| CTRI Number |
CTRI/2019/07/020102 [Registered on: 09/07/2019] Trial Registered Prospectively |
| Last Modified On: |
10/11/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of supplementations in children with Autism Spectrum Disorders |
Scientific Title of Study
Modification(s)
|
Practice, perception of complementary and alternative medicine use among parents of autism spectrum disorder (ASD) children and effect of L-carnosine and pyridoxine-magnesium sulphate in children with ASD |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Debi Ann Abraham |
| Designation |
Research Scholar |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
G-Block 5th floor,
Department of Pharmacy Practice,
Faculty of Pharmacy
Sri Ramachandra Institute of Higher Education and Research
Porur, Chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
|
| Fax |
|
| Email |
debiann94@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr N Udayakumar |
| Designation |
Associate Professor |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Department of Paediatric Medicine
Sri Ramachandra Institute of Higher Education and Research
Porur, Chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
|
| Fax |
|
| Email |
drnuday@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr M G Rajanandh |
| Designation |
Assistant Professor |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Department of Pharmacy Practice
Faculty of Pharmacy
Sri Ramachandra Institute of Higher Education and Research
Porur, Chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
|
| Fax |
|
| Email |
rajanandh.mg@sriramachandra.edu.in |
|
|
Source of Monetary or Material Support
|
| Sri Ramachandra Founder-Chancellor Shri N.P.V.Ramasamy Udayar Research Fellowship |
|
|
Primary Sponsor
|
| Name |
Brio Bliss Life Science Pvt Ltd |
| Address |
New No 31, Old No 14,
Thiruvengadam Street
Mandaveli, Chennai-600028 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Debi Ann Abraham |
Karthikeyan Child Development Unit |
2nd floor C-2 room,
Department of Paediatric Medicine,
Sri Ramachandra Medical Centre,
Sri Ramachandra Institute of Higher Education and Research
Porur, Chennai-600116
Chennai
TAMIL NADU |
9003179965
debiann94@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, SRIHER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F988||Other specified behavioral and emotional disorders with onset usually occurring in childhood and adolescence, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
L-Carnosine |
L-Carnosine(10-15mg/kg) along with standard care(occupational and speech therapy) |
| Intervention |
Pyridoxine-Magnesium sulphate |
20mg Pyridoxine hydrochloride and 40mg Magnesium sulphate for 3 year old,
Pyridoxine hydrochloride 30mg and 60mg Magnesium sulphate for 4-6 year old child along with standard care(occupational and speech therapy) |
| Comparator Agent |
standard care |
standard care(occupational and speech therapy) |
|
Inclusion Criteria
Modification(s)
|
| Age From |
3.00 Year(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
children between the ages of 3 and 6 years who were having mild to moderate ASD diagnosed using Childhood Autism Rating Scale, Second Edition-Standard Version(CARS2-ST) and INCLEN Diagnostic tool for Autism Spectrum Disorder. |
|
| ExclusionCriteria |
| Details |
children undergoing any chronic drug treatment, severe intellectual disability, history of seizure, presence of hepatic disease, having any other genetic and chromosomal syndromes as well as children with chronic illness or known hormonal and metabolic diseases. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| To assess the effect of L-carnosine and pyridoxine-magnesium sulphate in children with ASD |
0,2 months |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| practice, perception of complementary and alternative medicine use among parents of ASD children |
0 |
|
Target Sample Size
Modification(s)
|
Total Sample Size="96"
Sample Size from India="96"
Final Enrollment numbers achieved (Total)= "96"
Final Enrollment numbers achieved (India)="96" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/10/2019 |
| Date of Study Completion (India) |
17/05/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
1. Debi Ann, A., Udayakumar, N., Senta, C., & Rajanandh, M. G. (2020). Pyridoxine and Magnesium Administration-Induced Hyperactivity in Two Children With Autism Spectrum Disorder: Case Reports From a Clinical Trial. Clinical therapeutics, 42(11), e250–e258.
2.• Ann Abraham, D., Narasimhan, U., Christy, S. et al. Effect of L-Carnosine as adjunctive therapy in the management of children with autism spectrum disorder: a randomized controlled study. Amino Acids 52, 1521–1528 (2020). |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This study assessed the practice and perception of complementary and alternative medicine use among parents of children with ASD. To parents who were willing, ASD children were given L-carnosine and pyridoxine-magnesium along with occupational and speech therapy and assessed for autism severity, sleep problems, gastrointestinal problems and parental stress. ADR reported in the pyridoxine-magnesium group lead to discontinuation of this group and study was continued with L-carnosine and standard care arms. As L-carnosine was found to be not effective in children with ASD, plasma concentration of L-carnosine was determined and correlated with clinical outcome. Even though sufficient plasma concentrations of L-carnosine were obtained, there was no significant change in autism symptoms. |