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| Name | Class |
|---|---|
| National Research and Innovation Agency of Indonesia | UNKNOWN |
| RSDC Wisma Atlet | UNKNOWN |
| PT. Bintang Toedjoe | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BEJO Red Ginger Extract | Dietary Supplement | BEJO Red Ginger Extract ingredients:
|
| Measure | Description | Time Frame |
|---|---|---|
| Nucleic acid conversion time from randomization to the date of negative RT-PCR test result on the determined examinations. | from randomization to day 14 or until hospital discharge |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | from randomization to day 14 or until hospital discharge |
| Assessment of IL-6 level |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events (AEs) and clinical worsening in patients hospitalized with COVID-19 should be referred to referral hospital. | Number of AEs and clinical worsening that are unusual, unexpected or assessed as related to the investigational product. | from randomization to day 14 or until hospital discharge |
Inclusion Criteria:
Exclusion Criteria:
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.
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Erlang Samoedro, MD | Contact | +62 812 9408 845 | erlangsamoedro@gmail.com | |
| Yenny Meliana, Dr. | Contact | +62 21 756 0929 | prkimia@brin.go.id |
| Name | Affiliation | Role |
|---|---|---|
| Erlang Samoedro, MD | Persahabatan General Hospital | Principal Investigator |
| Intan Satwika Putri, S.T, M.T | National Research and Innovation Agency of Indonesia | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RSDC Wisma Atlet Kemayoran | Recruiting | Jakarta | 10640 | Indonesia |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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patient will be randomized 1:1 to placebo with SOC and BEJO Red Ginger with standard of care (SOC).
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|
| Placebo | Other | Placebo composition: Substance without active ingredient |
|
Changes from baseline in IL-6 |
| from randomization to day 14 or until hospital discharge |
| Assessment of TNF-alfa level | Changes from baseline in TNF-alfa | from randomization to day 14 or until hospital discharge |
| Biochemical assessment of serum SGOT level |
Concentration of serum SGOT level in I/U. Biochemical assessment is measured 2 times: at the baseline and hospital discharge or the first of negative RT-PCR test result. |
| from randomization to day 14 or until hospital discharge |
| Biochemical assessment of serum SGPT level | Concentration of serum SGPT level in I/U. Biochemical assessment is measured 2 times: at the baseline and hospital discharge or the first of negative RT-PCR test result. | from randomization to day 14 or until hospital discharge |
| Biochemical assessment of urea level | Concentration of urea level in mg/dl. Biochemical assessment is measured 2 times: at the baseline and hospital discharge or the first of negative RT-PCR test result. | from randomization to day 14 or until hospital discharge |
| Biochemical assessment of creatinine level | Concentration of creatinine level in mg/dl. Biochemical assessment is measured 2 times: at the baseline and hospital discharge or the first of negative RT-PCR test result. | from randomization to day 14 or until hospital discharge |
| Peripheral blood smear test | Assessment of blood cell count for diagnosis of Covid-19 associated inflammation. | from randomization to day 14 or until hospital discharge |
| Putro Setyobudyo Muhammad, MD |
| RSDC Wisma Atlet |
| Study Chair |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |