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A 8 week, randomized, double-blind, Placebo-controlled clinical trial of RB-F for the evaluation of efficacy and safety on immune function

A 8 week, randomized, double-blind, Placebo-controlled clinical trial of RB-F for the evaluation of efficacy and safety on immune function

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0002646
Enrollment
100
Registered
2018-01-09
Start date
2017-02-06
Completion date
Unknown
Last updated
2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Dietary Supplement : * Experimental Products(RB-F) • Main Component : RB-F(Fermented{Lentinus edodes} rice bran powder) • Weight : 400mg/capsules • Usage and Capacity : Intake 3 capsules/time and twic

Sponsors

STR Biotech
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Male or female subjects aged from 25 to 75 years old. 2) Screening white blood cell(WBC) ranged from 3X103 to 8X103cells/ul. 3) Stress self assessment scaled above "strong"(4 scales: none, moderate, strong, intense) 4) Subjects suffered from upper respiratory track infection or cold-related symptoms which have possibilities to cause upper respiratory track infection more than two times in the past one year. (*Tonsillitis, pharyngitis, laryngitis, sinusitis, otitis media, rhinitis, etc.) 5) Subjects who agreed to participate in this study and subjects(or legal representative) who signed written informed consent voluntarily.

Exclusion criteria

Exclusion criteria: 1) Subjects who have past history or currently in the treatment of significant clinical disease related to acute or chronic cardiovascular system, immune system, respiratory system, liver biliary, kidney and urinary tract, nervous system, musculoskeletal disorders, psychic, infection and blood neoplastic. (However, subjects are possible to participate in the study by the discretion of the study director) 2) Subjects who have uncontrolled high blood pressure. (Higher than 160/100mmHg, measured 10 minutes after stabilizing) 3) diabetes patients (fasting glucose level that is more than normal of this organization or had been taking or currently are taking a drug due to diabetes in the past 4) Subjects who got a vaccination within 3 months before screening. 5) Subjects whose AST (GOT) or ALT (GPT) exceeds 3 times of normal upper limit in the blood. 6) Subjects whose creatinine exceeds 3 times of normal upper limit in the blood 7) Subjects who had intaken or is intaking functional foods that have potential of affecting the immune system whitin 2 weeks s before screening. 8) Subjects who have complained of severe gastrointestinal symptoms such as heartburn, indigestion. 9) Subjects who are planning a pregnancy, breastfeeding during this study. 10) Subjects who are planning to participate other studies during this study. 11) Subjects who were involved in other human applied studies within 8 weeks of this study begins. 12) Subjects who are deemed to be inappropriate to this human applied study. 13) Subjects who are sensitive to foods or have food allergies.

Design outcomes

Secondary

MeasureTime frame
advers event;clinical pathology examination;vital sign (blood pressure, heart rate, body temperature), weight;Electrocardiogram

Primary

MeasureTime frame
NK cell activity (E:T ratio 12.5:1, 25:1, 50:1);Phagocytosis;Interferon-?, Interleukin-2, Interleukin-12;White Blood Cell count;participant's self evaluation regarding their health improvement

Countries

Korea, Republic of

Contacts

Public ContactPARK OCK

Chonbuk National University Hospital

eopark@jbctc.org+82-63-259-3050

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026