Status:
UNKNOWN
Trial to Study the Efficacy and Safety of BEJO Red Ginger in COVID-19 Patients With Mild Symptoms
Lead Sponsor:
Research Center for Chemistry, National Research and Innovation Agency of Indonesia
Collaborating Sponsors:
National Research and Innovation Agency of Indonesia
RSDC Wisma Atlet
Conditions:
COVID-19
Eligibility:
All Genders
18-50 years
Phase:
PHASE2
PHASE3
Brief 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 m...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- 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.
Key Trial Info
Start Date :
February 22 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 22 2022
Estimated Enrollment :
168 Patients enrolled
Trial Details
Trial ID
NCT05277155
Start Date
February 22 2022
End Date
August 22 2022
Last Update
March 14 2022
Active Locations (1)
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1
RSDC Wisma Atlet Kemayoran
Jakarta, Indonesia, 10640