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

Covid19 Clinical Trial

Official title:

A Two-stage Adaptive Randomized Controlled Trial of Andrographis Paniculata Extract, Boesenbergia Rotunda Extract, and Standard Treatment in Asymptomatic COVID-19 Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05019326
• Other study ID #: MURA2021/652
• Status: Recruiting
• Phase: Phase 3
• Start date: August 30, 2021
• Est. completion date: May 30, 2022

Study information

• Verified date: September 2021
• Source: Mahidol University
• Contact: Pawin Numthavaj
• Phone: +6622011284
• Email: pawin.num[@]mahidol.ac.th
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3060
• Est. completion date: May 30, 2022
• Est. primary completion date: May 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Covid19

Intervention

Drug:
• 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.

Other:
• Standard supportive treatment
as recommended by guidelines from the Ministry of Public Health, Thailand. No antivirus was given.

Locations

Country	Name	City	State
Thailand	Faculty of Medicine Ramathibodi Hospital	Ratchathewi	Bangkok

Sponsors (2)

Lead Sponsor	Collaborator
Mahidol University	Ministry of Health, Thailand

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Require hospitalization in the hospital	From WHO clinical progression scale (0-10): 0: Uninfected with no viral RNA detected; Asymptomatic with viral RNA detected; Symptomatic and independent; Symptomatic with assistance needed; Hospitalized with no oxygen therapy needed; Hospitalized with oxygen mask or nasal prongs; Hospitalized with oxygen by NIV or high flow; Intubation and mechanical ventilation with pO2/FiO2 >= 150 or SpO2/FiO2 >= 200; Mechanical ventilation with pO2/FiO2 < 150 (SpO2/FiO2 <200) or vasopressor; Mechanical ventilation with pO2/FiO2 < 150 and vasopressor, dialysis, or ECMO; Dead; Outcome 4 or more considered as hospitalization	28 days
Secondary	Individual status from WHO clinical progression scale (0-10)	From WHO clinical progression scale: 0: Uninfected with no viral RNA detected; Asymptomatic with viral RNA detected; Symptomatic and independent; Symptomatic with assistance needed; Hospitalized with no oxygen therapy needed; Hospitalized with oxygen mask or nasal prongs; Hospitalized with oxygen by NIV or high flow; Intubation and mechanical ventilation with pO2/FiO2 >= 150 or SpO2/FiO2 >= 200; Mechanical ventilation with pO2/FiO2 < 150 (SpO2/FiO2 <200) or vasopressor; Mechanical ventilation with pO2/FiO2 < 150 and vasopressor, dialysis, or ECMO; Dead; More on the scale - worse outcome	28 days
Secondary	Pneumonia	Pneumonia by diagnosis or chest radiography	28 days
Secondary	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
Secondary	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