Human trial study to evaluate the efficacy and safety of ISD on immune functio

Not Applicable

Completed

• Conditions: Not Applicable

• Registration Number: KCT0004387
• Lead Sponsor: Medience

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 March 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1) Male or female subjects aged from 20 to 75 years old
2) Those that correspond to at least two of the following items
? Subjects who exercise more than 20 minutes a day (a severe physical activity that requires a little more
breathing than usual and a physical effort to increase heart rate) are within twice a week
? Subjects with a body mass index (BMI) of less than 18.5 kg/m2 or more than 27.5 kg/m2
? Triglyceride more than 150mg/dL
? HDL-C of less than male 40mg/dL or female 50mg/dL
? Subjects who have smoked more than 20 pieces a day and more than 3 years
? 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, Stomatitis, etc.)
3) Subjects with a Perceived Stress Scale(PSS) index of 18 or above
4) Satisfied with 1)~3) and subjects who decided to voluntarily participate in this clinical trial and complete to sign on the informed consent

Exclusion Criteria

1) Subjects who have clinically significant hypersensitivity history due to drug, experimental product or ingredients
2) subject who have thyroid gland or pituitary gland disease
3) Subjects who have acute severe cerebrovascular and cardiovascular disease such as renal failure, myocardial infarction, stroke
4) Subjects who have immune system disease or severe liver failure, renal failure or history
5) Subjects who have systemic diseases such as malignant tumors, lung diseases, leukemia, collagenosis, multiple sclerosis, allergic skin diseases and other autoimmune diseases or history
6) Vaccinated within 3 months before screening
7) Subjects who have uncontrolled high blood pressure(Higher than 160/100mmHg, measured 5 minutes after stabilizing) or Glucose level is above 130
8) Subjects who have a medical history of gastrointestinal diseases(Crohn's disease, etc.) or operation(except appendectomy or herniotomy)
9) Subject who have experienced taking medicines, herbal medicines, and health functional foods that may affect their immune system within two weeks prior to the first intake of the test product (the health functional foods can be participated after a week's recess before the first intake of the clinical product)
10) Subject who get a medical history of psychopharmacotherapy with in last 2 months before screening test
11) Subjects who are suspected drug abuse or have a medical history of dependent on drug
12) Participation in other clinical trials within the previous three months
13) Subject who show the following results in the screening test
? AST, ALT > more than 2 times of the upper limit
? Serum creatinine > 2.0 mg/dL
14) Subjects who are pregnant and breastfeeding female
15) Subject who do not perform adequate contraception in the urban eligible women (except woman who undergo sterilization operation)
16) Subject who deemed inappropriate to participate this clinical trial by research director due to other reasons including screening test

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
K cell activity;Levels of Immune-Related Cytokines

Secondary Outcome Measures

Name	Time	Method
advers event;clinical pathology examination;vital sign(blood pressure, heart rate, body temperature)