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| Name | Class |
|---|---|
| Ministry of Health, Thailand | OTHER_GOV |
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The purpose of this study is to examine the effect of Andrographis Extract, Boesenbergia Extract compared to standard treatment in asymptomatic COVID patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Andrographis extract | Experimental | 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 | Experimental | 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. |
|
| Standard supportive treatment | Other | Standard supportive treatment, as recommended by guideline from Ministry of Public Health, Thailand, there will be no antivirus given in this asymptomatic group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Andrographis Paniculata | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Require hospitalization in the hospital | From WHO clinical progression scale (0-10): 0: Uninfected with no viral RNA detected
Outcome 4 or more considered as hospitalization | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Individual status from WHO clinical progression scale (0-10) | From WHO clinical progression scale: 0: Uninfected with no viral RNA detected
More on the scale - worse outcome |
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Inclusion Criteria:
Age 18- 60 years old
Have been diagnosed as new COVID-19 case by RT-PCR since disease onset to admission less than 7 days
Have asymptomatic infection assessed by the World Health Organization (WHO) disease category
Do not have any of following disease or conditions
Willing to participate with the study and sign inform consents.
(Withdrawal criteria)
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pawin Numthavaj | Contact | +6622011284 | pawin.num@mahidol.ac.th |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine Ramathibodi Hospital | Recruiting | Ratchathewi | Bangkok | 10400 | Thailand |
May shared IPD upon sponsor decision.
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C000713167 | Andrographis paniculata extract |
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| Boesenbergia | Drug | 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. |
|
| Standard supportive treatment | Other | as recommended by guidelines from the Ministry of Public Health, Thailand. No antivirus was given. |
|
| 28 days |
| Pneumonia | Pneumonia by diagnosis or chest radiography | 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) | 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 | 28 days |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |