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

Primary Purpose

COVID-19

Status

Recruiting

Phase

Phase 2

Locations

Indonesia

Study Type

Interventional

Intervention

BEJO Red Ginger Extract

Placebo

About this trial

This is an interventional treatment trial for COVID-19

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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 Criteria:

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.

Sites / Locations

RSDC Wisma Atlet KemayoranRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intervention Group (BEJO Red Ginger Extract)

Control Group (Placebo)

Arm Description

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)

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)

Outcomes

Primary Outcome Measures

Nucleic acid conversion time from randomization to the date of negative RT-PCR test result on the determined examinations.

Secondary Outcome Measures

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.

Assessment of IL-6 level

Changes from baseline in IL-6

Assessment of TNF-alfa level

Changes from baseline in TNF-alfa

Full Information

NCT ID

NCT05277155

First Posted

March 4, 2022

Last Updated

March 11, 2022

Sponsor

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

Collaborators

National Research and Innovation Agency of Indonesia, RSDC Wisma Atlet, PT. Bintang Toedjoe

1. Study Identification

Unique Protocol Identification Number

NCT05277155

Brief Title

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

Official Title

A Randomized, Controlled and Double-blinded Clinical Trial to Investigate the Efficacy and Safety of BEJO Red Ginger as an Adjuvant Therapy in COVID-19 Hospitalized Patients With Mild Symptoms

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Recruiting

Study Start Date

February 22, 2022 (Actual)

Primary Completion Date

July 22, 2022 (Anticipated)

Study Completion Date

August 22, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

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

Collaborators

National Research and Innovation Agency of Indonesia, RSDC Wisma Atlet, PT. Bintang Toedjoe

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COVID-19

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

168 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intervention Group (BEJO Red Ginger Extract)

Arm Type

Experimental

Arm Description

Arm Title

Control Group (Placebo)

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Dietary Supplement

Intervention Name(s)

BEJO Red Ginger Extract

Intervention Description

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 Type

Other

Intervention Name(s)

Placebo

Intervention Description

Placebo composition: Substance without active ingredient

Primary Outcome Measure Information:

Title

Nucleic 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

Secondary Outcome Measure Information:

Title

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

Description

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

Title

Assessment of IL-6 level

Description

Changes from baseline in IL-6

Time Frame

from randomization to day 14 or until hospital discharge

Title

Assessment of TNF-alfa level

Description

Changes from baseline in TNF-alfa

Time Frame

from randomization to day 14 or until hospital discharge

Other Pre-specified Outcome Measures:

Title

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

Description

Number of AEs and clinical worsening that are unusual, unexpected or assessed as related to the investigational product.

Time Frame

from randomization to day 14 or until hospital discharge

Title

Biochemical assessment of serum SGOT level

Description

Concentration of serum SGOT level in I/U. Biochemical assessment is measured 2 times: at the baseline and hospital discharge or the first of negative RT-PCR test result.

Time Frame

from randomization to day 14 or until hospital discharge

Title

Biochemical assessment of serum SGPT level

Description

Concentration of serum SGPT level in I/U. Biochemical assessment is measured 2 times: at the baseline and hospital discharge or the first of negative RT-PCR test result.

Time Frame

from randomization to day 14 or until hospital discharge

Title

Biochemical assessment of urea level

Description

Concentration of urea level in mg/dl. Biochemical assessment is measured 2 times: at the baseline and hospital discharge or the first of negative RT-PCR test result.

Time Frame

from randomization to day 14 or until hospital discharge

Title

Biochemical assessment of creatinine level

Description

Concentration of creatinine level in mg/dl. Biochemical assessment is measured 2 times: at the baseline and hospital discharge or the first of negative RT-PCR test result.

Time Frame

from randomization to day 14 or until hospital discharge

Title

Peripheral blood smear test

Description

Assessment of blood cell count for diagnosis of Covid-19 associated inflammation.

Time Frame

from randomization to day 14 or until hospital discharge

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Erlang Samoedro, MD

Phone

+62 812 9408 845

erlangsamoedro@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Yenny Meliana, Dr.

Phone

+62 21 756 0929

prkimia@brin.go.id

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Erlang Samoedro, MD

Organizational Affiliation

Persahabatan General Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Intan Satwika Putri, S.T, M.T

Organizational Affiliation

National Research and Innovation Agency of Indonesia

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Putro Setyobudyo Muhammad, MD

Organizational Affiliation

RSDC Wisma Atlet

Official's Role

Study Chair

Facility Information:

Facility Name

RSDC Wisma Atlet Kemayoran

City

Jakarta

ZIP/Postal Code

10640

Country

Indonesia

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Tri Widyanti, MD

Phone

+62 878 3465 7757

triwidyantikesuma@gmail.com

First Name & Middle Initial & Last Name & Degree

Putro Setyobudyo Muhammad, MD

Phone

+62 812 9159 4700

putrosm.darsono@gmail.com

First Name & Middle Initial & Last Name & Degree

Erlang Samoedro, MD

12. IPD Sharing Statement

Learn more about this trial

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

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