- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05277155
Trial to Study the Efficacy and Safety of BEJO Red Ginger in COVID-19 Patients With Mild Symptoms
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
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Contact
- Name: Erlang Samoedro, MD
- Phone Number: +62 812 9408 845
- Email: erlangsamoedro@gmail.com
Study Contact Backup
- Name: Yenny Meliana, Dr.
- Phone Number: +62 21 756 0929
- Email: prkimia@brin.go.id
Study Locations
-
-
-
Jakarta, Indonesia, 10640
- Recruiting
- RSDC Wisma Atlet Kemayoran
-
Contact:
- Tri Widyanti, MD
- Phone Number: +62 878 3465 7757
- Email: triwidyantikesuma@gmail.com
-
Contact:
- Putro Setyobudyo Muhammad, MD
- Phone Number: +62 812 9159 4700
- Email: putrosm.darsono@gmail.com
-
Principal Investigator:
- Erlang Samoedro, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention Group (BEJO Red Ginger Extract)
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)
|
BEJO Red Ginger Extract ingredients:
|
Placebo Comparator: Control Group (Placebo)
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)
|
Placebo composition: Substance without active ingredient
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
from randomization to day 14 or until hospital discharge
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical improvement; from initiation of study treatment (active or placebo) and daily anamnesis.
Time Frame: from randomization to day 14 or until hospital discharge
|
Time to clinical improvement, defined as the time from randomization to improvement of subjects' clinical status.
|
from randomization to day 14 or until hospital discharge
|
Assessment of IL-6 level
Time Frame: from randomization to day 14 or until hospital discharge
|
Changes from baseline in IL-6
|
from randomization to day 14 or until hospital discharge
|
Assessment of TNF-alfa level
Time Frame: from randomization to day 14 or until hospital discharge
|
Changes from baseline in TNF-alfa
|
from randomization to day 14 or until hospital discharge
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of adverse events (AEs) and clinical worsening in patients hospitalized with COVID-19 should be referred to referral hospital.
Time Frame: from randomization to day 14 or until hospital discharge
|
Number of AEs and clinical worsening that are unusual, unexpected or assessed as related to the investigational product.
|
from randomization to day 14 or until hospital discharge
|
Biochemical assessment of serum SGOT level
Time Frame: from randomization to day 14 or until hospital discharge
|
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.
|
from randomization to day 14 or until hospital discharge
|
Biochemical assessment of serum SGPT level
Time Frame: from randomization to day 14 or until hospital discharge
|
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.
|
from randomization to day 14 or until hospital discharge
|
Biochemical assessment of urea level
Time Frame: from randomization to day 14 or until hospital discharge
|
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.
|
from randomization to day 14 or until hospital discharge
|
Biochemical assessment of creatinine level
Time Frame: from randomization to day 14 or until hospital discharge
|
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.
|
from randomization to day 14 or until hospital discharge
|
Peripheral blood smear test
Time Frame: from randomization to day 14 or until hospital discharge
|
Assessment of blood cell count for diagnosis of Covid-19 associated inflammation.
|
from randomization to day 14 or until hospital discharge
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Erlang Samoedro, MD, Persahabatan General Hospital
- Study Director: Intan Satwika Putri, S.T, M.T, National Research and Innovation Agency of Indonesia
- Study Chair: Putro Setyobudyo Muhammad, MD, RSDC Wisma Atlet
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20-12-1505
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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