| 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
|
|
|
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
|
|
|
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. |