CTRI/2019/05/019406尚未招募2 期
Parallel arm, clinical study to evaluate the Effectiveness, Safety and Tolerability of energy drink NE-S01 in improving wellbeing, exercise efficacy and stamina in healthy and diabetic individuals. - Nil
aturedge Beverages Pvt Ltd0 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.Subject of age 18 to 60 years has a B.W in between 45 to 75 kg.
- •2. Subject is a non-smoker.
- •3. Subject is in good health and appropriate for exercise.
- •4.Subjects with diabetes mellitus type 2 with fasting blood sugar between 120-180 mg/dl with or without ongoing oral hypoglycemic agents
- •5.Subject agrees to not use any new vitamins and/or minerals until after study completion and to not take any vitamins and/or minerals 24 hours prior to the test visits.
- •6.Subject agrees to not use any dietary or herbal supplements until after study completion. A 7-day washout is allowed for study inclusion.
- •7.Subject is willing and able to comply with the protocol including: Attending 3 visits; Refraining from caffeine, over-the-counter medications and alcohol for the 24 hours prior to the test visits; Refraining from taking any dietary or herbal supplements throughout the study.
- •8. Subject is able to understand and sign the informed consent to participate in the study.
排除标准
- •The subjects will be excluded based on the following criteria during screening and during the study.
- •1. Subjects with or prior history or presence of clinically significant Cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, musculoskeletal, neurological or psychiatric disease.
- •2. Subject has any orthopedic problem(s) or history of musculoskeletal injury(ies).
- •3. Subject has a history of cancer (except localized skin cancer without metastases) within 5 years prior to screening.
- •4. No prescription or chronic medication use allowed without PI discretion.
- •5. Subject has an allergy to any of the ingredients in the test product.
- •6. Subject is currently taking and unwilling to refrain from taking any over-the-counter stimulant medications/ supplements; seven-day washout required for study inclusion.
- •7. Subject is currently taking and unwilling to refrain from taking any over-the-counter allergy or asthma medication containing pseudoephedrine or ephedrine; seven-day washout required for study inclusion. 8. Subject reports being a regular caffeine consumer defined as consuming > 600 mg of caffeine per day. 9. Subject has a clinically relevant abnormality as defined by the PI or interpreting physician with respect to the physical examination.
- •10. Subject has a history of drug or alcohol abuse in the past 12 months.
- •11. Subject has any condition or abnormality that, in the opinion of the investigator, would compromise the safety of the subject or the quality of the study data.
- •12. Subject with type 1 diabetes
- •13. Subjects receiving insulin
研究者
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