| CTRI Number |
CTRI/2021/07/035308 [Registered on: 30/07/2021] Trial Registered Prospectively |
| Last Modified On: |
05/08/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Clinical Study to compare efficacy of add-on Ayurveda treatment versus Allopathy treatment in Attention deficit hyperactivity disorder. |
|
Scientific Title of Study
|
Evaluating the efficacy of ayurvedic intervention as add on to conventional treatment and explore the interaction of epigenetics, neuro/gut biomarkers and neuroimaging in pediatric ADHD (Attention Deficit Hyperactivity Disorder)
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr K John Vijay Sagar |
| Designation |
Professor and Head, Department of Child and Adolescent Psychiatry. |
| Affiliation |
National Institute of Mental Health and Neurosciences |
| Address |
Department of Child and Adolescent Psychiatry, National Institute of Mental Health and Neurosciences.
Bangalore
KARNATAKA
560029
India |
| Phone |
9686062710 |
| Fax |
|
| Email |
sagarjohn@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K John Vijay Sagar |
| Designation |
Professor and Head, Department of Child and Adolescent Psychiatry. |
| Affiliation |
National Institute of Mental Health and Neurosciences |
| Address |
Department of Child and Adolescent Psychiatry, National Institute of Mental Health and Neurosciences.
Bangalore
KARNATAKA
560029
India |
| Phone |
9686062710 |
| Fax |
|
| Email |
sagarjohn@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kishore Kumar Ramakrishna |
| Designation |
Professor of Ayurveda, Department of Integrative Medicine. |
| Affiliation |
National Institute of Mental Health and Neurosciences |
| Address |
Department of Integrative Medicine, National Institute of Mental Health and Neurosciences.
Bangalore
KARNATAKA
560029
India |
| Phone |
9845829174 |
| Fax |
|
| Email |
ayurkishore@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Council for Research in Ayurvedic Sciences Jawahar Lal Nehru Bhartiya Chikitsa Avum Homeopathy Anusandhan Bhavan
No.61-65, Institutional Area, Opp. D Block, Janakpuri,
New Delhi - 110058 ( India ) |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Ayurvedic Sciences |
| Address |
Ministry of AYUSH, Government of India
61-65, Institutional Area, Opposite “D†Block,
Janakpuri, New Delhi - 110058 |
| Type of Sponsor |
Government funding agency |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr K John Vijay Sagar |
National Institute of Mental Health and Neurosciences |
Department of Child and Adolescent Psychiatry, NIMHANS, Hosur Main Road, Bengaluru 560029
Bangalore
KARNATAKA |
9686062710
sagarjohn@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Human Ethics Committee for Research in AYUSH and Integrative Medicine |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F90||Attention-deficit hyperactivity disorders. Ayurveda Condition: ANAVASTHITACITTATVAMÂ (KEVALAVATA), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Add-on Ayurveda intervention to Conventional treatment |
1) Tablet Ayushmana - 2 tablets twice a day.
2) Bramha Rasayana - 5 grams
twice a day.
3) Jyotishmati Taila - 5 drops twice a day.
Route of administration - Oral. |
| Comparator Agent |
Conventional treatment |
1) Tablet Clonidine - 3 to 7 micrograms/Kg per day in two or three divided doses.
2) Tablet Methylphenidate IR - 0.3 to 0.5 mg/Kg/dose per day in two or three divided doses.
3) Tablet Methylphenidate SRC- 0.5 to 2 mg/Kg/day as a single dose in the morning.
4) Tablet Atomoxetine - 0.5mg/Kg/day to a maximum of 1.2 mg/Kg/day.
Route of administration - Oral. |
|
Inclusion Criteria
Modification(s)
|
| Age From |
6.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
• Children and adolescents of both sex in age group of 6-15 years
• Fulfilling DSM -5 criteria for the diagnosis of ADHD
• Patients receiving treatment as per Standard of care.
• Patients or parent/caregiver without any psychotic disease or any mental situation which may cause the concern to properly complete the questionnaires.
• Patients whose can understand and fill up required forms.
|
|
| ExclusionCriteria |
| Details |
1. Known or suspected severe mental retardation or significant learning disorder & Children with co-existing moderate – severe Neuro-psychological conditions or autism spectrum disorder.
2. Subjects who require drug therapy or hospitalization for treatment of a chronic psychiatric illness.
3. Patient with inability to swallow the medication whole, and those with any unstable medical illness.
4. Parents who do not give consent for the study.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) Change in Conners Parent Rating Scale - Revised.
2) Change in Conners Teachers Rating Scale - Revised. |
6 Months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in modified AIIMS-INCLEN Diagnostic tool for ADHD. |
6 months |
| Change in T scores of Child Behaviour Check List (CBCL) |
6 months |
| Change in Gut Microbiota |
6 months |
| Change in methylation pattern in epigenome |
6 months |
Change in neuropsychological functions
1) assessed on children (arousal of attention;
reaction time; sustained attention; delay aversion;
planning; and executive functions such as,
working memory, cognitive inhibition, set/task
shifting)
2) changes in parent’s report on the executive
functions of their children |
6 months |
Changes in biomarkers of neurological
implications BDNF, beta endorphins and Telomere
shortening |
6 months |
Changes in modulation of the functional brain
network connectivity (during resting-state and stop-signal
response inhibition task) |
6 months |
Safety of Ayurveda interventions assessed clinically and
in biochemical parameters |
6 months |
Changes in inter-relationships
among the gut and neurological biomarkers |
6 months |
|
|
Target Sample Size
|
Total Sample Size="160"
Sample Size from India="160"
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)
|
03/08/2021 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a randomized single-blind, parallel-group trial comparing the safety and efficacy of Add-on Ayurveda intervention (Ayushmana, Bramha Rasayana, and Jyotishmati Taila) and Conventional treatment (Clonidine, Methylphenidate, and Atomoxetine) daily for six months in 160 subjects (80 in each group) with Attention Deficit Hyperactivity Disorder (ADHD) that will be conducted at National Institute of Mental health and Neurosciences (NIMHANS) Bengaluru. The primary outcome measure will be Changes in Conners’ Parent Rating Scale-Revised (CPRS-R) and Conners’ Teacher Rating Scale-Revised (CTRS-R) at six months. The secondary outcome measures are Changes in the modified AIIMS- INDT ADHD tool, Changes in T scores of Child behavior
Checklist, Changes in the Gut microbiota, Changes in biomarkers of
neurological implications, modification in the inter-relationships among the gut and neurological biomarkers, Changes in methylation pattern in epigenome, Changes in neuropsychological functions (Assessed on children - Arousal of attention; reaction time; sustained attention; delay aversion;
planning; and executive functions such as working memory, cognitive
inhibition, set/task shifting, and changes
in parent’s report on the executive functions of their children), Modulation of the functional brain network connectivity and Safety of Ayurveda interventions at six months. |