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.
Subjects who are diagnosed with COVID-19 by RATs or PCR tests and fulfilled the eligibility criteria will receive a maximum of 14 days of treatment with Yinqiaosan-Maxingganshitang (with or without specified additions) or placebo and will be followed up on day 7, 14 and 35 after receiving medication (day 0).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
96
Yinqiaosan-Maxingganshitang granules
Placebo
Hong Kong Institute of Integrative Medicine
Hong Kong, Hong Kong
RECRUITINGTime 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 19
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 outcome
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 days
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 days
Time of remission of cough
Time from the start of treatment to the symptom remission
Time frame: From baseline to week 19
Time of remission of fatigue
Time from the start of treatment to the symptom remission
Time frame: From baseline to week 19
Disappearance rate of COVID symptom
The disappearance rate of the COVID symptom
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Time frame: 14 days
Incidence to severe illness
Incidence of the progression to severe ot critical illness during the trial
Time frame: From baseline to 19 weeks
Mortality
All-cause mortality at the 21th days after stopping the medications
Time frame: 21 days
Utilization rate of rescue drugs
Utilization rate of antipyretic, Paxlovid and molnupiravir within 14 days
Time frame: 14 days
Dosage of rescue drugs
Dosage of antipyretic, Paxlovid and molnupiravir within 14 days
Time frame: 14 days