KCT0012335进行中（未招募）4 期
A multicenter, randomized, double-blind, placebo-controlled phase IV clinical trial to evaluate the efficacy and safety of Glucom Sol. in subjects with physical fatigue
Korean Drug0 个研究点目标入组 200 人开始时间: 2024年10月4日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
研究概览
简要总结
The fatigue recovery rate in 4 weeks was 86.0% and 70.1% in the treatment and placebo group, respectively, with a statistically significant difference (p < 0.05). In the safety analysis, adverse events were infrequent and mostly mild, and no safety concerns related to Glucom® solution were identified. Conclusion: Glucom® solution significantly improved physical fatigue defined by CIS recovery rate, and no clinically meaningful safety concerns were identified.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 19(Year) 至 No Limit（—）
- 性别
- All
入选标准
- •Adults aged 19 or older
- •Individuals who have experienced persistent fatigue (CIS score of 76 or higher) for at least one month as of the screening date
- •Individuals whose Hospital Anxiety and Depression Scale (HADS) assessment results show Anxiety and Depression scores of 10 or lower each as of the screening date
- •Individuals who have heard the explanation of this clinical trial and have voluntarily consented to participate
排除标准
- •Individuals with hypersensitivity to any component of the investigational medicinal product
- •Individuals with a confirmed history of surgery, medical history, or concomitant diseases among the following:
- •(1) Individuals diagnosed with hepatitis or cirrhosis, or confirmed to have impaired liver function
- •(2) Individuals diagnosed with alcoholism or drug abuse, or psychiatric and neurological diseases (e.g., depression, sleep disorders, anxiety neurosis, schizophrenia, eating disorders, myasthenia gravis, multiple sclerosis, etc.)
- •(3) Individuals suffering from autoimmune diseases (e.g., multiple sclerosis, lupus, rheumatoid arthritis, etc.)
- •(4) Individuals diagnosed with malignant tumors, tuberculosis, asthma, chronic lung disease, glaucoma, hypothyroidism, anemia, cardiovascular disease, or infectious disease
- •(5) Individuals diagnosed with functional or inflammatory gastrointestinal diseases (e.g., irritable bowel syndrome, functional dyspepsia/constipation/diarrhea, Crohn's disease, ulcerative colitis, etc.) who are currently taking related medication or are expected to need to take it during the clinical trial
- •(6) Persons who have undergone surgery within 2 weeks of the screening date
- •Persons with confirmed results of the following tests at the screening date
- •(1) Uncontrolled hypertension (SBP = 170 mmHg, DBP = 100 mmHg)
- •(2) Uncontrolled diabetes (HbA1c = 8.0%)
- •(3) Body mass index (BMI) = 30 kg/?
- •(4) AST, ALT, ALP, or Total bilirubin is 2 times or more the upper limit of normal at the testing facility
- •(5) Creatinine is 2 times or more the upper limit of normal at the testing facility
- •(6) HIV positive (can be substituted if test results are available from within 12 weeks of the screening date)
- •Persons who are taking, using, needing to take, or are expected to take the following fatigue-inducing drugs during the clinical trial period: Beta-blockers, steroids, immunomodulators, antidepressants, anxiolytics, sleeping pills, antihistamines, etc.
- •Those who have received medical or traditional Korean medicine treatment for chronic fatigue, or who have taken medicines or health functional foods that help improve fatigue within 2 weeks of the screening time
- •Those capable of recovering from fatigue in the event of changes in living environment, such as continuous night work or shift work
- •Pregnant or breastfeeding women, or women planning to become pregnant during the clinical trial period, or those who do not consent to the use of medically acceptable contraceptive methods*, and their spouses (or partners)
- •*Medically acceptable contraceptive methods: Copper intrauterine devices (copper loops), condoms, tubal ligation, spermicides, vaginal insertable contraceptives, subcutaneous implants, female condoms, etc.
- •Those who have participated in another clinical trial and received or been administered investigational drugs or medical devices within 12 weeks of the screening time
- •Any person confirmed by the Principal Investigator (or authorized investigator) to have medical findings that make it difficult or unsuitable to perform this clinical trial
研究者
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