltd.	16 Mar 2022
Bronchitis, Chronic	Phase 3	CN	Tianjin Pharmaceutical Da Ren Tang Group Corp. Ltd.	01 Mar 2022

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