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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05019326
Recruitment Status : Recruiting
First Posted : August 24, 2021
Last Update Posted : September 9, 2021
Sponsor:
Collaborator:
Ministry of Health, Thailand
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Covid19 Drug: Andrographis Paniculata Drug: Boesenbergia Other: Standard supportive treatment Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3060 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Two-stage Adaptive Randomized Controlled Trial of Andrographis Paniculata Extract, Boesenbergia Rotunda Extract, and Standard Treatment in Asymptomatic COVID-19 Patients
Actual Study Start Date : August 30, 2021
Estimated Primary Completion Date : May 30, 2022
Estimated Study Completion Date : May 30, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
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.

Experimental: 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.
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.

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




Primary Outcome Measures :
  1. Require hospitalization in the hospital [ Time Frame: 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 :
  1. Individual status from WHO clinical progression scale (0-10) [ Time Frame: 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


  2. Pneumonia [ Time Frame: 28 days ]
    Pneumonia by diagnosis or chest radiography

  3. Quality of life by EQ5D-5L [ Time Frame: 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)


  4. Side effect of medication [ Time Frame: 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




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05019326


Contacts
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Contact: Pawin Numthavaj +6622011284 pawin.num@mahidol.ac.th

Locations
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Thailand
Faculty of Medicine Ramathibodi Hospital Recruiting
Ratchathewi, Bangkok, Thailand, 10400
Contact: Pawin Numthavaj, MD    +6622011284    pawin.num@mahidol.ac.th   
Sponsors and Collaborators
Mahidol University
Ministry of Health, Thailand
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Responsible Party: Mahidol University
ClinicalTrials.gov Identifier: NCT05019326    
Other Study ID Numbers: MURA2021/652
First Posted: August 24, 2021    Key Record Dates
Last Update Posted: September 9, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: May shared IPD upon sponsor decision.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mahidol University:
Treatment
Andrographis
Boesenbergia
Covid19
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Andrographolide
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antirheumatic Agents
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antiviral Agents
Platelet Aggregation Inhibitors