RCT for Yinqiaosan-Maxingganshitang in the Treatment of COVID-19
ConditionCOVID-19
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorChinese University of Hong Kong
About this trial
This is a randomized, double-blinded, placebo-controlled clinical trial. This study is to evaluate the effectiveness and safety of Yinqiaosan-Maxingganshitang in the treatment of the major symptoms of mild and moderate COVID-19 patients by telemedicine.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age from 18 to 65 years;
Tested positive for COVID-19 by RATs, Deep Throat Saliva (DTS) or Throat/Nasal swab RT-PCR tests;
Patient diagnosed with mild to moderate COVID-19 based on the "Coronavirus disease 2019 (COVID-19) Treatment Guidelines" published by National Institutes of Health;
Duration of symptoms ≤ 72 hours (Start from the presence of the major symptoms of COVID-19: Fever: oral temperature >37.2°C, or cough score ≥2, or fatigue score ≥2);
Disqualifiers
Diagnosed of Asymptomatic or Presymptomatic Infection, Severe Illness or Critical Illness of COVID-19 based on the "Coronavirus disease 2019 (COVID-19) Treatment Guidelines" published by National Institutes of Health
Known allergy to the Chinese medicines or other ingredients of the investigational medicinal products (IMP) used in this study;
Known pregnancy or lactation;
Known immunocompromised patient (such as malignancy, organ or bone marrow transplant, AIDS or low immune function caused by long-term use of corticosteroids or other immunosuppressants)
Trial design
Design model
Parallel
Treatments tested in this trial
Chinese Herb
DrugYinqiaosan-Maxingganshitang granules
Placebo
Diagnostic testPlacebo
Treatment groups
96 Participants
are divided into 2 treatment groupsGroup A: Active treatment (Yinqiaosan-Maxingganshitang )Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Time for the body temperature to change to normal
The time between starting medication and body temperature dropping to normal (oral temperature ≤ 37.2℃ and maintain 24 hours).
Time frame
From baseline to week 19Secondary outcomes
1
Time of negative Rapid Antigen Test
2\. The negative rate of Rapid Antigen Tests (RATs) at day 14 and the negative conversion time (two successive negative RATs result with at least 24 hours interval)
Time frame
From baseline to reaching outcome2
Remission rate of cough
The remission of cough will be measured by the score rating from 0 to 4, which representing "None", "Mild", "Moderate", "Severe" and "Very severe" respectively. The score of 1 or below and maintain for 24 hours will be counted as remission.
Time frame
14 days3
Remission rate of fatigue
The remission of fatigue will be measured by the score rating from 0 to 4, which representing "None", "Mild", "Moderate", "Severe" and "Very severe" respectively. The score of 1 or below and maintain for 24 hours will be counted as remission.
Time frame
14 days4
Time of remission of cough
Time from the start of treatment to the symptom remission
Time frame
From baseline to week 19Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov