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Clinical Trials/CTRI/2018/05/014267
CTRI/2018/05/014267CompletedPhase 1

A Study of Medhya Activity of Vachadi Ghrita on Learning And Memory of High School Children.

Dept of Rasashastra and Bhaishajya Kalpana Bharati Vidyapeeth Deemed University College of Ayurved1 site in 1 country90 target enrollmentStarted: June 7, 2015Last updated:

Trial Snapshot

Phase
Phase 1
Status
Completed
Sponsor
Enrollment
90
Locations
1
Primary Endpoint
1.Increase in z-score of ‘Test of Higher Mental Ability in Science’ will indicate improvement in Higher Mental Ability in science in 30 days.

Study Overview

Brief Summary

This study is Non-randomized, placebo Active Controlledtrial. Studyfocuses on Effect Of Medicated Ghee on enhancement of memory. Thisstudy consists of 3 groups of 30 students each. Beforeadministration of ghee pre assessment learning and memory tests are carried outon day 0 for all 3 groups. From day 1st to day 30 th Medicated gheeis administered to Group A (Study Group), Cow ghee is administered to Group B (ActiveControl Group) and no ghee is given to group C(Plain Control). On day 31st postassessment learning and memory tests are taken. Primary outcome measures willbe Increase in z-score of ‘Test of Higher Mental Ability in Science’ and that willindicate improvement in Higher Mental Ability, Increase in Numerical Ability Quotient (NAQ) of ‘Numerical AbilityTest’ will indicate improvement in Numerical ability. Total study duration is of 32days.

Study Design

Study Type
Interventional
Allocation
Not Applicable
Masking
Not Applicable

Eligibility Criteria

Ages
10.00 Year(s) to 16.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • 1.Healthy subjects of either sex 2.Subjects attending school regularly and willing to take part in the project 3.Age group 10-16 years 4.Students of matching socio-economic class.

Exclusion Criteria

  • 1.Subjects not attending school 2.Subjects attending school but not willing to take part in the project.
  • 3.Subjects with any physical and or psychological disorders.
  • 4.Students having learning disabilities, and learning disorders.

Outcomes

Primary Outcomes

1.Increase in z-score of ‘Test of Higher Mental Ability in Science’ will indicate improvement in Higher Mental Ability in science in 30 days.

Time Frame: 1.Increase in z-score of ‘Test of Higher Mental Ability in Science’ will indicate improvement in Higher Mental Ability in science in 30 days. | 2.Increase in Numerical Ability Quotient (NAQ) of ‘Numerical Ability Test’ will indicate improvement in Numerical ability.

2.Increase in Numerical Ability Quotient (NAQ) of ‘Numerical Ability Test’ will indicate improvement in Numerical ability.

Time Frame: 1.Increase in z-score of ‘Test of Higher Mental Ability in Science’ will indicate improvement in Higher Mental Ability in science in 30 days. | 2.Increase in Numerical Ability Quotient (NAQ) of ‘Numerical Ability Test’ will indicate improvement in Numerical ability.

Secondary Outcomes

  • 1.Change in Weight(2.Change in appetite)

Investigators

Sponsor
Dept of Rasashastra and Bhaishajya Kalpana Bharati Vidyapeeth Deemed University College of Ayurved
Sponsor Class
Private medical college

Study Sites (1)

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