CTRI/2024/05/067877尚未招募3 期
A Prospective Comparative Placebo controlled clinical study to evaluate the efficacy and safety of Zincovit ACTIVE Instant Rehydration Solution in Fatigue/Stress - Nil
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
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) Subjects, aged 18 years and above.
- •2) Subjects suffering from fatigue due to fever, post operative period, dehydration and
- •tiredness after excessive physical activity.
- •3) Measurable fatigue, defined as a score of = 10 on the fatigue severity scale
排除标准
- •1)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
- •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).
- •8)A history of neurological or psychiatric diseases
- •9)Alcohol or substance abuse
- •10)Subjects taking any nutritional supplements.
研究者
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