KCT0005707
Not yet recruiting
未知
A 12 weeks, randomized, double-blinded, placebo-controlled study of KBH-HM01 to evaluate efficacy and safety on immune function
KolmarBNH0 sites100 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- KolmarBNH
- Enrollment
- 100
- Status
- Not yet recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Male or female subjects aged from 45 to 70 years old.
- •2\. Subjects who signed written informed consent voluntarily.
- •3\. white blood cell (WBC) ranged from 4,000 to 6,000/µl.
- •4\. Subjects suffered from upper respiratory tract infection or cold\-related symptoms which have possibilities to cause upper respiratory tract infection more than two times in the past one year. (\*Tonsillitis, pharyngitis, laryngitis, sinusitis, otitis media, rhinitis, etc.)
Exclusion Criteria
- •1\. History or presence of sensitivity or allergic to drugs or functional food including Angelica gigas Nakai,Cnidium officinale Makino,Paeonia lactiflora Pallas
- •2\. Immune\-related diseases, such as liver diseases including active hepatitis, leukemia, inflammatory systemic diseases, metabolic syndrome, infectious diseases, autoimmune diseases, etc.
- •3\. Dementia, brain tumors, hydrocephalus, or who have conducted or are undergoing hormone replacement therapy within the last 4 weeks.
- •4\. Stroke, heart disease (cardiac failure, arrhythmia, myocardial infarction, using implantable defibrillator), malignant tumor, angle close glaucoma, uncontrolled hypertension (SBP 140mmHg or higher or DBP 90mmHg or higher), lung disease, respiratory disease.
- •5\. Serum creatinine\> 2\.0 mg/dl, AST (aspartate aminotransferase) or ALT (alanine aminotransferase) is more than 2\.5 times the normal upper limit.
- •6\. Insulin injection, FBS (fasting blood sugar) level is greater than 160 mg/dl even taking drugs to control blood sugar.
- •7\. Any of the following below
- •a) Platelet \=100\*103
- •b) WBC 4,000\-10,000/ul
- •8\. Taking oral steroids, hormones, etc. within the last 4 weeks or has taken drugs that affect the absorption, metabolism, and excretion of investigational product.
Outcomes
Primary Outcomes
Not specified
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