Status:
SUSPENDED
Yinhu Qingwen Decoction for the Treatment of Mild / Common CoVID-19
Lead Sponsor:
China Academy of Chinese Medical Sciences
Conditions:
CoVID-19
Chinese Medicine
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief 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 ma...
Detailed 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 ma...
Eligibility Criteria
Inclusion
- Age ≥18 years at time of signing Informed Consent Form.
- Laboratory (RT-PCR) confirmed infection with CoVID-19.
- Hospitalised with Fever(≥36.7℃ -axilla or oral temperature ≥ 38.0 ℃ or ≥38.6°C tympanic or rectal) and cough;
- No difficulty swallowing oral medications.
- Must agree not to enroll in another study of an investigational agent prior to completion of Day 28 of study.
Exclusion
- Allergies, known to be allergic to research drugs or drug excipients;
- Patient weight is less than 40 kg;
- Respiratory distress-RR≥30 / min on room air,or SPO2≤ 93%, or PaO2/FiO2 ≤300mmHg (1mmHg = 0.133kPa)
- Shock;
- The clinician judges that ICU monitoring treatment is needed;
- Patients who have participated in other clinical trials within 1 month;
- Known patients with impaired renal function (estimated creatinine clearance \<60 mL / min (male: Cr (ml / min) = (140-age) × body weight (kg) / 72 × blood creatinine concentration (mg / dl); female: Cr (ml / min) = (140-age) × weight (kg) / 85 × blood creatinine concentration (mg / dl));
- During the screening or within 24 hours before screening, patients were found to have any of the following laboratory parameter abnormalities (based on local laboratory reference 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;
- Being pregnant or breastfeeding, or having a positive pregnancy test at the time of pre-dose inspection, or planning to become pregnant within 3 months of study treatment.
Key Trial Info
Start Date :
October 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2023
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT04278963
Start Date
October 1 2021
End Date
May 1 2023
Last Update
July 7 2021
Active Locations (3)
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1
Jingzhou Hospital of Traditional Chinese Medicine
Jingzhou, Hubei, China, 434000
2
Wuhan Leishenshan (Thunder God Mountain) Hospital/The First Affiliated Hospital of Dalian Medical University
Wuhan, Hubei, China, 430200
3
Xiangyang Hospital of Traditional Chinese Medicine
Xiangyang, Hubei, China, 441000