A Prospective Comparative Placebo controlled clinical study to evaluate the efficacy and safety of Zincovit ACTIVE Instant Rehydration Solution in Fatigue/Stress
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- 1. Acute treatment effects on subjective arousal/stress/fatigue ratings as assessed by visual analogue scales during follow ups
研究概览
简要总结
The study will include 80 study subjects suffering from fatigue due to fever, dehydration and tiredness after excessive physical activity or during surgery post OP care, will be recruited and screened as per the inclusion criteria.
Primary end Points
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Acute treatment effects on subjective arousal/ stress/ fatigue ratings as assessed by visual analogue scales during follow ups (Time frame: 0 min, 15 min, 30 min, 1 hr, 2 hr, 6hr, 12 hr, 24 hr and 48 hr and post study)
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Subjective ratings of arousal (0 min, 15 min, 30 min, 1 hr, 2hr, 6hr, 12 hr, 24hr and 48 hr and post study)
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Changes in the electrolyte levels
-
Reduction in overall fatigue as measure by Fatigue Severity scale
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Convalescence time will be monitored
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Study Subjective cognitivr assessment will be monitored ((pre and post study)
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Clinical Assessment of study subjects hydration status based on presenting symptoms
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Study IRS intake
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Study Subject Satisfaction questionnaire
Secondary Outcomes
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Study Subjects and Investigator feedbacks and quality of life
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Medically confirmed adverse events collected throughout the period
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Record study subject use of antibiotics and other drugs
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Safety and tolerability evaluation criteria
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects, aged 18 years and above.
- •Subjects suffering from fatigue due to fever, post operative period, dehydration and tiredness after excessive physical activity.
- •Measurable fatigue, defined as a score of ≥ 10 on the fatigue severity scale.
排除标准
- •Severe dehydration and/or use of IV fluids for current hospitalization 2) Experiencing bloody diarrhea or diarrhea due to cholera, dysentery, persistent/chronic diarrhea, diarrhea with severe malnutrition, diarrhea associated with recent antibiotic use 3) In the opinion of the investigator, not suitable for treatment with IRS 4) Have any underlying disease or disorder that may, in the opinion of the investigator, affect the results of the study if they were enrolled (includes, but is not limited to, renal disease, gastrointestinal disorders such as Crohn's disease or other inflammatory bowel disease or congenital malabsorption disorders) 5)Known to be allergic to any of the components of the investigational product 6)Pregnant or lactating Women 7)Uncontrolled type 2 Diabetes mellitus (HbA1c>10).
- •A history of neurological or psychiatric diseases 9)Alcohol or substance abuse 10)Subjects taking any nutritional supplements.
结局指标
主要结局
1. Acute treatment effects on subjective arousal/stress/fatigue ratings as assessed by visual analogue scales during follow ups
时间窗: Baseline, 24 hrs, 48 hrs and 7 days
2. Subjective ratings of arousal (concentration, mental stamina/physical stamina) stress and fatigue (mentally tired/physically tired) visual analogue scales
时间窗: Baseline, 24 hrs, 48 hrs and 7 days
3. Changes in the electrolyte levels
时间窗: Baseline, 24 hrs, 48 hrs and 7 days
4. Reduction in overall fatigue as measured by Fatigue Severity Scale
时间窗: Baseline, 24 hrs, 48 hrs and 7 days
5. Convalescence time and cognitive assessment will be done
时间窗: Baseline, 24 hrs, 48 hrs and 7 days
6. Study IRS intake
时间窗: Baseline, 24 hrs, 48 hrs and 7 days
次要结局
- 1. Study Subject & investigator feedbacks & quality of life will be assessed(2. Medically confirmed adverse events collected throughout the study period)
研究者
Dr Vinoth
Mahatma Gandhi Medical College & Research Institute