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

Primary Purpose

Covid19

Status
Unknown status
Phase
Phase 3
Locations
Thailand
Study Type
Interventional
Intervention
Andrographis Paniculata
Boesenbergia
Standard supportive treatment
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid19 focused on measuring Treatment, Andrographis, Boesenbergia, Covid19

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Faculty of Medicine Ramathibodi HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Other

Arm Label

Andrographis extract

Boesenbergia extract

Standard supportive treatment

Arm 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.

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 guideline from Ministry of Public Health, Thailand, there will be no antivirus given in this asymptomatic group

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Pneumonia
Pneumonia by diagnosis or chest radiography
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)
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

Full Information

First Posted
August 21, 2021
Last Updated
September 1, 2021
Sponsor
Mahidol University
Collaborators
Ministry of Health, Thailand
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1. Study Identification

Unique Protocol Identification Number
NCT05019326
Brief Title
Andrographis Paniculata vs Boesenbergia Rotunda vs Control in Asymptomatic COVID-19
Official Title
A Two-stage Adaptive Randomized Controlled Trial of Andrographis Paniculata Extract, Boesenbergia Rotunda Extract, and Standard Treatment in Asymptomatic COVID-19 Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 30, 2021 (Actual)
Primary Completion Date
May 30, 2022 (Anticipated)
Study Completion Date
May 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mahidol University
Collaborators
Ministry of Health, Thailand

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
Keywords
Treatment, Andrographis, Boesenbergia, Covid19

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
3060 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Andrographis extract
Arm Type
Experimental
Arm 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.
Arm Title
Boesenbergia extract
Arm Type
Experimental
Arm 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.
Arm Title
Standard supportive treatment
Arm Type
Other
Arm Description
Standard supportive treatment, as recommended by guideline from Ministry of Public Health, Thailand, there will be no antivirus given in this asymptomatic group
Intervention Type
Drug
Intervention Name(s)
Andrographis Paniculata
Intervention 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.
Intervention Type
Drug
Intervention Name(s)
Boesenbergia
Intervention 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.
Intervention Type
Other
Intervention Name(s)
Standard supportive treatment
Intervention Description
as recommended by guidelines from the Ministry of Public Health, Thailand. No antivirus was given.
Primary Outcome Measure Information:
Title
Require hospitalization in the hospital
Description
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
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Individual status from WHO clinical progression scale (0-10)
Description
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
Time Frame
28 days
Title
Pneumonia
Description
Pneumonia by diagnosis or chest radiography
Time Frame
28 days
Title
Quality of life by EQ5D-5L
Description
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)
Time Frame
28 days
Title
Side effect of medication
Description
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
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18- 60 years old Have been diagnosed as new COVID-19 case by RT-PCR since disease onset to admission less than 7 days Have asymptomatic infection assessed by the World Health Organization (WHO) disease category Do not have any of following disease or conditions Body weight > 90 kg or BMI > 30 kg/m2 Hypertension that needs antihypertensive medication Diabetes Cardiovascular diseases including congenital heart disease Cerebrovascular diseases Chronic kidney and chronic liver diseases COPD or chronic lung diseases Lymphocyte <1,000 cells/mm3 Late-stage cancer Auto-immune disease (e.g., SLE, Rheumatoid arthritis, multiple sclerosis, etc.) or currently on immunosuppressive drug Coagulation disorders or platelet disorders and are being treated with anticoagulants such as warfarin, clopidogrel Pregnancy Willing to participate with the study and sign inform consents. (Withdrawal criteria) Patients withdraw from the study Have severe adverse effect that may relate to Andographolide or Boesenbergia
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pawin Numthavaj
Phone
+6622011284
Email
pawin.num@mahidol.ac.th
Facility Information:
Facility Name
Faculty of Medicine Ramathibodi Hospital
City
Ratchathewi
State/Province
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pawin Numthavaj, MD
Phone
+6622011284
Email
pawin.num@mahidol.ac.th

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
May shared IPD upon sponsor decision.

Learn more about this trial

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

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