KCT0009310招募中未知
A 12-week, Single-center, Randomized, Double-blind, Placebo Controlled Clinical Trial for the Evaluation of the Efficacy and Safety of HUN2-434 on Improving Muscle Strength
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 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
- 50(Year) 至 85(Year)（—）
- 性别
- All
入选标准
- •Those with a BMI of 18.5 kg/m2 or more and 30 kg/m2 or less
- •- Those with grip strength of 28 kg for men and less than 18 kg for women (based on the guidelines for Asian sarcopenia established in 2019) or SARC-F score of 4 or higher
- •- A person who agrees to participate in this human body application test before the human body application test begins and prepares it on the Informed Consent Form
排除标准
- •1) A person currently under treatment for severe cardiovascular, immune, respiratory, gastrointestinal/hepatic and biliary systems, kidney and urinary systems, nervous systems, psychotropic, infectious diseases and malignant tumors (except for skin tumors other than melanoma, those who have recovered from cancer after five years can participate)
- •2) a person with cognitive impairment caused by Parkinson's disease or dementia
- •3) Those with rheumatoid arthritis, other systemic immune diseases, acquired immunodeficiency syndrome (AIDS), etc
- •4) A person who has a vulnerable hip joint, or who is restricted from walking due to stroke, spinal disease, etc
- •5) A person who has a problem with eating food for human application test due to gastrointestinal disorders
- •6) A person who is taking medication in neuropsychiatry due to a psychiatric disorder (but if intermittent administration is due to a sleep disorder, properly treated depression is suitable for registration and only over-the-counter drugs and health functional foods are allowed)
- •7) A person who takes a drug that can affect his or her muscles within 7 days of visiting or has received non-drug treatment (but is allowed intermittently in the case of non-drug treatment such as acupuncture, injection, physical therapy, etc. in the knee and hand, but prohibited within 3 days of visiting)
- •8) Those who have administered systemic steroids (cortisol, etc.) or used hormones (testosterone, estrogen, androgen, growth-related hormones, adrenocorticotropic hormone, etc.) within 4 weeks of visit 1
- •9) A person who has used supplements related to muscle strength improvement (amino acids, creatine, etc.) or health functional foods (including calcium and vitamin D) within two weeks of visiting 1 (however, health functional foods can participate if they are being administered without any change in dose from three months ago)
- •10) A person who consumes 140 g/week (20 degree soju) or more of alcohol (about 2.5 bottles/week, about 2.5 cups/day)
- •11) Those who participated in aerobic or resistance exercise continuously (more than three times a week) within three months of visiting
- •12) A person whose serum BUN is at least twice the upper limit of normal administration
- •13) Those whose AST (GOT) or ALT (GPT) is at least three times the upper limit of the normal administrative agency
- •14) Patients with uncontrolled hypertension (systolic blood pressure of 160 mmHg or diastolic blood pressure of 100 mmHg or more, the standard of measurement after 10 minutes of rest)
- •15) uncontrolled diabetics (abdominal blood sugar above 180 mg/dL)
- •16) Thyroid disease patients with TSH of 0.1 µIU/mL or more than 10 µIU/mL
- •17) Pregnant or nursing mothers or those who plan to become pregnant during the period of this human application test
- •18) Those who have participated in other interventional clinical trials (including human application tests) within three months of visiting 1 or plan to participate in other interventional clinical trials (including human application tests) during the period of this human application test
- •19) Those who are sensitive to or allergic to food ingredients for this human application test
- •20) A person who deems that the tester is unfit for other reasons
研究者
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