KCT0012357进行中（未招募）不适用
A Human Clinical Trial on the Fatigue Improvement of L-Arginine; A Randomized, Double-Blind, Placebo-Controlled Pivotal Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 120
研究概览
简要总结
Based on the efficacy evaluation after 8 weeks of L-Arginine intake using the PP Set and FA Set, improvements were observed in the primary efficacy endpoint as well as major fatigue-related efficacy parameters compared with the control group. Therefore, L-Arginine was determined to be helpful in improving fatigue.
研究设计
- 研究类型
- Interventional
- 主要目的
- Other(The objective of this human clinical trial is to verify the functionality of L-Arginine as a health functional food ingredient by evaluating its efficacy and safety regarding fatigue improvement upon), Intervention Model : Parallel, Blinding/Masking : Double, Blinding Target : Subject, Investigator, Allocation : RCT
入排标准
- 年龄范围
- 30(Year) 至 59(Year)（—）
- 性别
- All
入选标准
- •Adult males and females aged 30 to under 60 years who experience usual fatigue.
- •Individuals with mild fatigue (Fatigue Severity Scale [FSS] total score of 27 or higher).
- •Individuals whose maximal oxygen uptake (VO2max) is within the range between the top 15% and the bottom 25% (Excluding those who exceed the top 15% and those who fall below the bottom 25%, based on the Korean physical fitness percentile data of the National Fitness Award 100 project).
排除标准
- •Medication Use
- •Individuals diagnosed with drug addiction by a physician.
- •Individuals with a history of alcohol and other drug abuse within 1 year prior to screening.
- •Individuals who have continuously consumed health functional foods or products that may affect exercise performance or fatigue (fitness supplements, fatigue recovery products, complex health functional foods containing vitamin C, vitamin B complex, magnesium, potassium, calcium, etc.) within 1 month prior to the first visit.
- •Disease Status
- •Liver disease: Individuals with a liver disease requiring treatment, or with AST or ALT levels 3 times or more the upper limit of normal (ULN), or Serum Bilirubin levels 2 times or more the ULN.
- •Individuals with eGFR < 60 mL/min/1.73 m
- •Uncontrolled diabetes at screening (i.e., HbA1c > 7.0 %).
- •Individuals with hypotension (SBP < 90 mmHg or DBP < 60 mmHg).
- •Hypertension: Uncontrolled hypertension (SBP > 140 mmHg or DBP > 90 mmHg).
- •Individuals with a history of malignant tumors within the past 5 years.
- •Individuals with tuberculosis, multiple sclerosis, hypothyroidism, or asthma uncontrolled by medication.
- •Individuals with a diagnosed history of major depressive disorder, bipolar affective disorder, schizophrenia, dementia, delusional disorder, or insomnia.
- •Individuals with a Body Mass Index (BMI) of 18.5 kg/m2 or less, or 35.0 kg/m2 or more.
- •Other General Factors (Physiological, Lifestyle, Allergic Reactions, etc.)
- •Night shift workers.
- •Individuals unable to perform treadmill exercises.
- •Women who are pregnant, breastfeeding, or planning to become pregnant during this human clinical trial period.
- •Excessive alcohol consumption (Men: 40 g or more per day, Women: 20 g or more per day).
- •Heavy smokers (20 or more cigarettes/day).
- •Individuals who have continuously engaged in high-intensity exercise or higher within 3 months prior to the first visit.
- •Individuals with excessive usual protein intake (those who have continuously consumed protein supplements, eggs, milk, etc., for the purpose of protein intake other than regular meals for more than 1 month), or vegetarians.
- •Individuals with known allergies/adverse reactions to the test substance.
- •If arrhythmia findings, such as 2mm ST-segment depression, asystole, threshold limit of 3 seconds, ventricular fibrillation/flutter, ventricular tachycardia, premature ventricular contractions (minimum of 3 consecutive PVCs), or ventricular couplets (2 consecutive PVCs), are observed during the exercise stress test electrocardiogram (ECG), eligibility will be determined based on the judgment of a specialist or the principal investigator.
- •Individuals deemed unsuitable for the human clinical trial by the principal investigator (e.g., if the clinician determines a causal relationship with a disease through the medical interview).
研究者
相似试验
尚未招募
2 期
Effect of Add-on L-Arginine Therapy on Heart Failure PatientsHeart FailureNCT07394270German University in Cairo200
招募中
Unknown
A Study Comparing the Effectiveness of Myo Fatige Forte Supplementation and Physiotherapy in Managing Chronic Lower Back PainCTRI/2025/09/095498Fourrts (India) Laboratories Pvt.Limited150
招募中
4 期
Randomized, placebo-controlled, double-blind study to evaluate the efficacy of 2LEBV® and 2LXFS® on asthenia in patients with an EBV infection2024-514222-24-00Labo'Life Belgium, Labo'Life Belgium88
已完成
不适用
Effect of Korean Ginseng Extract on FatigueNCT07590713University of Taipei60
尚未招募
不适用
Impact of Fatigue Awareness and Exercise Program on Fatigue and Quality of Life in Family Caregivers of Children with Cerebral Palsy.CTRI/2026/01/101201Maharashtra Institute of Physiotherapy, Latur48