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Clinical Trials/KCT0005707
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.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
5 years ago
Study Type
Interventional Study
Sex
All

Investigators

Sponsor
KolmarBNH

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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