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Completed

NCT Number: NCT05480774

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

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.

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Key information

Conditions

Healthy

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Centre of Clinical Pharmacology

Hanoi, Vietnam

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

KRG hard capsule

Drug

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

Placebo hard capsule

Drug

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

Primary outcomes

  1. Adverse events associated with the administration of KRG

    Time frame: 12 weeks

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

Secondary outcomes

  1. Natural killer (NK) cell count

    Time frame: 12 weeks

    Change in NK cell count after 12 weeks compared to baseline

  2. White blood cell count

    Time frame: 12 weeks

    Change in white blood cell count after 12 weeks compared to baseline

  3. Interferon (IFN)-α, β, γ levels

    Time frame: 12 weeks

    Changes in IFN-α, β, γ levels after 12 weeks compared to baseline

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

    Time frame: 12 weeks

    Changes in TNF-α, β, γ levels after 12 weeks compared to baseline

  5. Interleukin (IL)-1, 4, 6 levels

    Time frame: 12 weeks

    Changes in IL-1, 4, 6 levels after 12 weeks compared to baseline

Sponsors and collaborators

Lead sponsor

Centre of Clinical Pharmacology, Hanoi Medical University

Other

Collaborators

  • HK inno.N Corporation
  • Kyunghee University

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jul 29, 2022
Registry last updated
Jan 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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