Efficacy of Intel-Up Gummies in Children with Borderline Intellectual Functioning: A Randomized Controlled Open-Label Comparative Clinical Trial Protocol
*1Preeti L Prasad, 2Arun Raj GR and 3Mokindan R
1-3Department of Kaumarabhritya, Parul Institute of Ayurved and Research, Vadodara - 391760 (India) Corresponding Author: *Dr. Preeti L Prasad, PG Scholar, Ph no.: 87 66921328 Email: preetiprasad1920@gmail.com
ABSTRACT
Background: Borderline intellectual functioning (BIF) represents a clinically significant yet under-recognized cognitive state characterized by subaverage intellectual performance that does not meet the criteria for intellectual disability. Children within this range frequently exhibit academic difficulties, reduced cognitive efficiency, and impaired adaptive functioning, yet often remain outside the scope of structured therapeutic interventions. Current management is largely supportive and does not directly target cognitive enhancement, highlighting a need for safe and effective therapeutic options. Objective: To evaluate and compare the efficacy of Intel-Up Gummies, a polyherbal Medhya Rasayana formulation, with Brahmi Gummies in improving intelligence and memory among children with borderline intellectual functioning. Methods: This randomized, controlled, open-label, parallel-group comparative clinical trial will include 90 children aged 10–11 years with IQ scores between 63–74 assessed using the Binet–Kamat Test. Participants will be randomly allocated into two groups (n=45 each). Group A will receive Intel-Up Gummies, and Group B will receive Brahmi Gummies for a duration of 90 days. The primary outcome will be change in intelligence quotient, while secondary outcomes include memory performance and academic parameters. Expected Outcomes: The study is expected to demonstrate improvement in cognitive functions in both groups, with potential additional benefits in the polyherbal formulation group. Conclusion: This study aims to generate clinical evidence for the use of Medhya Rasayana in cognitive enhancement and may contribute to the development of practical and accessible therapeutic strategies for children with borderline intellectual functioning.