A Phase 3 interventional study of Andrographis Paniculata and Boesenbergia in Covid19, sponsored by Mahidol University. Status unknown at 1 site in Thailand. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2021-09-09.
Sponsored by Mahidol University · Phase 3, Interventional, and Treatment
The purpose of this study is to examine the effect of Andrographis Extract, Boesenbergia Extract compared to standard treatment in asymptomatic COVID patients.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's planned enrollment of 3,060 is above the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Mahidol University is the lead sponsor of 730 studies on the registry; 118 are open to participants now.
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Inclusion Criteria:
Do not have any of following disease or conditions
(Withdrawal criteria)
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.
Drug: Andrographis Paniculata
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.
Drug: Boesenbergia
Standard supportive treatment, as recommended by guideline from Ministry of Public Health, Thailand, there will be no antivirus given in this asymptomatic group
Other: Standard supportive treatment
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.
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.
Require hospitalization in the hospital
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
Time frame: 28 days
Individual status from WHO clinical progression scale (0-10)
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
Time frame: 28 days
Pneumonia
Pneumonia by diagnosis or chest radiography
Time frame: 28 days
Quality of life by EQ5D-5L
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)
Time frame: 28 days
Side effect of medication
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
Time frame: 28 days
Plan to share: Undecided — May shared IPD upon sponsor decision.
No publications or documents are linked to this record.
This study is status unknown, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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Mahidol University