Andrographis Paniculata vs Boesenbergia Rotunda vs Control in Asymptomatic COVID-19
NCT ID: NCT05019326
Last Updated: 2021-09-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
3060 participants
INTERVENTIONAL
2021-08-30
2022-05-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Andrographis extract
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.
Andrographis Paniculata
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
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.
Boesenbergia
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
Standard supportive treatment, as recommended by guideline from Ministry of Public Health, Thailand, there will be no antivirus given in this asymptomatic group
Standard supportive treatment
as recommended by guidelines from the Ministry of Public Health, Thailand. No antivirus was given.
Interventions
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Andrographis Paniculata
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
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
as recommended by guidelines from the Ministry of Public Health, Thailand. No antivirus was given.
Eligibility Criteria
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Inclusion Criteria
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
18 Years
60 Years
ALL
No
Sponsors
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Ministry of Health, Thailand
OTHER_GOV
Mahidol University
OTHER
Responsible Party
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Locations
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Faculty of Medicine Ramathibodi Hospital
Ratchathewi, Bangkok, Thailand
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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MURA2021/652
Identifier Type: -
Identifier Source: org_study_id
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