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

NCT05480774 | Completed Phase 1

• 1 other identifier: BMRI-CT-2021-01
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Adverse events associated with the administration of KRG

  Frequency and characteristics of adverse events associated with the administration of KRG

  12 weeks

Secondary Outcomes (5)

• Natural killer (NK) cell count

  12 weeks

• White blood cell count

  12 weeks

• Interferon (IFN)-α, β, γ levels

  12 weeks

• Tumor necrosis factor (TNF)-α, β, γ levels

  12 weeks

• Interleukin (IL)-1, 4, 6 levels

  12 weeks

Study Arms (2)

KRG hard capsules

ACTIVE COMPARATOR

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

Placebo hard capsules

PLACEBO COMPARATOR

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

Interventions

KRG hard capsule DRUG

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

KRG hard capsules

Placebo hard capsule DRUG

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

Placebo hard capsules

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre of Clinical Pharmacology, Hanoi Medical University: lead
• Kyunghee University: collaborator
• HK inno.N Corporation: collaborator

Study Sites (1)

Centre of Clinical Pharmacology

Hanoi, Vietnam

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2022
• First Posted: July 29, 2022
• Study Start: August 6, 2022
• Primary Completion: December 3, 2022
• Study Completion: December 31, 2022
• Last Updated: January 31, 2023

Record last verified: 2022-07

Locations

VN (1)