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Clinical Trials/CTRI/2024/05/067877
CTRI/2024/05/067877Not yet recruitingPhase 3

A Prospective Comparative Placebo controlled clinical study to evaluate the efficacy and safety of Zincovit ACTIVE Instant Rehydration Solution in Fatigue/Stress - Nil

Apex Laboratories Private Limited0 sites0 target enrollmentStarted: TBDLast updated:
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Trial Snapshot

Phase
Phase 3
Status
Not yet recruiting
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional

Eligibility Criteria

Inclusion Criteria

  • •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

Exclusion Criteria

  • •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.

Investigators

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