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

Mahidol University

Status and phase: Unknown; Phase 3

Conditions: Covid19

Treatments: Drug: Andrographis Paniculata; Drug: Boesenbergia; Other: Standard supportive treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT05019326

MURA2021/652

Details and patient eligibility

About

The purpose of this study is to examine the effect of Andrographis Extract, Boesenbergia Extract compared to standard treatment in asymptomatic COVID patients.

Enrollment: 3,060 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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3,060 participants in 3 patient groups

Andrographis extract

Experimental group

Description:

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.

Treatment:

Drug: Andrographis Paniculata

Boesenbergia extract

Experimental group

Description:

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.

Treatment:

Drug: Boesenbergia

Standard supportive treatment

Other group

Description:

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

Treatment:

Other: Standard supportive treatment