Efficacy and safety of Orostachydis Herba extracts in immune function improvement : a single center, randomised, double blind, placebo-controlled, clinical trial
- Conditions
- Not Applicable
- Registration Number
- KCT0002123
- Lead Sponsor
- Pusan National University Korean Medicine Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 62
(1) adult male and female over the age of 45
(2) Those who can visit for follow up while study period, and can have examination which measured in this study including the blood collection
(3) Those who decided to voluntarily participate in this clinical trial, and signed research agreement(informed consent)
(1) Those with diseases or conditions that may affect the immune system (Ex: Infectious diseases, autoimmune diseases, blood diseases, malignant neoplasms, such as distinct malnutrition)
(2) Those who took drug that may affect the immune system (Ex: steroid, hormone) or may affect absorption, metabolism and excretion of trial food within a month recently.
(3) Those with gastrointestinal diseases, operation (except for a simple appendectomy surgery or hernia surgery) which may affect absorption of trial food
(4) Those with hypersensitivity reactions or side effects on Orostachydis Herba or similar plants
(5) Those who intake Excessive alcohol
- Male: more than 168g/week (about 3.5bottles/week as soju(Korean distilled spirits), about 12bottles/week as beer)
- Female: more than 112g/week (about 2.3bottles/week as soju(Korean distilled spirits), about 8bottles/week as beer)
(6) Pregnant women, nursing mothers and fertile women not using adequate contraception.
(7) Those deemed inappropriate to participate this clinical trial by research personnel or research director, due to other reasons
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The ratio of NK cell(percentage of NK cell among lymphocyte);The ratio of T-helper cell and T-suppressor cell(percentage of CD4+/CD8+ T cell)
- Secondary Outcome Measures
Name Time Method Total numbers of Blood leukocytes(WBC);The ratio of neutrophil, lymphocyte, monocyte among leukocyte;The ratio of T cell, T-helper cell, T-suppressor cell, B cell among Lymphocytes;amount of blood IgM, IgG, IgA, CMV IgG;blood metabolome analysis target & gobal analysis (LC/MS)