Effect of Zincovit ACTIVE Instant Rehydration Solution in fatigue and stress
- Conditions
- Health Condition 1: R538- Other malaise and fatigue
- Registration Number
- CTRI/2024/05/067877
- Lead Sponsor
- Apex Laboratories Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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
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).
8)A history of neurological or psychiatric diseases
9)Alcohol or substance abuse
10)Subjects taking any nutritional supplements.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Acute treatment effects on subjective arousal/stress/fatigue ratings as assessed by visual analogue scales during follow ups <br/ ><br>2. Subjective ratings of arousal (concentration, mental stamina/physical stamina) stress and fatigue (mentally tired/physically tired) visual analogue scales <br/ ><br>3. Changes in the electrolyte levels <br/ ><br>4. Reduction in overall fatigue as measured by Fatigue Severity Scale <br/ ><br>5. Convalescence time and cognitive assessment will be done <br/ ><br>6. Study IRS intakeTimepoint: Baseline, 24 hrs, 48 hrs and 7 days
- Secondary Outcome Measures
Name Time Method 1. Study Subject & investigator feedbacks & quality of life will be assessed <br/ ><br>2. Medically confirmed adverse events collected throughout the study period <br/ ><br>3. Record study subject use of antibiotics & other drugs during hospitalizationTimepoint: Baseline, 24 hrs, 48 hrs & 7 days