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Efficacy and safety of Phillyrin(KD-1)capsule in the treatment of moderate COVID-19:protocol for a randomized controlled trial

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TMR Modern Herbal Medicine 2022年第1期5卷 48-59页

作者： Yang-Qing Zhan Rui-Feng Chen Qin-Hai Ma Jin-Ping Zheng Xi-Long Deng Wei Yang Li Fu Nan-Shan Zhong Zi-Feng Yang National clinical Research Center for Respiratory Disease Guangzhou Institute of Respiratory HealthFirst Affiliated Hospital of Guangzhou Medical UniversityState Key Laboratory of Respiratory Disease(Guangzhou Medical University)Guangzhou510230China Faculty of Chinese Medicine Macao University of Science and TechnologyMacao9998078China Guangzhou Eighth People’s Hospital Guangzhou510060China Guangdong Lewwin Pharmaceutical research institute Co. LtdGuangzhou510990China Jilin Yatai Chinese Medicine Development Institute Changchun130000JilinChina

Objective Phillyrin(KD-1)is a traditional Chinese monomer and the main active component in Lianhua *** present,sufficient studies have confirmed that KD-1 has significant anti-SARS-CoV-2 activity and antiinflammatory effects in vitro and in ***,evidence-based studies to evaluate its therapeutic effect on COVID-19 are ***,we designed a clinical trial to evaluate the efficacy and safety of KD-1 in the treatment of moderate COVID-19 *** This is a multicenter,randomized,double-blind,placebo-controlled clinical trial.A total of 120 participants will be recruited and randomized to receive KD-1 capsule or placebo treatment for 14 days,50 mg per capsule,four capsules each time,three times a *** the SARS-CoV-2 nucleic acid test results are negative twice within 14 days,the KD-1 capsule will be stopped the following ***,patient compliance,and adverse reactions will be recorded,and nucleic acid testing will be conducted *** and secondary outcomes,as well as safety indicators,will be used to evaluate the efficacy and safety of the KD-1 capsule in the treatment of *** Herein,we describe the first clinical trial in China to treat COVID-19 using a traditional Chinese medicine monomer.A randomized,double-blind,placebo-controlled clinical trial is the best way to evaluate the efficacy and safety of KD-1 against moderate COVID-19 *** a good clinical benefit is observed,this represents the first step toward the use of KD-1 capsules to treat *** clinical trial can serve as a model for other evidence-based research of traditional herbal *** registration This study is registered at ***,with registration number:CTR20211800.

关键词： Phillyrin capsule COVID-19 Pneumonia evidence-based clinical trial

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