Rheum and Pharyngitis Oral Solution for mild COVID-19 patients with the syndrome of damp-heat accumulation in the lung pattern: A randomized, double-blind, double-dummy, positive drug parallel controlled study
- Conditions
- COVID-19
- Registration Number
- ITMCTR2200005905
- Lead Sponsor
- Guangdong Provincial Hospital of Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
?Patients who meet the diagnostic criteria of mild COVID-19; ?Patients who meet the TCM syndrome of damp-heat accumulation in the lung pattern;?The clinical manifestations are at least one of the four main symptoms including fever, sore throat, cough and fatigue;?Since the onset of COVID-19, the axillary temperature of the patient is = 38.5 ?; ?Patients who are aged 18–75 years; ?Patients who sign the written informed consent form.
?Patients with COPD,asthma,bronchiectasis,active pulmonary tuberculosis,lung malignant tumors or Interstitial lung disease;?Patients with severe cardiovascular, cerebrovascular,severe diseases of hematopoietic systemliver,malignant tumors or those Alanine aminotransferase (ALT), aspartate aminotransferase (AST) or serum creatinine (Scr) exceed 1.5 times the upper limit of normal value; ?Patients who are unwilling to cooperate or unable to cooperate due to neurological and mental diseases;?Patients with history of allergies or hypersensitivity for any research drug component;?Patients with peptic ulcer or digestive hemorrhage;?Pregnant or lactating women, or those planning pregnancy;?Patients who have received any experimental drug treatment within 3 months;?Patients considered unsuitable for inclusion by the researchers.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The cure rate of symptoms including sore throat, fever, cough and fatigue;
- Secondary Outcome Measures
Name Time Method The disappearance time of single symptom including sore throat, fever, cough and fatigue;The change of cough severity VAS scores;The cure rate of different symptoms of sore throat, fever, cough and fatigue;The area under curve(AUC) of sore throat severity VAS scores;The negative rate of virus nucleic acid;The disappearance time of symptoms including sore throat, fever, cough and fatigue;The change of sore throat severity VAS scores;Incidence of common or severe novel coronavirus pneumonia;The re-positive rate of virus nucleic acid;The change of fatigue severity VAS scores;