Covid19Phase 3NCT05019326
Andrographis Paniculata vs Boesenbergia Rotunda vs Control in Asymptomatic COVID-19
A Phase 3 study testing Andrographis Paniculata, Boesenbergia and Standard supportive treatment in people with Covid19, run by Mahidol University at 1 site in Thailand.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Covid19
- What is being tested?
- Andrographis Paniculata, Boesenbergia and Standard supportive treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,060 participants
- Where
- 1 siteThailand
- Study dates
- 30 Aug 2021to 30 May 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Show all 20Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Faculty of Medicine Ramathibodi Hospital
Ratchathewi, Bangkok, 10400
Pawin Numthavaj, MD, +6622011284, pawin.num@mahidol.ac.th
About this study
Official title: A Two-stage Adaptive Randomized Controlled Trial of Andrographis Paniculata Extract, Boesenbergia Rotunda Extract, and Standard Treatment in Asymptomatic COVID-19 Patients
The purpose of this study is to examine the effect of Andrographis Extract, Boesenbergia Extract compared to standard treatment in asymptomatic COVID patients.
- Conditions
- Covid19
- Being tested
- Andrographis Paniculata, Boesenbergia, Standard supportive treatment
- Keywords
- Treatment, Andrographis, Boesenbergia, Covid19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
Standard supportive treatmentOther
as recommended by guidelines from the Ministry of Public Health, Thailand. No antivirus was given.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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 Receives: Other: Standard supportive treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 28 days
Secondary outcomes (4)
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
Measured: 28 days
Pneumonia
Pneumonia by diagnosis or chest radiography
Measured: 28 days
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)
Measured: 28 days
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
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2021
- Study start30 Aug 2021
- Primary completion30 May 2022 (estimated)
- Study completion30 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 3,060 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Thailand
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05019326
- Sponsor's protocol ID
- MURA2021/652
- Status last verified
- Sep 2021
- First submitted
- 21 Aug 2021
- Last updated
- 9 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: May shared IPD upon sponsor decision.
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-stage Adaptive Randomized Controlled Trial of Andrographis Paniculata Extract, Boesenbergia Rotunda Extract, and Standard Treatment in Asymptomatic COVID-19 Patients
- ClinicalTrials.gov ID
- NCT05019326
- Acronym / sponsor ID
- MURA2021/652
- Conditions
- Covid19
- Keywords
- Treatment, Andrographis, Boesenbergia, Covid19
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3,060 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Collaborators
- Ministry of Health, Thailand
- Study start
- 30 Aug 2021 (actual)
- Primary completion
- 30 May 2022 (estimated)
- Study completion
- 30 May 2022 (estimated)
- First posted
- 24 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to examine the effect of Andrographis Extract, Boesenbergia Extract compared to standard treatment in asymptomatic COVID patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Andrographis extract | Experimental | Drug: Andrographis PaniculataAndrographis 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 | Experimental | Drug: BoesenbergiaBoesenbergia 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 | Other | Other: Standard supportive treatmentStandard supportive treatment, as recommended by guideline from Ministry of Public Health, Thailand, there will be no antivirus given in this asymptomatic group |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (20 listed)
- 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
- Willing to participate with the study and sign inform consents.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Andrographis PaniculataAndrographis 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 extract |
| BoesenbergiaBoesenbergia 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 extract |
| Standard supportive treatmentas recommended by guidelines from the Ministry of Public Health, Thailand. No antivirus was given. | Other | Standard supportive treatment |
Primary outcome
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
4 secondary outcomes
Individual status from WHO clinical progression scale (0-10)
Time frame: 28 days
Pneumonia
Time frame: 28 days
Quality of life by EQ5D-5L
Time frame: 28 days
Side effect of medication
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2021.
- Individual participant dataSharing planned: Undecided. May shared IPD upon sponsor decision.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Andrographis Paniculata, Boesenbergia and Standard supportive treatment in people with Covid19, run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pawin Numthavaj (+6622011284, pawin.num@mahidol.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Require hospitalization in the hospital (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2021.