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

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.

Conditions

• COVID-19

Interventions

DIETARY_SUPPLEMENT

BEJO Red Ginger Extract

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

OTHER

Placebo

Placebo composition: Substance without active ingredient

Sponsors & Collaborators

• National Research and Innovation Agency of Indonesia

  collaborator UNKNOWN

• RSDC Wisma Atlet

  collaborator UNKNOWN

• PT. Bintang Toedjoe

  collaborator UNKNOWN

• Research Center for Chemistry, National Research and Innovation Agency of Indonesia

  lead OTHER_GOV

Principal Investigators

• Erlang Samoedro, MD · Persahabatan General Hospital

• Intan Satwika Putri, S.T, M.T · National Research and Innovation Agency of Indonesia

• Putro Setyobudyo Muhammad, MD · RSDC Wisma Atlet

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

50 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-02-22

Primary Completion

2022-07-22

Completion

2022-08-22

Countries

• Indonesia

Study Locations