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CTRI Number  CTRI/2026/02/104343 [Registered on: 19/02/2026] Trial Registered Prospectively
Last Modified On: 17/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of Ayurveda medicines on borderline intelligence in children. 
Scientific Title of Study   Randomized comparative controlled clinical study on the efficacy of intel up gummies on borderline intelligence on fifth standard students 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Preeti prasad 
Designation  Post graduate scholar 
Affiliation  Parul Institute of Ayurved and Research 
Address  Department of Kaumarabhritya, Parul Institute of Ayurved and Research, Parul University

Vadodara
GUJARAT
391760
India 
Phone  8766921328  
Fax    
Email  preetiprasad1920@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Arun Raj GR 
Designation  Professor and head of department 
Affiliation  Parul Institute of Ayurved and Research 
Address  Department of Kaumarabhritya, Parul Institute of Ayurved and Research , Parul University, Vadodara

Vadodara
GUJARAT
391760
India 
Phone  9886292826  
Fax    
Email  drdrarunraj26@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Arun Raj GR  
Designation  Professor and head of department 
Affiliation  Parul Institute of Ayurved and Research 
Address  Department of Kaumarabhritya, Parul Institute of Ayurved and Research , Parul University, Vadodara

Vadodara
GUJARAT
391760
India 
Phone  9886292826  
Fax    
Email  drdrarunraj26@gmail.com  
 
Source of Monetary or Material Support  
Dr Preeti Laxman Prasad , Post Graduate Scholar , Department of Kaumarabhritya, Parul Institute of Ayurved and Research , Parul University , P.O Limda, Vadodara, Gujarat - 391760, India 
 
Primary Sponsor  
Name  Dr Preeti Prasad  
Address  Post graduate scholar, Department of Kaumarabhritya, Parul Institute of Ayurved and Research , Parul University , P.O.Limda, Vadodara, Gujarat- 391760, India 
Type of Sponsor  Other [[self]] 
 
Details of Secondary Sponsor  
Name  Address 
Nil  Nil 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Preeti Laxman Prasad  khemdas Hospital   OPD no 6, Ground floor, Parul Institute of Ayurved and Research, Parul University , Vadodara - 391760, Gujarat.
Vadodara
GUJARAT 		 8766921328

preetiprasad1920@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
PIAR-IECHR  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:F70-F79||Intellectual disabilities. Ayurveda Condition: BUDDHIMANDYAM (KEVALA-KAPHA), (2) ICD-10 Condition:F70||Mild intellectual disabilities. Ayurveda Condition: BUDDHIMANDYAM (KEVALA-KAPHA),  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther than Classical(1) Medicine Name: intel up gummies, Reference: NA, Route: Oral, Dosage Form: Lozenges, Dose: 2(NA), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: -
2Comparator ArmDrugOther than Classical(1) Medicine Name: Brahmi gummies, Reference: NA, Route: Oral, Dosage Form: Lozenges, Dose: 2(NA), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  10.00 Year(s)
Age To  11.00 Year(s)
Gender  Both 
Details  Age group 10-11 years.
Children with intelligence quotient 63-74 using BINET KAMAT SCALE .
Children of either gender, irrespective of caste , religion, and socioeconomic status will be taken .
Children enrolled in regular school.
Able to understand and respond to basic verbal instructions.
Parent consent obtained. 
 
ExclusionCriteria 
Details  Children diagnosed with moderate, severe, or profound intellectual disability .
Children with known psychiatric, neurological or sensory impairments 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To evaluate the effect of Intel Up Gummies by improving intelligent quotient in children.  Assessment of intelligence quotient using Binet Kamat Test of Intelligence scale on baseline and 90 th day 
 
Secondary Outcome  
Outcome  TimePoints 
To assess memory power   Assessment of memory power using PGI memory scale on baseline and 90th day.  
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   28/06/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [preetiprasad1920@gmail.com].

  6. For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
    Response (Others) -  One year post publication of research paper

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This clinical trial is a double blind comparative controlled study to evaluate the efficacy of intel up gummies and brahmi gummies in children with borderline intelligence IQ( 63-74). The study focuses on 5th standard students aged 10-11 years and aims to assess the impact of these ayurvedic formulation on intelligence quotient, memory and academic performance. Conducted as an double blind , double arm randomized clinical trial, the study includes children with IQs between 63-74 , determined using Binet Kamat Test of Intelligence (BKT scale). Participants with neurobehavioral disorders ( such as AHD and Autism ) , chronic illnesses, congenital abnormalities, or severe mental retardation are excluded. The intervention consists of two groups receiving either intelup gummies and brahmi gummies with the dosage of 4 gms after food twice daily for a period of 90 days . The study evaluates outcomes through IQ assessment using Binet Kamat scale, memory assessment with PGI memory scale for Children and academic performance. By comparing these ayurvedic formulations, the trial aims to determine the efficacy in improving intelligence, memory and concentration in children with borderline intelligence . 
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