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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

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

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20211022002
Enrollment
736
Registered
2021-10-22
Start date
2021-10-28
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

asymptomatic or mild COVID-19 without pneumonia SAR-CoV-2

Interventions

Andrographis capsule equivalent to andrographolide 20 mg/capsule. Total andrographolide 180 mg/ day. Take 3 capsules after three meals for 5 days. ,Placebo contains corn starch identical as Andrograph
Active Comparator Drug,Placebo Comparator Drug
Andrographis capsules,Placebo

Sponsors

Health Systems Research Institute
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
Pneumonia 10 days Chest X-ray

Secondary

MeasureTime frame
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

Countries

Thailand

Contacts

Public ContactPakakrong Kwankhao

Chao Phya Abahibhubejhr hospital

pakakrong2@gmail.com037211289

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026