Efficacy and safety of an Andrographis capsule compared with standard therapy for the treatment of asymptomatic or mild COVID-19 without pneumonia : A double-blinded randomized-control trial
- Conditions
- asymptomatic or mild COVID-19 without pneumoniaSAR-CoV-2
- Registration Number
- TCTR20211022002
- Lead Sponsor
- Health Systems Research Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 736
1. Age 18-60 years old
2. Have been diagnosed as a new case by RT-PCR within 72 hours
3. Have no symptoms or mild symptoms which do not need medication such as low grade fever (body temperature less than 38 degree celcius) cough, runny nose, sore throat, body aches, headache, loss of taste, loss of smell
4. Have resting oxygen Saturation not less than 96% and SpO2 changes after performing exercise-induced desaturation less than 3%
5. Have respiratory rate not over 20 breaths per minute
6. Have normal chest x-ray
7. Have no underlying diseases or under control for more than 6 months
8. Willing to participate in the study
1. Have history of AP allergy
2. Receive antiviral, antibiotic, chloroquine, hydroxychloroquine, ivermectin, interferon within 7 days prior to admission
3. Receive AP or other herbal medicines for COVID-19 treatment within 7 days prior to admission
4. Receive immunosuppressant agents within 6 months prior to admission
5. Receive anticoagulant agents, statins, amlodipine, clozapine, phenytoin
6. Are pregnant or lactating women
7. Have risk factors for COVID-19 progression such as Chronic Obstructive Pulmonary Disease, Chronic Kidney Disease, Cardiovascular Diseases, congenital heart diseases, cerebrovascular disease, uncontrolled diabetes, obesity (BMI greater than 30kg/m2), liver cirrhosis, weakened immune system, cancer and lymphocyte less than 1,000 cells/ mm3
8. Have WHO clinical progression scale greater than 3
9. AST or ALT levels greater than 3 times the upper reference limit
10. GFR lower than 30 mL/min/1.73 m2
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pneumonia 10 days Chest X-ray
- Secondary Outcome Measures
Name Time Method Inflammatory marker 10 days C-reactive protien,Viral load in first 126 patients 10 days Droplet digital PCR viral load,tolerability of AP 10 days adverse product events, renal and liver function, blood pressure, heart rate, serum potassium,Proteomics and metabolomics 10 days Serum profile