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

NCT05277155 | Unknown Phase 2 DMC

• 1 other identifier: 20-12-1505
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

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 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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Clinical improvement; from initiation of study treatment (active or placebo) and daily anamnesis.

  from randomization to day 14 or until hospital discharge

• Assessment of IL-6 level

  from randomization to day 14 or until hospital discharge

• Assessment of TNF-alfa level

  from randomization to day 14 or until hospital discharge

Other Outcomes (6)

• Incidence of adverse events (AEs) and clinical worsening in patients hospitalized with COVID-19 should be referred to referral hospital.

  from randomization to day 14 or until hospital discharge

• Biochemical assessment of serum SGOT level

  from randomization to day 14 or until hospital discharge

• Biochemical assessment of serum SGPT level

  from randomization to day 14 or until hospital discharge

Study Arms (2)

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)

Dietary Supplement: BEJO Red Ginger Extract

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)

Other: Placebo

Interventions

BEJO Red Ginger Extract DIETARY_SUPPLEMENT

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

Intervention Group (BEJO Red Ginger Extract)

Placebo OTHER

Placebo composition: Substance without active ingredient

Control Group (Placebo)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Research Center for Chemistry, National Research and Innovation Agency of Indonesia: lead
• National Research and Innovation Agency of Indonesia: collaborator
• RSDC Wisma Atlet: collaborator
• PT. Bintang Toedjoe: collaborator

Study Sites (1)

RSDC Wisma Atlet Kemayoran

Jakarta, 10640, Indonesia

RECRUITING

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Erlang Samoedro, MD

  Persahabatan General Hospital

  PRINCIPAL INVESTIGATOR

• Intan Satwika Putri, S.T, M.T

  National Research and Innovation Agency of Indonesia

  STUDY DIRECTOR

• Putro Setyobudyo Muhammad, MD

  RSDC Wisma Atlet

  STUDY CHAIR

Central Study Contacts

Erlang Samoedro, MD

CONTACT

+62 812 9408 845; erlangsamoedro@gmail.com

Yenny Meliana, Dr.

CONTACT

+62 21 756 0929; prkimia@brin.go.id

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: patient will be randomized 1:1 to placebo with SOC and BEJO Red Ginger with standard of care (SOC).

Study Record Dates

• First Submitted: March 4, 2022
• First Posted: March 14, 2022
• Study Start: February 22, 2022
• Primary Completion: July 22, 2022
• Study Completion: August 22, 2022
• Last Updated: March 14, 2022

Record last verified: 2022-03

Locations

ID (1)