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CTRI Number  CTRI/2024/06/068254 [Registered on: 03/06/2024] Trial Registered Prospectively
Last Modified On: 03/06/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Study to evaluate effect of ten-on-ten syrup in children with Attention Deficit Hyperactivity Disorder (ADHD) 
Scientific Title of Study   A prospective, interventional, randomised, two-arm, single centre study to evaluate the effect of ten-on-ten syrup on children with attention deficit hyperactivity disorder (ADHD). 
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 Omkar Hajirnis 
Designation  Consultant Paediatric Neurologist 
Affiliation  Bhaktivedanta Hospital and Research Institute  
Address  OPD no 06,First floor, Srishti Complex, Bhaktivedanta Swami Marg, Mira road east, Thane,401107, Maharashtra, India.

Thane
MAHARASHTRA
401107
India 
Phone  9869271683  
Fax    
Email  dr.omkar@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Omkar Hajirnis 
Designation  Consultant Paediatric Neurologist 
Affiliation  Bhaktivedanta Hospital and Research Institute  
Address  OPD no 06,First floor, Srishti Complex, Bhaktivedanta Swami Marg, Mira road east, Thane,401107, Maharashtra, India.

Thane
MAHARASHTRA
401107
India 
Phone  9869271683  
Fax    
Email  dr.omkar@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Omkar Hajirnis 
Designation  Consultant Paediatric Neurologist 
Affiliation  Bhaktivedanta Hospital and Research Institute  
Address  OPD no 06,First floor, Srishti Complex, Bhaktivedanta Swami Marg, Mira road east, Thane,401107, Maharashtra, India.

Thane
MAHARASHTRA
401107
India 
Phone  9869271683  
Fax    
Email  dr.omkar@gmail.com  
 
Source of Monetary or Material Support  
Herba Neuva Implex Private Limited 49/2339, Gandhinagar, Bandra East, Mumbai, Maharashtra, India 400051 
 
Primary Sponsor  
Name  Herba Neuva Implex Pvt. Ltd 
Address  49/2339, Gandhinagar, Bandra East, Mumbai 400051 
Type of Sponsor  Pharmaceutical industry-Global 
 
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 Omkar Hajirnis  Bhaktivedanta Hospital and Research Institute   OPD No. 06, First Floor,Bhaktivedanta Swami Marg, Sector 6, Sector 1, Srishti Complex, Mira Road East, Thane, Maharashtra, India 401107
Thane
MAHARASHTRA 
9869271683

dr.omkar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
BhaktiVedanta Hospital Ethics Committee for Biomedical and Health Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F90||Attention-deficit hyperactivity disorders,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Standard of care (control group)  Occupational therapy/behavioural therapy and/or medication (Stimulants eg Methylphenidate or Non-stimulants eg atomoxetine 6years). The dose and frequency of medicine will be as per doctors discretion  
Intervention  ten-on-ten syrup   Ten-on-ten syrup will be given to ADHD diagnosed children for duration of 6 months. The dosage of the medication will be as followed: 5 ml twice daily for 180 days (for children below 8 years)and 15 ml twice a day for 180 days (for children above 8 years)  
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  1. Children aged between 6-12 years who are diagnosed with mild to moderate ADHD.
2. Children irrespective of gender, religion, socio-economic status.
3. Patient’s parent/legal guardian who is ready to sign Consent Form.
 
 
ExclusionCriteria 
Details  1. Children less than 6 years and more than 12 years.
2. Children with Epilepsy and taking anti-epileptic medications.
3. Children with severe comorbid conditions like oppositional defiant disorder, conduct disorder, substance abuse, anxiety disorder.
4. History of hypersensitivity or food allergy to components of omega 3/6, ( fish like salmon, mackerel, tuna, sardines, shellfish or flaxseed oil, Nuts and seeds such as flaxseed, chia seeds, and walnuts), herbal supplements shall be elicited on medical history.
5. Children taking anticoagulant medications like warfarin or aspirin.
6. Children with chronic systemic disease or other major psychiatric disorders.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Improvement in signs and symptoms of ADHD assessed using Vanderbilt assessment scale-parent version.  24 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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 4 
Date of First Enrollment (India)   15/06/2024 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Attention Deficit Hyperactivity Disorder (ADHD) is a neurodevelopmental disorder characterized by persistent pattern of inattention and/or hyperactivity-impulsivity, interfering with functioning and development. The global prevalence rate of ADHD is around 5–10% . Children with ADHD have significant adverse outcomes such as educational problems, difficult peer relationships and increased rates of motor vehicle accidents, accidental injuries, and substance misuse. Since past two decades, the research on ADHD in western population has been accelerating, yet research on ADHD in India is on the rise only since the last decade. Ten-on-ten syrup is such alternative treatment which is an over-the-counter product, with no alcohol, no sedation, non-habit forming brain wellness tonic which is free from heavy metals. The objective is to evaluate improvement in signs and symptoms of ADHD after using ten-on-ten syrup based on Vanderbilt Assessment Scale-parent version. This study is a prospective, interventional, randomised, two-arm, single centre study. The inclusion criteria for the study is children (of all genders and any religion) aged between 6-12 years who are diagnosed with mild to moderate ADHD. Exclusion criteria for the study includes, children less than 6 years and more than 12 years, children with Epilepsy and taking anti-epileptic medications. children with severe comorbid conditions like oppositional defiant disorder, conduct disorder, substance abuse, anxiety disorder, history of hypersensitivity or food allergy to components of omega 3/6, herbal supplements shall be elicited on medical history, Children taking anticoagulant medications like warfarin or aspirin and children with chronic systemic disease or other major psychiatric disorders. The duration of the study is six months. Study Intervention which is the Ten-on-ten syrup will be given to ADHD diagnosed children for duration of 6 months. Data parameters for the study include demographic details, physical assessment, Vanderbilt Assessment parent version scale and follow up scale-parent version scores. The outcome of the study is to evaluate the improvement in signs and symptoms of ADHD assessed using Vanderbilt assessment scale-parent version.

 
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