Andrographis Paniculata vs Boesenbergia Rotunda vs Control in Asymptomatic COVID-19

NCT ID: NCT05019326

Last Updated: 2021-09-09

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

3060 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-30

Study Completion Date

2022-05-30

Brief Summary

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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.

Detailed Description

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Conditions

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Covid19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

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.

Group Type EXPERIMENTAL

Andrographis Paniculata

Intervention Type 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.

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.

Group Type EXPERIMENTAL

Boesenbergia

Intervention Type 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

Standard supportive treatment, as recommended by guideline from Ministry of Public Health, Thailand, there will be no antivirus given in this asymptomatic group

Group Type OTHER

Standard supportive treatment

Intervention Type OTHER

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.

Intervention Type DRUG

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.

Intervention Type DRUG

Standard supportive treatment

as recommended by guidelines from the Ministry of Public Health, Thailand. No antivirus was given.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Health, Thailand

OTHER_GOV

Sponsor Role collaborator

Mahidol University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Faculty of Medicine Ramathibodi Hospital

Ratchathewi, Bangkok, Thailand

Site Status RECRUITING

Countries

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Thailand

Central Contacts

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Pawin Numthavaj

Role: CONTACT

+6622011284

Facility Contacts

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Pawin Numthavaj, MD

Role: primary

+6622011284

Other Identifiers

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MURA2021/652

Identifier Type: -

Identifier Source: org_study_id

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