CTRI/2017/11/010493已完成3 期
Randomized, Single centric, single arm, open label study to evaluate the efficacy and safety of Nutricharge Gainer with Nutricharge Prodiet on improved muscle mass along with increased energy levels
Trophic Wellness Pvt Ltd0 个研究点目标入组 50 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
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 subjects between 18-60 years of age
- •2.Subjects able to communicate effectively.
- •3.Subjects willing to provide written informed consent
- •4.In the judgment of the Principal Investigator, able to comply with protocol requirements.
- •5.Ability to schedule and attend monthly visits for the duration of the study.
- •6.Agree to do physical activities as stated in the protocol
- •7.Subject agrees not to start any new supplement which would affect body composition during the course of the study
排除标准
- •1.Contraindications or Hypersensitivity to study product.
- •2.History or presence of any medical condition or disease according to the discretion of the Investigator.
- •3.No contraindications to exercise as outlined by the American College of Sports Medicine (ACSM).
- •4.Use of nutritional supplements known to improve energy and muscle strength and/or muscle mass within seven weeks prior to the start of the study.
- •5.All medications that can interfere with muscle mass such as corticosteroids (e.g. Prednisone), testosterone replacement or anabolic drugs.
- •6.Subjects who are under herbal supplements within seven (7) days prior to screening.
- •7.Subjects using any other therapies that would affect body composition other than those revealed during recruitment process.
- •8.Subjects having history of asthma.
- •9.Subjects having history of cardiovascular diseases.
- •10.Subjects having history of diabetes (Type I or Type II) except other than the subject having the pre-diabetes condition with the fasting blood glucose between 100 to 125 mg/dl or random blood glucose > 140-199 mg/dl.
- •11.Subjects having BP above 180/100 or below 80/50 mmHg
- •12.Subjects having thyroid disease.
- •13.Subjects having abnormal liver or kidney function tests (ALT or AST 2 times the upper limit of normal; elevated Creatinine, males 125 μmol/L,).
- •14.Subjects having abnormal findings on complete blood count
- •15.Subjects with HIV Positive.
- •16.Subjects having history of high alcohol intake (2 standard drinks per day).
- •17.Subjects having history of psychiatric disorder that may impair the ability of subjects to provide written informed consent.
- •18.Any other condition that, in the opinion of the investigator, would adversely affect the subjectâ??s ability to complete the study or its measures.
- •19.Subjects participated in any clinical study within thirty (30) days prior to screening.
研究者
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