CTRI/2023/05/053039尚未招募2 期
A 12-week, randomized, double blind, placebo controlled, parallel design study to evaluate the efficacy and safety of DKB-138 oral intake on muscle strength improvement
Dongkook Pharmaceutical0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Male and female individuals aged from 50 to 70 (inclusive of 50, exclusive of 70)
- •2.BMI 18.5-30.0 kg/m2 (inclusive of 18.5, exclusive of 30.0)
- •3.Participants who meet the handgrip strength standards for the average value of their both hands. (Men: less than 33kg, Women less than 21kg) (exclusive of 33 and 21)
- •4.Participants who do not change their lifestyle (participation in a physical activity program or intake of other health supplements that may affect the study during the intervention.)
- •5.Participants who voluntarily agree to participate and sign the informed consent form.
排除标准
- •1. Participants with allergy to the test product
- •2. Patients with severe lower extremity musculoskeletal anomalies or injuries (Those with spinal cord diseases such as spinal stenosis who have limited gait that requires surgery)
- •3. Those who have undergone surgery within 6 months of the start of the study
- •4. Those who have taken drugs or functional food and that affect muscle strength improvement within 2 weeks from the time of screening (protein powder, amino acid supplement, creatine supplement, Schizandra Chinensis Fruit Extract etc.)
- •5. Those who have participated in an active exercise training program within 3 months of screening.
- •6. Patients with fragile hip joint fractures
- •7. People who cannot talk or walk due to dementia or Parkinsonâ??s disease (those with mild symptoms can participate)
- •8. Those who have been diagnosed with severe cerebrovascular disease (cerebral infraction, cerebral hemorrhage, etc.), heart disease (angina pectoris, myocardial infraction, heart failure, arrhythmia), lung disease (chronic obstructive pulmonary disease, etc.) within 3 months screening (However, those who are clinically stable may participate in the trial at the investigatorâ?? discretion)
- •9. Participants with uncontrolled diabetes mellitus (FBS >126 mg/dI)
- •10. Depression: Those who are taking medications prescribed from Psychiatry and Neurology for a mental disorder (However, if the patient is taking intermittent medication due to sleep disorder, appropriately treated depression is suitable for the study)
- •11. Those with liver disease or those with AST or ALT of 3 times or more of the upper limit of the reference range.
- •12. Those with renal disease or serum creatinine exceeding 2.0 mg/dI.
- •13. Uncontrolled hypertension (blood pressure >= 160/100 mmHg)
- •14. Malignant tumor: Those who have had cancer within 5 years or are currently receiving treatment (except for skin tumors other than melanoma)
- •15. Participants with a psychologically significant medical history or current disease (schizophrenia, epilepsy, anorexia, bulimia, etc.), or a history of alcohol or the other drug abuse
- •16. Those who have taken oral steroids or corticosteroids within 4 weeks of screening.
- •17. Participants who are taking alcohol equal or more than 140g/week
- •18. Pregnant or lactating participants, or women of childbearing age who are do not agree to use contraception (oral contraceptives, hormones, intrauterine devices, condoms, spermicides) during the trial.
- •19. Those who have participated in other study within 3 months of screening.
- •20. Participants who are deemed unable to comply with the test requirements or otherwise deemed unsuitable according to the investigatorâ??s opinion.
研究者
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