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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
168
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
Placebo composition: Substance without active ingredient
RSDC Wisma Atlet Kemayoran
Jakarta, Indonesia
RECRUITINGNucleic 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
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.
Time frame: from randomization to day 14 or until hospital discharge
Assessment of IL-6 level
Changes from baseline in IL-6
Time frame: from randomization to day 14 or until hospital discharge
Assessment of TNF-alfa level
Changes from baseline in TNF-alfa
Time frame: from randomization to day 14 or until hospital discharge
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