NCT05019326

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,060

participants targeted

Target at P75+ for phase_3 covid19

Timeline
Completed

Started Aug 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 21, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 24, 2021

Completed
6 days until next milestone

Study Start

First participant enrolled

August 30, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2022

Completed
Last Updated

September 9, 2021

Status Verified

September 1, 2021

Enrollment Period

9 months

First QC Date

August 21, 2021

Last Update Submit

September 1, 2021

Conditions

Covid19

Keywords

TreatmentAndrographisBoesenbergiaCovid19

Outcome Measures

Primary Outcomes (1)

  • Require hospitalization in the hospital

    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

    28 days

Secondary Outcomes (4)

  • Individual status from WHO clinical progression scale (0-10)

    28 days

  • Pneumonia

    28 days

  • Quality of life by EQ5D-5L

    28 days

  • Side effect of medication

    28 days

Study Arms (3)

Andrographis extract

EXPERIMENTAL

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

Boesenbergia extract

EXPERIMENTAL

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

Standard supportive treatment

OTHER

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

Interventions

Andrographis PaniculataDRUG

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.

Andrographis extract
BoesenbergiaDRUG

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.

Boesenbergia extract
Standard supportive treatmentOTHER

as recommended by guidelines from the Ministry of Public Health, Thailand. No antivirus was given.

Standard supportive treatment

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine Ramathibodi Hospital

Ratchathewi, Bangkok, 10400, Thailand

RECRUITING

MeSH Terms

Conditions

COVID-19

Interventions

Andrographis paniculata extract

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Central Study Contacts

Pawin Numthavaj

CONTACT

+6622011284pawin.num@mahidol.ac.th

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 21, 2021

First Posted

August 24, 2021

Study Start

August 30, 2021

Primary Completion

May 30, 2022

Study Completion

May 30, 2022

Last Updated

September 9, 2021

Record last verified: 2021-09

Locations

TH(1)