KCT0005707尚未招募未知
A 12 weeks, randomized, double-blinded, placebo-controlled study of KBH-HM01 to evaluate efficacy and safety on immune function
KolmarBNH0 个研究点目标入组 100 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 45(Year) 至 70(Year)（—）
- 性别
- All
入选标准
- •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.)
排除标准
- •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.
- •9. Took other investigational product or participated clinical trial medicines within the last 3 months
- •10. Surgical surgery within the last 6 months or receiving prohibited treatment within 4 weeks (medical food for enhanced immunity, herbal medicine, or medication for possible abuse).
- •11. Surgery that may affect the absorption of drugs, such as gastrointestinal dysfunction or gastrointestinal resection.
- •12. Thyroid disease (hypothyroid or hormonal abnormalities/hypothyroidism).
- •13. Neurological and mental disorders (depression, schizophrenia) and psychotherapy.
- •14. Surgery (including childbirth) or cancer patients within the last 6 months.
- •15. Drug addicts and subjects who have taken vaccine, immunosuppressants, nonsteroidal anti-inflammatory drugs, steroids, and antihistamines within the last 3 months.
- •16. Fertile woman who disagrees with the choice of pregnant women, breastfeeding women and appropriate contraceptive methods (oral contraceptives, hormone transplants, intrauterine instruments, condoms, and spermicide).
- •17. Immunosuppressive drugs or other immuno-improvement functional foods within the last 4 weeks.
- •18. Donated whole blood within the last 2 months or donated blood components within 4 weeks.
- •19. Taken antibiotics for more than 7 days.
- •20. Judged by the investigators to be inappropriate for the clinical trial
研究者
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