A prospective, open label, comparative, case study to evaluate the efficacy and safety of immediate release bioenhanced curcuminoids (Zing95) in muscle soreness.
概览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- MAKAMS Industries Private Limited
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- The change in muscle pain on VAS
概览
简要总结
This study will enroll 24 healthy volunteers aged 21–35 years who engage in moderate physical activity and develop muscle soreness after gym-based exercise. Eligible participants will be trained individuals who have not exercised in the past two months and have no musculoskeletal pathology. The study will evaluate the efficacy and safety of Zing95 curcuminoids through multiple parameters, including changes in muscle pain, tenderness, swelling, jump performance, fatigue, lean body mass, creatine kinase, CRP, LDH, VO 2 max, and endurance. Assessments will be conducted from baseline through Day 7, with additional evaluation of paracetamol or NSAID use, tolerability, satisfaction, and adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 21.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- All
入选标准
- •Healthy human volunteers aged between 21 years to 35 years
- •The study will include trained candidates who have not performed any exercise in the last 2 months.
- •Participants with no known musculoskeletal pathology
- •Participants willing to sign informed consent and to undergo all the study procedure.
排除标准
- •Participants using systemic corticosteroids within 2 months of screening
- •Participants with any other investigational drug within 1 month prior to randomization;
- •Participants with uncontrolled diabetes mellitus and hypertension
- •Participants with known tuberculosis, HIV, ischemic heart disease, cancer, kidney failure
- •Pregnant and lactating women
- •Participants with significant abnormal laboratory parameters
- •Known hypersensitivity to any of the ingredients of test product
- •Other conditions, which in the opinion of the investigators, makes the participant unsuitable for enrolment or could interfere with his/her participation in, and completion of the protocol.
结局指标
主要结局
The change in muscle pain on VAS
时间窗: Day 0 (baseline), Day 1, Day 3, Day 5(Telephonic Discussion) and Day 7.
The change in muscle tenderness by VAS tenderness on palpation
时间窗: Day 0 (baseline), Day 1, Day 3, Day 5(Telephonic Discussion) and Day 7.
Assessment of change in muscle swelling
时间窗: Day 0 (baseline), Day 1, Day 3, Day 5(Telephonic Discussion) and Day 7.
Assessment of change in jump performance
时间窗: Day 0 (baseline), Day 1, Day 3, Day 5(Telephonic Discussion) and Day 7.
Power output
时间窗: Day 0 (baseline), Day 1, Day 3, Day 5(Telephonic Discussion) and Day 7.
To evaluate the reduction in tiredness and fatigue measured with Chalder Fatigue Scale
时间窗: Day 0 (baseline), Day 1, Day 3, Day 5(Telephonic Discussion) and Day 7.
Assessment of Delayed Onset Muscle Soreness will be conducted
时间窗: Day 0 (baseline), Day 1, Day 3, Day 5(Telephonic Discussion) and Day 7.
To measure change in Lean Body Mass (LBM) and Muscle Mass by CULT Smart Scale PRO
时间窗: Day 0 (baseline), Day 1, Day 3, Day 5(Telephonic Discussion) and Day 7.
次要结局
- Assessment of change in Creatinine Kinase ,CRP , LDH after 1 hours of exercise.(To evaluate the improvement in energy levels by measuring VO2 max through Downhill Treadmill test)
研究者
Dr R M Muthiah MBBS MD
Ki3 PRIVATE LIMITED