[Translation] A randomized, double-blind, parallel-controlled, phase II clinical trial to evaluate the efficacy and safety of Canghuo Pingwei Granules in the treatment of chronic superficial gastritis (spleen and stomach damp-heat syndrome)

进行苍藿平胃颗粒治疗慢性浅表性胃炎（脾胃湿热证）消化不良症状8周后患者有效性和安全性的Ⅱ期临床研究，为Ⅲ期临床研究提供依据。主要研究目的：采用安慰剂对照，评价苍藿平胃颗粒治疗慢性浅表性胃炎（脾胃湿热证）消化不良症状有效性。次要目的：通过评价两组间不良事件发生率，比较试验组与对照组安全性指标的差异。

[Translation]

A Phase II clinical study was conducted to evaluate the effectiveness and safety of Canghuo Pingwei Granules in treating dyspepsia symptoms of chronic superficial gastritis (spleen and stomach damp-heat syndrome) after 8 weeks, to provide a basis for Phase III clinical studies. Main purpose of the study: To evaluate the effectiveness of Canghuo Pingwei Granules in treating dyspepsia symptoms of chronic superficial gastritis (spleen and stomach damp-heat syndrome) by placebo control. Secondary purpose: To compare the differences in safety indicators between the experimental group and the control group by evaluating the incidence of adverse events between the two groups.

Start Date23 Jun 2020

Sponsor / Collaborator

Hefei Chuangxin Medicine Technology Co., Ltd.

100 Clinical Results associated with Canghuo Pingwei Granules

100 Translational Medicine associated with Canghuo Pingwei Granules

100 Patents (Medical) associated with Canghuo Pingwei Granules

Literatures (Medical) associated with Canghuo Pingwei Granules

01 Dec 2021·Chinese MedicineQ3 · MEDICINE

NMPA-approved traditional Chinese medicine-Pingwei Pill: new indication for colistin recovery against MCR-positive bacteria infection

Q3 · MEDICINE

ArticleOA

Author: Deng, Xuming ; Wang, Jianfeng ; Sheng, Qiushuang ; Hou, Xiaoning ; Li, Li ; Ma, Cunhui ; Zhou, Yonglin ; Du, Runbao ; Xu, Lei ; Shen, Xue

AbstractBackgroundThe wide spread of plasmid-mediated colistin resistance by mobile colistin resistance (MCR) in Enterobacteriaceae severely limits the clinical application of colistin as a last-line drug against bacterial infection. The identification of colistin potentiator from natural plants or their compound preparation as antibiotic adjuncts is a new promising strategy to meet this challenge.MethodsHerein, the synergistic activity, as well as the potential mechanism, of Pingwei pill plus antibiotics against MCR-positive Gram-negative pathogens was examined using checkerboard assay, time-killing curves, combined disk test, western blot assay, and microscope analysis. Additionally, the Salmonella sp. HYM2 infection models of mouse and chick were employed to examine the in vivo efficacy of Pingwei pill in combination with colistin against bacteria infection. Finally, network pharmacology and molecular docking assay were used to predicate other actions of Pingwei pill for Salmonella infection.ResultsOur results revealed that Pingwei Pill synergistically potentiated the antibacterial activity of colistin against MCR-1-positive bacteria by accelerating the damage and permeability of the bacterial outer membrane with an FIC (Fractional Inhibitory Concentration) index less than 0.5. The treatment of Pingwei Pill neither inhibited bacterial growth nor affected MCR production. Notably, Pingwei Pill in combination with colistin significantly prolonged the median survival in mouse and chick models of infection using the Salmonella sp. strain HYM2, decreased bacteria burden and organ index of infected animal, alleviated pathological damage of cecum, which suggest that Pingwei Pill recovered the therapeutic performance of colistin for MCR-1- positive Salmonella infection in mice and the naturally infected host chick. Pharmacological network topological analysis, molecular docking, bacterial adhesion, and invasion pathway verification assays were performed to identify the other molecular mechanisms of Pingwei Pill as a colistin potentiator against Gram-negative bacteria infection.ConclusionTaken together, NMPA (National Medical Products Administration)-approved Pingwei Pill is a promising adjuvant with colistin for MCR-positive bacterial infection with a shortened R&D (research and development) cycle and affordable R&D cost and risk.

100 Deals associated with Canghuo Pingwei Granules

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Indication	Highest Phase	Country/Location	Organization	Date
Chronic superficial gastritis	Phase 2	CN	-	23 Jun 2020

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