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

NCT ID: NCT05480774

Last Updated: 2023-01-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 101 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-06
• Study Completion Date: 2022-12-31

Brief Summary

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

KRG hard capsule

Intervention Type: DRUG

Each subject was given orally 2 KRG hard capsules/day for 12 weeks

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.

Group Type: PLACEBO_COMPARATOR

Placebo hard capsule

Intervention Type: DRUG

Each subject was given orally 2 placebo hard capsules/day for 12 weeks

Interventions

KRG hard capsule

Each subject was given orally 2 KRG hard capsules/day for 12 weeks

Intervention Type: DRUG

Placebo hard capsule

Each subject was given orally 2 placebo hard capsules/day for 12 weeks

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Kyunghee University

OTHER

Sponsor Role: collaborator

HK inno.N Corporation

INDUSTRY

Sponsor Role: collaborator

Centre of Clinical Pharmacology, Hanoi Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centre of Clinical Pharmacology

Hanoi, , Vietnam

Countries

Vietnam

Other Identifiers

BMRI-CT-2021-01

Identifier Type: -

Identifier Source: org_study_id