CTRI/2024/05/068070尚未招募3 期
A Randomized, Placebo-Controlled, Double-Blind Clinical Study to evaluate the Efficacy and Safety of a Dose for Soreness (Dietary supplement) in reducing Muscle Soreness and improving muscle relaxation in Healthy adults
Eetho Brands1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2024年6月10日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Change from baseline to end of the trial period in Improvement in the stabilization of muscles or a reduction in the degree of muscle fatigue measured by an increase in VO2 max (treadmill)
研究概览
简要总结
This is a Randomized, Placebo-Controlled, Double-Blind Clinical Study to evaluate the Efficacy and Safety of a Dose for Soreness (Dietary supplement) in reducing the Muscle Soreness and improving the muscle relaxation in Healthy adults. subjects shall be administered with either test product or Placebo daily twice for 30 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 19.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or female subjects between 19 to 60 years of age
- •Adult subjects with good health, as determined by a health history and at the Investigators discretion.
- •Subject willing to participate and able to comply with the protocol.
- •Subjects who provide written, signed, and dated informed consent.
排除标准
- •Subjects with a sleep disorder or a history of clinical depression, eating disorders, or other psychiatric conditions.
- •Subjects with a history or current presence of health conditions, including abnormal resting ECG, bleeding disorder, diabetes, high blood pressure, thyroid disease, tachyarrhythmia, heart disease, kidney disease, or liver disease.
- •Participants using medications.
- •anti-inflammatory, analgesic, antioxidant drugs, nutritional products, and dietary supplements that may interfere with the study results, as determined by the investigators opinion.
- •History of allergy or sensitivity to any ingredient in the test product, as well as a history of alcohol or other drug abuse within the last year.
- •Participation in another clinical study within the past 30 days.
- •Subjects with a history of orthopaedic injury or surgery within the last year.
- •Presence of any physical condition considered a contraindication to the type of exercise to be performed in the study.
- •Subjects who do not agree to participate or are not capable of complying with protocol requirements.
- •Women who are pregnant or breastfeeding.
结局指标
主要结局
Change from baseline to end of the trial period in Improvement in the stabilization of muscles or a reduction in the degree of muscle fatigue measured by an increase in VO2 max (treadmill)
时间窗: Baseline (Day 0), Day 15 and Day 30
次要结局
- Change from baseline to end of the trial period in Decrease in levels of Creatine Kinase (CK) assessed by the oxidative stress and inflammatory marker test (Hs CRP)(Baseline (Day 0), Day 15 and Day 30)
- Change from baseline to end of the trial period in Reduction in pain score, identified using the Visual Analog Scale (VAS).(Baseline (Day 0), Day 15 and Day 30)
- Change from baseline to end of the trial period in Global assessment of overall improvement from baseline to end of the study (SGA and PGA)(Baseline (Day 0), Day 15 and Day 30)
- Change in the levels of C-reactive protein from baseline to end of the study(Baseline (Day 0), Day 15 and Day 30)
- Change in vital sign parameters from baseline to end of the study(Baseline (Day 0), Day 15 and Day 30)
- Change in laboratory safety parameters (haematological parameters, liver function, kidney function and blood lipid profile parameters) from baseline to end of the study.(Screening and EOT)
- Incidence of adverse events during study period(Day 15 and Day 30)
- SF 36 – QOL – Vitality scale(Baseline (Day 0), Day 15 and Day 30)
研究者
Dr Deepak Mishra MD(General Medicine)
Shivnath Hospital
研究点 (1)
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