Yinhu Qingwen Decoction for the Treatment of Mild / Common CoVID-19

Last updated: July 4, 2021
Sponsor: China Academy of Chinese Medical Sciences
Overall Status: Suspended

Phase

2/3

Condition

Covid-19

Treatment

N/A

Clinical Study ID

NCT04278963
YHQW-V3.0
  • Ages > 18
  • All Genders

Study 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 Decoction as a potential antiviral Chinese medicine based on vivo antiviral studies in CoVID-19, this randomized,three-arm controlled, single-blind trial will evaluate the efficacy and safety of Yinhu Qingwen Decoction (Granula) in patients hospitalized with mild or common CoVID-19 respiratory disease.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age ≥18 years at time of signing Informed Consent Form.
  2. Laboratory (RT-PCR) confirmed infection with CoVID-19.
  3. Hospitalised with Fever(≥36.7℃ -axilla or oral temperature ≥ 38.0 ℃ or ≥38.6°Ctympanic or rectal) and cough;
  4. No difficulty swallowing oral medications.
  5. Must agree not to enroll in another study of an investigational agent prior tocompletion of Day 28 of study.

Exclusion

Exclusion Criteria:

  1. Allergies, known to be allergic to research drugs or drug excipients;
  2. Patient weight is less than 40 kg;
  3. Respiratory distress-RR≥30 / min on room air,or SPO2≤ 93%, or PaO2/FiO2 ≤300mmHg (1mmHg = 0.133kPa)
  4. Shock;
  5. The clinician judges that ICU monitoring treatment is needed;
  6. Patients who have participated in other clinical trials within 1 month;
  7. Known patients with impaired renal function (estimated creatinine clearance <60 mL /min (male: Cr (ml / min) = (140-age) × body weight (kg) / 72 × blood creatinineconcentration (mg / dl); female: Cr (ml / min) = (140-age) × weight (kg) / 85 × bloodcreatinine concentration (mg / dl));
  8. During the screening or within 24 hours before screening, patients were found to haveany of the following laboratory parameter abnormalities (based on local laboratoryreference range):-ALT or AST level> 5 times the upper limit of normal range (ULN)or-ALT or AST > 3 times ULN and total bilirubin levels> 2 times ULN;
  9. Being pregnant or breastfeeding, or having a positive pregnancy test at the time ofpre-dose inspection, or planning to become pregnant within 3 months of studytreatment.

Study Design

Total Participants: 300
Study Start date:
October 01, 2021
Estimated Completion Date:
May 31, 2023

Study Description

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.

The clinical spectrum of CoVID-19 infection appears to be wide,including asymptomatic infection, mild upper respiratory disease, severe viral pneumonia with respiratory failure, and even death.However,there is no specific antiviral therapy for CoVID-19 infection, which provides a window of opportunity for testing candidate antiviral therapies. Previous experiences with SARS and MERS-CoV, highlight the need of the early intervention with Chinese medicine, and so as for CoVID-19 infection. The treatment of Chinese medicine for CoVID-19 infection suggested its benefits to improve of clinical outcomes, reduce the risk of disease progression, accelerate recovery, and reduce intensive supportive care and long-term hospitalization.

Yinhu Qingwen Decoction (Granula) consists of 11 common non-toxic traditional Chinese medicine such as Polygonum cuspidatum, Honeysuckle, Nepeta, Ligustrum lucidum. Previous vivo antiviral studies showed its activity for the inbition of CoVID-19. This clinical trial is planned to evaluate the mean clinical recovery time for patients with mild and common CoVID-19 infection as the primary outcome, and to evaluate the effect of the symptoms relief and virus clearance as well as the clinical safety.

Connect with a study center

  • Jingzhou Hospital of Traditional Chinese Medicine

    Jingzhou, Hubei 434000
    China

    Site Not Available

  • Wuhan Leishenshan (Thunder God Mountain) Hospital/The First Affiliated Hospital of Dalian Medical University

    Wuhan, Hubei 430200
    China

    Site Not Available

  • Xiangyang Hospital of Traditional Chinese Medicine

    Xiangyang, Hubei 441000
    China

    Site Not Available

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