Covid19
Conditions
Keywords
Treatment, Andrographis, Boesenbergia, Covid19
Brief summary
The purpose of this study is to examine the effect of Andrographis Extract, Boesenbergia Extract compared to standard treatment in asymptomatic COVID patients.
Interventions
Andrographis extract, equivalent to andrographolide 20 mg per capsule, for a total of 180 mg of andrographolide per day, dosing into 3 capsules taking before meal for 3 times per day, for 5 days.
DRUGBoesenbergia
Boesenbergia extract, equivalent to pinostrobin 30 mg per capsule, for a total of 180 mg of pinostrobin per day, dosing into 2 capsules taking after meal for 3 times per day for 5 days.
as recommended by guidelines from the Ministry of Public Health, Thailand. No antivirus was given.
Sponsors
Ministry of Health, Thailand
Mahidol University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18- 60 years old 2. Have been diagnosed as new COVID-19 case by RT-PCR since disease onset to admission less than 7 days 3. Have asymptomatic infection assessed by the World Health Organization (WHO) disease category 4. Do not have any of following disease or conditions 1. Body weight \> 90 kg or BMI \> 30 kg/m2 2. Hypertension that needs antihypertensive medication 3. Diabetes 4. Cardiovascular diseases including congenital heart disease 5. Cerebrovascular diseases 6. Chronic kidney and chronic liver diseases 7. COPD or chronic lung diseases 8. Lymphocyte \<1,000 cells/mm3 9. Late-stage cancer 10. Auto-immune disease (e.g., SLE, Rheumatoid arthritis, multiple sclerosis, etc.) or currently on immunosuppressive drug 11. Coagulation disorders or platelet disorders and are being treated with anticoagulants such as warfarin, clopidogrel 12. Pregnancy 5. Willing to participate with the study and sign inform consents. (Withdrawal criteria) 1. Patients withdraw from the study 2. Have severe adverse effect that may relate to Andographolide or Boesenbergia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Require hospitalization in the hospital | 28 days | From WHO clinical progression scale (0-10): 0: Uninfected with no viral RNA detected 1. Asymptomatic with viral RNA detected 2. Symptomatic and independent 3. Symptomatic with assistance needed 4. Hospitalized with no oxygen therapy needed 5. Hospitalized with oxygen mask or nasal prongs 6. Hospitalized with oxygen by NIV or high flow 7. Intubation and mechanical ventilation with pO2/FiO2 \>= 150 or SpO2/FiO2 \>= 200 8. Mechanical ventilation with pO2/FiO2 \< 150 (SpO2/FiO2 \<200) or vasopressor 9. Mechanical ventilation with pO2/FiO2 \< 150 and vasopressor, dialysis, or ECMO 10. Dead Outcome 4 or more considered as hospitalization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Individual status from WHO clinical progression scale (0-10) | 28 days | From WHO clinical progression scale: 0: Uninfected with no viral RNA detected 1. Asymptomatic with viral RNA detected 2. Symptomatic and independent 3. Symptomatic with assistance needed 4. Hospitalized with no oxygen therapy needed 5. Hospitalized with oxygen mask or nasal prongs 6. Hospitalized with oxygen by NIV or high flow 7. Intubation and mechanical ventilation with pO2/FiO2 \>= 150 or SpO2/FiO2 \>= 200 8. Mechanical ventilation with pO2/FiO2 \< 150 (SpO2/FiO2 \<200) or vasopressor 9. Mechanical ventilation with pO2/FiO2 \< 150 and vasopressor, dialysis, or ECMO 10. Dead More on the scale - worse outcome |
| Pneumonia | 28 days | Pneumonia by diagnosis or chest radiography |
| Quality of life by EQ5D-5L | 28 days | Quality of life by EQ5D-5L Scale of 0 to 100 for overall health state (lower is worse) and 1 to 5 in each of 5 domains. (higher score is worse) |
| Side effect of medication | 28 days | Renal and liver function elevation and other anticipated/unanticipated side effect: Side effect of medication will be classified according to common terminology criteria for adverse events (CTCAE) version 5.0 |
Countries
Thailand
Contacts
Primary ContactPawin Numthavaj
Outcome results
None listed