Yinhu Qingwen Granula for the Treatment of Severe CoVID-19

Summary

In December 2019, Wuhan, in Hubei province, China, became the center of an outbreak of pneumonia caused by CoVID-19, and the number of cases of infection with CoVID-19 identified in Wuhan increased markedly over the later part of January 2020, with cases identified in multiple other Provinces of China and internationally.Given no specific antiviral therapy for CoVID-19 infection and the availability of Yinhu Qingwen Granula as a potential antiviral Chinese medicine based on vivo antiviral studies in CoVID-19, this adaptive, randomized,double-blind,controlled trial will evaluate the efficacy and safety of Yinhu Qingwen Granula in patients hospitalized with severe CoVID-19.

Conditions

• COVID-19
• Severe Pneumonia
• Chinese Medicine

Interventions

DRUG

Yinhu Qingwen Granula

Yinhu Qingwen Granula is a kind of herbal granula made from "Yinhu Qingwen Decoction", which consits of 11 Chinese herbal medicine as Honeysuckle, Polygonum cuspidatum, Schizonepeta, Longspur epimedium, etc. The granula will be dissolved into 600ml decoction and divided to 3 times (once with 200ml). It will be given a 200ml per time, three times a day, for 10 days.

DRUG

Yin Hu Qing Wen Granula(low does)

This intervention is given as 10% dose of YinHu QingWen Granula.The granula will be dissolved into 600ml decoction and divided to 3 times (once with 200ml).

OTHER

standard medical treatment

Standard medical treatment is adhered to the protocol of the treatment for the severe CoVID-19 according to the guideline approved by National Health Commission of China.

Sponsors & Collaborators

• Wuhan Leishenshan Hospital

  collaborator UNKNOWN

• The First Affiliated Hospital of Dalian Medical University

  collaborator OTHER

• Tanshan People's Hospital

  collaborator UNKNOWN

• North China University of Science and Technology

  collaborator OTHER

• Jizhong Energy Fengfeng Group Hospital

  collaborator UNKNOWN

• Zhong Wang

  lead OTHER

Principal Investigators

• Dong Shang, M.D. · Wuhan Leishenshan (Thunder God Mountain) Hospital/The First Affiliated Hospital of Dalian Medical University

• Jiang-Rong Huang, M.D. · Yangtze University Health Science Center

• Xiao-Dong Li, M.D. · Hubei Hospital of Traditional Chinese Medicine

• Zhong Wang, M.D. · China Academy of Chinese Medical Sciences

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-11-30

Primary Completion

2022-12-31

Completion

2023-04-30

Countries

• China

Study Locations