A Study to Evaluate the Efficacy of Phellinus linteus Extract on Immune Functions.

Efficacy of Phellinus linteus (sanghuang) extract for improving immune functions: Study protocol for a randomized, double-blinded, placebo-controlled pilot trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0004272

Enrollment

Registered

2019-09-02

Start date

2019-12-17

Completion date

Unknown

Last updated

2020-01-14

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 : Test supplement1 : Phellinus linteus extract (1000 mg/day) Test supplement2 : Phellinus linteus extract (2000 mg/day) Placebo supplement: Placebo 8-week, 4 capsules/day, twice

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Male or female subjects aged from 20 to 65 years old. (2) white blood cell(WBC) ranged from 3000 to 8000 cells/ul. (3) 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. (4) Subjects who agreed to participate in this study and subjects(or legal representative) who signed written informed consent voluntarily.

Exclusion criteria

Exclusion criteria: (1) presence of clinically significant acute or chronic cardiovascular, immune, respiratory, liver, biliary, renal, and urological system, nervous system, musculoskeletal disease, psychological, infectious, and hematologic / teratogenic diseases.(possible to participate judged by the investigators considering the condition of the subject) (2) uncontrolled hypertension (above 160 / 100mmHg, after 10 minutes of rest) (3) uncontrolled diabetes (FBS(fasting blood sugar) level greater than 126 mg/dl or starting to taking new drugs due to diabetes) (4) vaccinated within 3 months before screening (5) AST(aspartate aminotransferase) or ALT(alanine aminotransferase) is more than 120 IU/L (6) Creatinine blood level is above 2.4mg/dL in men, 1.8mg/dL in women (7) ingested dietary supplements that can affect immune status within 2 weeks before screening (8) complain of severe gastrointestinal symptoms such as heartburn, indigestion, etc. (9) pregnant, breastfeeding or who have a pregnancy plan during this trial (10) plan to participate other trial during this trial (11) participated in other trial and ingested other drugs within 4 weeks of the start of this trial (12) judged by the investigators to be inappropriate for the clinical trial (13) sensitive or allergic to food for trial application

Design outcomes

Primary

Measure	Time frame
NK cell(natural killer cell) activity	—

Secondary

Measure	Time frame
White Blood Cell count;tumor necrosis factor-a;Interferon-?;Interleukin-1ß, Interleukin-2, Interleukin-6, Interleukin-12;Immunoglobulin G1, Immunoglobulin G2, Immunoglobulin M	—

Countries

Korea, Republic of

Contacts

Public ContactHwa-yeon Ryu

Cheonan Korean Medicine Hospital of Daejeon University

Outcome results