Effect of Red Ginseng Extract on Changes in Indicators of Immune Function in Vietnamese Healthy Volunteers

The Assessment for Effect of Red Ginseng Extract on Changes in Indicators of Immune Function in Vietnamese Healthy Volunteers: The Double-blind, Randomized, Placebo-controlled Trial

This is a placebo-controlled, randomized, double-blind, multiple dose study that evaluated the safety, tolerability, and changes in indicators of immune function of Korean Red Ginseng Extract in Vietnamese healthy subjects following oral administration of multiple dose of Korean Red Ginseng Extract as hard capsules or placebo to healthy adult men.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: KRG hard capsule; Drug: Placebo hard capsule

• Study Type: Interventional
• Enrollment (Actual): 101
• Phase: Phase 1

Contacts and Locations

Study Locations

• Vietnam
  • Hanoi, Vietnam
    • Centre of Clinical Pharmacology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy adult male or female aged 20 to 65 years, inclusive at the time of informed consent
• Have not any abnormalities of vital signs (temperature, systolic blood pressure (SBP) and diastolic blood pressure (DBP) and pulse rate), physical examinations, clinical laboratory tests (hematology, chemistry, and urinalysis).
• Ability and willingness to provide written informed consent and to comply with the requirements of the protocol.
• Peripheral white blood cells in the range of 3000 - 10,000/μL
• Subjects with a history of being infected with COVID-19 within 12 months according to the diagnostic criteria of the Ministry of Health at the time of infection

Exclusion Criteria:

• Pregnancy or lactation
• For subjects of reproductive potential, a positive result from a serum pregnancy test at screening, or not willing to use reliable means of contraception
• Evidence of clinically significant acute or chronic hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psych, neurological, or neoplastic diseases (however, at the discretion of the principal investigator, subjects may also be considered)
• Uncontrolled hypertension (SBP ≥160 mmHg and/or DBP ≥100 mmHg, measured following at least 10 mins of rest)
• Uncontrolled diabetes (fasting glucose level above 126 mg/dL or diabetic patients who have initial treatment with antidiabetic drugs for ≤ 3 months)
• Aspartate aminotransferase or alanine aminotransferase >=3.0 × upper limit of normal
• Serum creatinine level > 2,4 mg/dL for male and > 1,8 mg/dL for female
• Use of medications and dietary supplements that can affect immunity within 2 weeks before screening
• Those who complain of severe gastrointestinal symptoms such as heartburn and indigestion
• History of sensitivity or allergy to investigational product-related foods
• Plan to participate in other research while participating in this research
• Subject who, in the judgment of the Investigator, is likely to be non-compliant or uncooperative during the study.
• Failure of follow instructions for discontinuing immune-affecting dietary supplements during the wash-out period prior to trial participation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: KRG hard capsules; Each KRG hard capsule contains 500 mg of red ginseng extract. Dosage of KRG hard capsule: oral administration of 1 capsule twice daily for 12 weeks.	Drug: KRG hard capsule; Each subject was given orally 2 KRG hard capsules/day for 12 weeks
PLACEBO_COMPARATOR: Placebo hard capsules; The composition of the Placebo hard capsule contains red ginseng flavor. Dosage of Placebo hard capsule: oral administration of 1 capsule twice daily for 12 weeks.	Drug: Placebo hard capsule; Each subject was given orally 2 placebo hard capsules/day for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events associated with the administration of KRG	Frequency and characteristics of adverse events associated with the administration of KRG	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Natural killer (NK) cell count	Change in NK cell count after 12 weeks compared to baseline	12 weeks
White blood cell count	Change in white blood cell count after 12 weeks compared to baseline	12 weeks
Interferon (IFN)-α, β, γ levels	Changes in IFN-α, β, γ levels after 12 weeks compared to baseline	12 weeks
Tumor necrosis factor (TNF)-α, β, γ levels	Changes in TNF-α, β, γ levels after 12 weeks compared to baseline	12 weeks
Interleukin (IL)-1, 4, 6 levels	Changes in IL-1, 4, 6 levels after 12 weeks compared to baseline	12 weeks

Collaborators and Investigators

• Sponsor: Centre of Clinical Pharmacology, Hanoi Medical University
• Collaborators: HK inno.N Corporation; Kyunghee University

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 6, 2022
• Primary Completion (ACTUAL): December 3, 2022
• Study Completion (ACTUAL): December 31, 2022

Study Registration Dates

• First Submitted: July 26, 2022
• First Submitted That Met QC Criteria: July 28, 2022
• First Posted (ACTUAL): July 29, 2022

Study Record Updates

• Last Update Posted (ACTUAL): January 31, 2023
• Last Update Submitted That Met QC Criteria: January 30, 2023
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: BMRI-CT-2021-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No