Trial to Study the Efficacy and Safety of BEJO Red Ginger in COVID-19 Patients With Mild Symptoms

Phase

2/3

Condition

Covid-19

Treatment

N/A

Clinical Study ID

NCT05277155

20-12-1505

Ages 18-50
All Genders

Study 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. 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Age 18 to 50 years, both sexes.
Newly diagnosed adult patients with positive SARS-COV-2 by Real Time-PCR, using anappropriate sample such as nasopharyngeal, oropharyngeal, or nasal swab (within 3 daysprior to study enrolment).
Patients diagnosed with mild clinical manifestations, according to the Management ofCOVID-19 patients issued by The Indonesian Society of Respirology (KepmenkesHK.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 theinstitutional review board approved consent form prior to participating.

Exclusion

Exclusion Criteria:

Asymptomatic COVID-19 patients
Presence of any of the following abnormal laboratory values:
Elevation in serum glutamic oxaloacetic transaminase (SGOT) and/ or serumglutamic pyruvic transaminase (SGPT) of greater than 5 times the upper limit ofnormal (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 ofnormal (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, congestiveheart failure, arrhythmia, liver diseases, hypertension, diabetes mellitus (DM) type 1and 2, glucocorticoid-induced DM, geriatric syndromes, autoimmune diseases, severerenal impairment, myocardial infarction, chronic obstructive pulmonary diseases (including asthma, tuberculosis) , and malignancies. The medical history wasdetermined by from the statement of prospective subjects.
Patients with ST-segment elevation myocardial infarction (STEMI) and non-ST-segmentelevation 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-10in RSDC Wisma Atlet.
Patient who has allergies to the test product.
Active participation in other drug clinical trials.

Study Design

February 22, 2022

August 22, 2022

Connect with a study center

RSDC Wisma Atlet Kemayoran
Jakarta, 10640
Indonesia
Active - Recruiting

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