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

Phase 3

• Conditions: Covid19
• Interventions: Drug: Boesenbergia; Drug: Andrographis Paniculata; Other: Standard supportive treatment

• Registration Number: NCT05019326
• Lead Sponsor: Mahidol University

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2021-08-21
• Study First Submitted QC: 2021-08-21
• Study First Posted: 2021-08-24
• Study Start: 2021-08-30
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-01
• Last Update Posted: 2021-09-09
• Primary Completion: 2022-05-30
• Study Completion: 2022-05-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 3060

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Boesenbergia extract	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.
Andrographis extract	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.
Standard supportive treatment	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

Primary Outcome Measures

Name	Time	Method
Require hospitalization in the hospital	28 days	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

Secondary Outcome Measures

Name	Time	Method
Individual status from WHO clinical progression scale (0-10)	28 days	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
Pneumonia	28 days	Pneumonia by diagnosis or chest radiography
Quality of life by EQ5D-5L	28 days	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)
Side effect of medication	28 days	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

Trial Locations

Locations (1)

Faculty of Medicine Ramathibodi Hospital; 🇹🇭 Ratchathewi, Bangkok, Thailand