COVID-19Phase 2/3NCT05277155
Trial to Study the Efficacy and Safety of BEJO Red Ginger in COVID-19 Patients With Mild Symptoms
A Phase 2/3 study testing BEJO Red Ginger Extract in people with COVID-19, run by Research Center for Chemistry, National Research and Innovation Agency of Indonesia at 1 site in Indonesia.
Trial summary
This study is a randomized, double-blind, placebo-controlled clinical trial to investigate the safety and efficacy of BEJO Red Ginger in hospitalized adult (18 - 50 years old) COVID-19 patients with mild clinical manifestations. Subjects will be screened during hospitalization. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- COVID-19
- What is being tested?
- BEJO Red Ginger Extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 168 participants
- Where
- 1 siteIndonesia
- Study dates
- 22 Feb 2022to 22 Aug 2022
- Phase
- Phase 2/3
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18 to 50 years, both sexes.
- Newly diagnosed adult patients with positive SARS-COV-2 by Real Time-PCR, using an appropriate sample such as nasopharyngeal, oropharyngeal, or nasal swab (within 3 days prior to study enrolment).
- Patients diagnosed with mild clinical manifestations, according to the Management of COVID-19 patients issued by The Indonesian Society of Respirology (Kepmenkes HK.0107/MENKES/5671/2021). Mild symptoms including fever, cough, shortness of breath, myalgia, sore throat, anosmia, diarrhea, nauseous and other symptoms.
- Hospitalized patients.
- Subject must have provided written informed consent which includes signing the institutional review board approved consent form prior to participating.
Who cannot join
- Asymptomatic COVID-19 patients
- Presence of any of the following abnormal laboratory values:
- Elevation in serum glutamic oxaloacetic transaminase (SGOT) and/ or serum glutamic pyruvic transaminase (SGPT) of greater than 5 times the upper limit of normal (SGOT normal value 34 - 45 UI; SGPT normal value 31 - 35 UI)
- Elevation in urea and creatinine blood levels of greater than the upper limit of normal (Urea normal value 10 - 44 mg/dL; creatinine normal value 0.4 - 1.4 mg/dL)
- Patients with severe pneumonia.
- Patients with serious co-morbidity, including: coronary heart diseases, congestive heart failure, arrhythmia, liver diseases, hypertension, diabetes mellitus (DM) type 1 and 2, glucocorticoid-induced DM, geriatric syndromes, autoimmune diseases, severe renal impairment, myocardial infarction, chronic obstructive pulmonary diseases (including asthma, tuberculosis) , and malignancies. The medical history was determined by from the statement of prospective subjects.
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- Patients with ST-segment elevation myocardial infarction (STEMI) and non-ST-segment elevation myocardial infarction (NSTEMI), proved by an electrocardiogram (ECG) result.
- Be pregnant, confirmed with a negative pregnancy test.
- Lactating and breast feeding.
- Has consumed, or consuming herbal medicines or supplements other than SOC for COVID-10 in RSDC Wisma Atlet.
- Patient who has allergies to the test product.
- Active participation in other drug clinical trials.
Trial locations and contacts
1 site in 1 country.
Indonesia1 site, 1 recruiting
- Recruiting
RSDC Wisma Atlet Kemayoran
Jakarta, 10640
Tri Widyanti, MD, +62 878 3465 7757, triwidyantikesuma@gmail.com
Putro Setyobudyo Muhammad, MD, +62 812 9159 4700, putrosm.darsono@gmail.com
About this study
Official title: A Randomized, Controlled and Double-blinded Clinical Trial to Investigate the Efficacy and Safety of BEJO Red Ginger as an Adjuvant Therapy in COVID-19 Hospitalized Patients With Mild Symptoms
This study is a randomized, double-blind, placebo-controlled clinical trial to investigate the safety and efficacy of BEJO Red Ginger in hospitalized adult (18 - 50 years old) COVID-19 patients with mild clinical manifestations.
Subjects will be screened during hospitalization. One hundred and sixty-eight patients with confirmed SARS-CoV-2 infection and meeting all criteria, will be recruited to receive either BEJO Red Ginger or placebo in addition to standard of care (SOC) in a 1:1 ratio.
Patients with a diagnosis of COVID-19 and, due to mild symptoms, hospitalized, will be randomized to take a sachet of syrups containing 15 ml of BEJO Red Ginger, 3 times a day: 1 sachet after breakfast, 1 sachet after lunch, and 1 sachet after dinner, as add-on to the SOC, with 2 hours of incubation of SOC. The treatment will last for 14 days or until patients to be declared as cured. The treated patients will be compared with an equal group treated with placebo and SOC. Recovery time, symptoms, and objective (inflammatory) parameters (see detailed description) will be analyzed as outcomes. The goal of this study is to evaluate the role of BEJO Red Ginger in preventing progression of COVID-19 and accelerating healing process in patients.
- Conditions
- COVID-19
- Being tested
- BEJO Red Ginger Extract, Placebo
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BEJO Red Ginger ExtractDietary supplement
BEJO Red Ginger Extract ingredients:
- Zingiber officinale var. rubrum (Rhizome extract) 80 mg
- Foeniculi vulgare Fructus (Fennel) 25 mg
- Menthae arvensis Folium (Mint) 5 mg
- Piper retrofractum Fructus (Javanese long pepper) 12.5 mg
- Honey 7500 mg
PlaceboOther
Placebo composition: Substance without active ingredient
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group (BEJO Red Ginger Extract) | Experimental | 84 patients, dosage: BEJO Red Ginger Extract orally administrated 3 times a day each 15 mL plus the standard COVID-19 treatment as per hospital guideline with 2 hours interval time. (Time frame: from randomization to day 14 or until hospital discharge) Receives: Dietary Supplement: BEJO Red Ginger Extract |
| Control Group (Placebo) | Placebo comparator | 84 patients, dosage: Placebo orally administrated 3 times a day each 15 mL plus the standard COVID-19 treatment as per hospital guideline with 2 hours interval time. (Time frame: from randomization to day 14 or until hospital discharge) Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nucleic acid conversion time from randomization to the date of negative RT-PCR test result on the determined examinations.
Measured: from randomization to day 14 or until hospital discharge
Secondary outcomes (3)
Clinical improvement; from initiation of study treatment (active or placebo) and daily anamnesis.
Time to clinical improvement, defined as the time from randomization to improvement of subjects' clinical status.
Measured: from randomization to day 14 or until hospital discharge
Assessment of IL-6 level
Changes from baseline in IL-6
Measured: from randomization to day 14 or until hospital discharge
Assessment of TNF-alfa level
Changes from baseline in TNF-alfa
Measured: from randomization to day 14 or until hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2022
- Study start22 Feb 2022
- Primary completion22 Jul 2022 (estimated)
- Study completion22 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- patient will be randomized 1:1 to placebo with SOC and BEJO Red Ginger with standard of care (SOC).
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 168 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Research Center for Chemistry, National Research and Innovation Agency of Indonesia
- Sponsor type
- Other government
- Collaborators
- National Research and Innovation Agency of Indonesia, RSDC Wisma Atlet, PT. Bintang Toedjoe
- Responsible party
- Sponsor
- Investigators
- Erlang Samoedro, MD, Principal investigator, Persahabatan General HospitalIntan Satwika Putri, S.T, M.T, Study director, National Research and Innovation Agency of IndonesiaPutro Setyobudyo Muhammad, MD, Study chair, RSDC Wisma Atlet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05277155
- Sponsor's protocol ID
- 20-12-1505
- Status last verified
- Mar 2022
- First submitted
- 4 Mar 2022
- Last updated
- 14 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled and Double-blinded Clinical Trial to Investigate the Efficacy and Safety of BEJO Red Ginger as an Adjuvant Therapy in COVID-19 Hospitalized Patients With Mild Symptoms
- ClinicalTrials.gov ID
- NCT05277155
- Acronym / sponsor ID
- 20-12-1505
- Conditions
- COVID-19
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 168 participants (estimated)
- Lead sponsor
- Research Center for Chemistry, National Research and Innovation Agency of IndonesiaOther government
- Collaborators
- National Research and Innovation Agency of Indonesia, RSDC Wisma Atlet, PT. Bintang Toedjoe
- Study start
- 22 Feb 2022 (actual)
- Primary completion
- 22 Jul 2022 (estimated)
- Study completion
- 22 Aug 2022 (estimated)
- First posted
- 14 Mar 2022 (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.
This study is a randomized, double-blind, placebo-controlled clinical trial to investigate the safety and efficacy of BEJO Red Ginger in hospitalized adult (18 - 50 years old) COVID-19 patients with mild clinical manifestations.
Subjects will be screened during hospitalization. One hundred and sixty-eight patients with confirmed SARS-CoV-2 infection and meeting all criteria, will be recruited to receive either BEJO Red Ginger or placebo in addition to standard of care (SOC) in a 1:1 ratio.
Patients with a diagnosis of COVID-19 and, due to mild symptoms, hospitalized, will be randomized to take a sachet of syrups containing 15 ml of BEJO Red Ginger, 3 times a day: 1 sachet after breakfast, 1 sachet after lunch, and 1 sachet after dinner, as add-on to the SOC, with 2 hours of incubation of SOC. The treatment will last for 14 days or until patients to be declared as cured. The treated patients will be compared with an equal group treated with placebo and SOC. Recovery time, symptoms, and objective (inflammatory) parameters (see detailed description) will be analyzed as outcomes. The goal of this study is to evaluate the role of BEJO Red Ginger in preventing progression of COVID-19 and accelerating healing process in patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- patient will be randomized 1:1 to placebo with SOC and BEJO Red Ginger with standard of care (SOC).
| Arm | Type | Receives |
|---|---|---|
| Intervention Group (BEJO Red Ginger Extract) | Experimental | Dietary Supplement: BEJO Red Ginger Extract84 patients, dosage: BEJO Red Ginger Extract orally administrated 3 times a day each 15 mL plus the standard COVID-19 treatment as per hospital guideline with 2 hours interval time. (Time frame: from randomization to day 14 or until hospital discharge) |
| Control Group (Placebo) | Placebo comparator | Other: Placebo84 patients, dosage: Placebo orally administrated 3 times a day each 15 mL plus the standard COVID-19 treatment as per hospital guideline with 2 hours interval time. (Time frame: from randomization to day 14 or until hospital discharge) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age 18 to 50 years, both sexes.
- Newly diagnosed adult patients with positive SARS-COV-2 by Real Time-PCR, using an appropriate sample such as nasopharyngeal, oropharyngeal, or nasal swab (within 3 days prior to study enrolment).
- Patients diagnosed with mild clinical manifestations, according to the Management of COVID-19 patients issued by The Indonesian Society of Respirology (Kepmenkes HK.0107/MENKES/5671/2021). Mild symptoms including fever, cough, shortness of breath, myalgia, sore throat, anosmia, diarrhea, nauseous and other symptoms.
- Hospitalized patients.
- Subject must have provided written informed consent which includes signing the institutional review board approved consent form prior to participating.
Key exclusion criteria (12 listed)
- Asymptomatic COVID-19 patients
- Presence of any of the following abnormal laboratory values:
- Patients with severe pneumonia.
- Patients with serious co-morbidity, including: coronary heart diseases, congestive heart failure, arrhythmia, liver diseases, hypertension, diabetes mellitus (DM) type 1 and 2, glucocorticoid-induced DM, geriatric syndromes, autoimmune diseases, severe renal impairment, myocardial infarction, chronic obstructive pulmonary diseases (including asthma, tuberculosis) , and malignancies. The medical history was determined by from the statement of prospective subjects.
- Patients with ST-segment elevation myocardial infarction (STEMI) and non-ST-segment elevation myocardial infarction (NSTEMI), proved by an electrocardiogram (ECG) result.
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 |
|---|---|---|
| BEJO Red Ginger ExtractBEJO Red Ginger Extract ingredients: * Zingiber officinale var. rubrum (Rhizome extract) 80 mg * Foeniculi vulgare Fructus (Fennel) 25 mg * Menthae arvensis Folium (Mint) 5 mg * Piper retrofractum Fructus (Javanese long pepper) 12.5 mg * Honey 7500 mg | Dietary supplement | Intervention Group (BEJO Red Ginger Extract) |
| PlaceboPlacebo composition: Substance without active ingredient | Other | Control Group (Placebo) |
Primary outcome
Nucleic acid conversion time from randomization to the date of negative RT-PCR test result on the determined examinations.
Time frame: from randomization to day 14 or until hospital discharge
3 secondary outcomes
Clinical improvement; from initiation of study treatment (active or placebo) and daily anamnesis.
Time frame: from randomization to day 14 or until hospital discharge
Assessment of IL-6 level
Time frame: from randomization to day 14 or until hospital discharge
Assessment of TNF-alfa level
Time frame: from randomization to day 14 or until hospital discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2022.
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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.
Erlang Samoedro, MD principal investigator
Persahabatan General Hospital
Intan Satwika Putri, S.T, M.T study director
National Research and Innovation Agency of Indonesia
Putro Setyobudyo Muhammad, MD study chair
RSDC Wisma Atlet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing BEJO Red Ginger Extract in people with COVID-19, run by Research Center for Chemistry, National Research and Innovation Agency of Indonesia at 1 site in Indonesia.
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 5 inclusion and 12 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 14 Mar 2022. 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 Indonesia. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Erlang Samoedro, MD (+62 812 9408 845, erlangsamoedro@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nucleic acid conversion time from randomization to the date of negative RT-PCR test result on the determined examinations. (time frame: from randomization to day 14 or until hospital discharge). 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 14 Mar 2022.