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Andrographolide as a medical tool for reduction of hospitalization in mild or asymptomatic COVID-19 patients: a randomized double-blind placebo controlled trial

Andrographolide as a medical tool for reduction of hospitalization in mild or asymptomatic COVID-19 patients: a randomized double-blind placebo controlled trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20210514003
Enrollment
240
Registered
2021-05-14
Start date
2021-06-01
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

Andrographolide for COVID-19 patients with mild or no symptom admitted to hospitel or field hospital. Andrographolide COVID-19 Hospitel Field Hospital

Interventions

- Andrographolide (20 mg) 3 capsules tid for 5 days - Favipiravir-like Placebo (200 mg) 9 capsules bid for 1 day then 4 capsules bid for 4 days,- Andrographolide-like Placebo (20 mg) 3 capsules tid fo
Andrographolide with Favipiravir-like Placebo,Favipiravir with Andrographolide-like Placebo,Andrographolide-like Placebo with Favipiravir-like Placebo

Sponsors

Department of Thai Traditional and Alternative Medicine, Ministry of Public Health
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1) Thai participant aged 18-60 years 2) PCR confirmed COVID-19 patient with normal chest X-ray 3) No silent hypoxia by 1-minute sit to stand test (4% or more oxygen saturation reduction after test compared to before test will be considered presence of silent hypoxia) (Key, 2020) 4) Communicable by Thai language 5) Informed consented for participation

Exclusion criteria

Exclusion criteria: 1) Presence of sign or symptoms of pneumonia 2) Receiving at least one anti-viral therapy including Favipiravir, Remdesivir, Lopinavir, Ritonavir, Interferon (B1a), Chloroquine or hydroxychloroquine 3) History of andrographolide allergy 4) Pregnant or lactating women, or plan for pregnancy 5) Participated in other research related to COVID-19 treatment 6) Received andrographolide within 5 day before participation 7) Current smoker with 10 or more cigarettes per day 8) On anti-hypertensive medication 9) History of heart disease, rheumatic heart disease, or acute poststreptococcal glomerulonephritis 10) On anti-platelet or anti-coagulant medication i.e. clopidogrel, warfarin, aspirin. If participants took only low dose aspirin (not more than 81 mg per day) and no sign and symptom of abnormal coagulation, they will not be excluded. 11) Physician concerns for risk or harm from patient's participation. Risk factor for severe disease progression including, but not limited to a. Chornic obstructive pulmonary disease, active TB, pneumonia, or asthma b. Chronic kidney disease, acute kidney injury, end-stage renal disease c. Cardiovascular disease or congenital heart disease d. Stroke e. Uncontrolled diabetes mellitus f. Obesity (BMI > 35 kg/sq.m) g. Cirrhosis h. Immunocompromised host i. Lymphocyte less than 1,000 cell/m3

Design outcomes

Primary

MeasureTime frame
Hospitalization rate during 14 days (if any) Medical record

Secondary

MeasureTime frame
Duration before hospitalization during 14 days (if any) Medical record,COVID-19 symptoms baseline, once per day for 14 days Patient report,Adverse event during 14 days (if any) Patient report,Silent hypoxia baseline, once per day for 14 days 1 minute sit to stand test,Chest X-ray only when silent hypoxia present Clinical diagnosis,Vital signs baseline/ 5 minute intervals during 14 days (if available) manual/automated by smart wristband (if available),Electrocardiogram baseline and 5 minute intervals during 14 days (if available) automated by smart wristband (if available)

Countries

Thailand

Contacts

Public ContactWisit Prasitsirikul

Bamrasnaradura Infectious Diseases Institute

drwisit_p@yahoo.com029511170

Outcome results

None listed

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