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

COVID-19 Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05277155
• Other study ID #: 20-12-1505
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: February 22, 2022
• Est. completion date: August 22, 2022

Study information

• Verified date: March 2022
• Source: Research Center for Chemistry, National Research and Innovation Agency of Indonesia
• Contact: Erlang Samoedro, MD
• Phone: +62 812 9408 845
• Email: erlangsamoedro[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 168
• Est. completion date: August 22, 2022
• Est. primary completion date: July 22, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Intervention

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

Locations

Country	Name	City	State
Indonesia	RSDC Wisma Atlet Kemayoran	Jakarta

Sponsors (4)

Lead Sponsor	Collaborator
Research Center for Chemistry, National Research and Innovation Agency of Indonesia	National Research and Innovation Agency of Indonesia, PT. Bintang Toedjoe, RSDC Wisma Atlet

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of adverse events (AEs) and clinical worsening in patients hospitalized with COVID-19 should be referred to referral hospital.	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
Other	Biochemical assessment of serum SGOT level	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
Other	Biochemical assessment of serum SGPT level	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
Other	Biochemical assessment of urea level	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
Other	Biochemical assessment of creatinine level	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
Other	Peripheral blood smear test	Assessment of blood cell count for diagnosis of Covid-19 associated inflammation.	from randomization to day 14 or until hospital discharge
Primary	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	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.	from randomization to day 14 or until hospital discharge
Secondary	Assessment of IL-6 level	Changes from baseline in IL-6	from randomization to day 14 or until hospital discharge
Secondary	Assessment of TNF-alfa level	Changes from baseline in TNF-alfa	from randomization to day 14 or until hospital discharge