| CTRI Number |
CTRI/2025/04/085035 [Registered on: 17/04/2025] Trial Registered Prospectively |
| Last Modified On: |
16/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Management of Autism Spectrum Disorder in children through Ayurveda as an add-on to conventional therapy |
|
Scientific Title of Study
|
Management of Autism Spectrum Disorder in children through a comprehensive Ayurveda approach as an add-on to conventional therapy– A randomized control clinical trial |
| 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 Vidyashree Anchan |
| Designation |
Research Officer (Pathology) |
| Affiliation |
Central Ayurveda Research Institute, Bengaluru |
| Address |
Central Ayurveda Research Institute,Thalaghattapura Post, Kanakapura Main Road, Bengaluru 560109
Bangalore
KARNATAKA
560109
India |
| Phone |
8971859797 |
| Fax |
|
| Email |
dr.anchan88@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vidyashree Anchan |
| Designation |
Research Officer (Pathology) |
| Affiliation |
Central Ayurveda Research Institute, Bengaluru |
| Address |
Central Ayurveda Research Institute,Thalaghattapura Post, Kanakapura Main Road, Bengaluru 560109
Bangalore
KARNATAKA
560109
India |
| Phone |
8971859797 |
| Fax |
|
| Email |
dr.anchan88@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vidyashree Anchan |
| Designation |
Research Officer (Pathology) |
| Affiliation |
Central Ayurveda Research Institute, Bengaluru |
| Address |
Central Ayurveda Research Institute,Thalaghattapura Post, Kanakapura Main Road, Bengaluru 560109
KARNATAKA
560109
India |
| Phone |
8971859797 |
| Fax |
|
| Email |
dr.anchan88@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Council for Research in Ayurvedic Sciences, New Delhi, India. Pin code-110058 |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Ayurvedic Sciences, New Delhi |
| Address |
61-65 opp. D Block, Institutional Area, Janakpuri, New Delhi 110058 |
| Type of Sponsor |
Research institution |
|
|
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 Vidyashree Anchan |
CARI Bengaluru |
#12, Uttarahalli Manavarthe kaval, Uttarahalli, Hobli, Kanakpura Main Road, Valley School Road, Talaghattapura post, Bengaluru, Karnataka - 560109
Bangalore
KARNATAKA |
8971859797
dr.anchan88@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Central Ayurveda Research Institute BengaluruInstitutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F840||Autistic disorder. Ayurveda Condition: UNMADAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Saraswatha Ghritha, Reference: API Part II, Route: Oral, Dosage Form: Ghrita, Dose: 6(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 180 Days, anupAna/sahapAna: Yes(details: Warm water), Additional Information: Ayush Manas 250 mg vati Oral, BD after food with warm water for 180 days Along with Conventional Therapy | | 2 | Comparator Arm (Non Ayurveda) | | - | Conventional Therapy | Occupational therapy, speech therapy, and Individualized Education Plan (IEP). |
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
Participants of any gender in the age group greater than or equal 6 years to less than or equal to 15 years with a confirmed clinical DSM-5 diagnosis of autism spectrum disorder using the DSM-5 criteria.
ISAA score in the range of 70 to 153 including mild viz. 70 to 106 and moderate viz 107 to 153 range of ASD.
Participants whose parents are willing to provide informed written consent.
Participants who are currently not on any medication. If on medication, they may be included after a washout period of 1 month. Concomitant medications may be allowed if the medicine is used for any acute illness which the investigator feels will not jeopardize the trial.
Participants undergoing therapy at a therapy center.
|
|
| ExclusionCriteria |
| Details |
Children with a history or diagnosis of any physical impairment or with any diagnosis of organic brain disorder or any other systemic disorder.
Significant sensory (e.g., blindness, deafness, uncorrected hearing impairment) or motor (e.g., cerebral palsy) impairment.
History of cardiovascular, pulmonary, endocrine diseases or other concurrent severe diseases.
History of any other neurological disorder (Congenital anomalies of the brain and spinal cord, tumors of the brain and spinal cord, Hydrocephalus, Epilepsy, etc.)
History of psychotic disorders of any type, bipolar disorder, schizophrenia and other psychiatric disorders such as anxiety disorders, major depressive disorder, etc.
Participants on any medications psychotropic, anti-epileptic, stabilizers, benzodiazepines, etc.)
Participants who have completed participation in any other clinical trial during the past 2 months.
Any other condition that the investigator thinks may jeopardize the study.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Efficacy of comprehensive Ayurvedic
treatment approach as an add-on to
conventional therapy assessed through the
changes in the score of the Autism
Treatment Evaluation Checklist. |
180 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Efficacy of comprehensive ayurvedic
treatment approach as an add-on to
conventional therapy assessed through the
changes in the scores of ISAA.
Efficacy of comprehensive ayurvedic
treatment approach as an add-on to
conventional therapy assessed through the
changes in the intellectual ability of the
child using Wechsler Intelligence Scales for
Children (WISC)
Efficacy of comprehensive ayurvedic
treatment approach as an add-on to
conventional therapy in the daily living
adaptive functioning assessed through Daily
living skill subscale of the Vineland
Adaptive Behaviour scales.
Efficacy of comprehensive ayurvedic
treatment approach as an add-on to
conventional therapy assessed through the
changes in the quality of life of parents using
the quality of life in Autism Questionnaire
(QoLA) |
180 days |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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 3 |
|
Date of First Enrollment (India)
|
01/05/2025 |
| 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="2"
Months="0"
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 - NO
|
|
Brief Summary
|
This randomized controlled clinical trial aims to evaluate the efficacy of a comprehensive Ayurveda approach as an add-on to conventional therapy in managing Autism Spectrum Disorder (ASD) in children aged 6–15 years. A total of 80 children diagnosed with mild to moderate ASD (ISAA scores 70–153) will be recruited from therapy centres in Bengaluru and randomly assigned to two groups: one receiving only conventional therapy, and the other receiving conventional therapy alongside Ayurveda treatment. The conventional therapy comprises a 10-month integrated program including occupational therapy, speech therapy, and individualized education plans. The Ayurveda intervention includes the administration of Saraswata Ghrita (6g/day before food) and Ayush Manas tablets (2 tablets twice daily after food) for six months. The primary outcome measure is the Autism Treatment Evaluation Checklist (ATEC) score, with secondary objectives focusing on intellectual ability, adaptive daily living functioning, and parental quality of life. Screening and assessment tools include DSM-5, IASQ, ISAA, WISC, Vineland scales, and QoLA, along with laboratory investigations such as CBC, LFT, RFT, Hs-CRP, IL-6, and TNF-alpha. The trial follows a prospective, open-label design with participants assessed across seven visits over a 6-month treatment period. Ethical clearance is obtained. Informed consent from parents and CTRI registration will be ensured before initiation. Data confidentiality and adverse event monitoring will be maintained throughout the study. The findings aim to provide evidence on the potential benefits of integrating Ayurveda with standard care in improving outcomes for children with ASD. |