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CTRI Number  CTRI/2025/02/080701 [Registered on: 17/02/2025] Trial Registered Prospectively
Last Modified On: 03/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Other (Specify) [Parental advise for occupational therapy]  
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   A study on effect of ayurvedic management in children with Sensory processing dysfunction associated with Autism Spectrum Disorders of age group 3-12 years. 
Scientific Title of Study   Non Randomised contolled trial on the add-on effect of Kolakulathadi pradeham in Sensory Processing Dysfunction associated with Autism Spectrum Disorders in children of age group 3-12 years 
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 Arsha Unni 
Designation  PG Scholar 
Affiliation  Govt. Ayurveda College Trivandrum, Kerala- 695001 
Address  Department of Kaumarabhrithya,Government Ayurveda College Thiruvananthapuram, Kerala

Thiruvananthapuram
KERALA
695001
India 
Phone  8848817924  
Fax    
Email  arsha384@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Roshni Anirudhan 
Designation  Professor, HOD and Guide 
Affiliation  Govt. Ayurveda College Trivandrum, Kerala- 695001 
Address  Department of Kaumarabhrithya, Government Ayurveda College Thiruvananthapuram, Kerala

Thiruvananthapuram
KERALA
695001
India 
Phone  9447006585  
Fax    
Email  doctoroshni@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Roshni Anirudha 
Designation  Professor, HOD and Guide 
Affiliation  Govt. Ayurveda College Trivandrum, Kerala- 695001 
Address  Department of Kaumarabhrithya, Government Ayurveda College Thiruvananthapuram, Kerala

Thiruvananthapuram
KERALA
695001
India 
Phone  9447006585  
Fax    
Email  doctoroshni@gmail.com  
 
Source of Monetary or Material Support  
Women and Child Hospital Poojappura, Thiruvananthapuram, Kerala-695012 
 
Primary Sponsor  
Name  Dr Arsha Unni 
Address  Government Ayurveda College Thiruvananthapuram -695001 
Type of Sponsor  Other [Self funding] 
 
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 Roshni Anirudhan  Women and Child Hospital , Poojappura  Department of Kaumarabhrithya, Government Ayurveda College Thiruvananthapuram, Kerala
Thiruvananthapuram
KERALA 		 9447006585

doctoroshni@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
GAVC THIRUVANANTHAPURAM INSTITUTIONAL ETHICAL COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:F840||Autistic disorder. Ayurveda Condition: UNMADAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-pradeha, प्रदेह (Procedure Reference: Susruta samhitha sutradthana 18 th chapter 6 th verse, Procedure details: Mix the medicines to form a paste & apply over skin as lepam with a thickness of about 4-5 mm)
(1) Medicine Name: Kolakulathadi choornam, Reference: Charaka samhitha sutra sthana 3 rd chapter, Route: Topical, Dosage Form: Lepa Churna, Dose: 500(g), Frequency: od, Duration: 28 Days
(2) Medicine Name: Dhanwantaram tailam, Reference: Sahasrayoga taila prakarana, Route: Topical, Dosage Form: Taila, Dose: 250(ml), Frequency: od, Duration: 28 Days
2Comparator ArmDrugClassical(1) Medicine Name: Kalyanaka ghrtam, Reference: Ashtanga hrdaya uttaratantra 6 th chapter 27 th verse, Route: Oral, Dosage Form: Ghrita, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: -hot water), Additional Information: -nil
3Intervention ArmDrugClassical(1) Medicine Name: Kalyanaka ghrtam, Reference: Ashtanga hrdayam uttaratantra 6 th chapter 27 th verse, Route: Oral, Dosage Form: Ghrita, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: -hotwater), Additional Information: -nil
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  1.3-12 year old children satisfying the DSM 5 criteria for Autism Spectrum Disorder
2.Children with a score in the definite or probable difference range in one or more domains of the Sensory Profile 2
 
 
ExclusionCriteria 
Details  1.Other forms of ASD like Aspergers Syndrome, PDD NOS.
2.Children with Neuro Degenerative Disorders.
3.Children with intractable epilepsy.
4.Children with eruptive skin lesions.
5.Children with profound hearing and visual loss clinically

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Change in scores in various domains of Sensory profile 2 including auditory, visual, olfactory,tactile, vestibular or multisensory processing  before and after 28 days of intervention, after follow up period of 14 days 
 
Secondary Outcome  
Outcome  TimePoints 
Changes in the scores in social relation and reciprocation,emotional responsiveness,speech-language and communicaton,beahiour patterns,sensory aspects,cognitive component will be asessed using Indian Scale for Asessment of Autism  before and after 28 days of intervention, after follow up period of 14 days 
 
Target Sample Size   Total Sample Size="32"
Sample Size from India="32" 
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/ Phase 4 
Date of First Enrollment (India)   01/03/2025 
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="1"
Months="6"
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  

Non Randomized Controlled Trial will be carried out after 32 subjects satisfying the inclusion criteria are selected and  control group given Kalyanaka ghrita and parental advise for sensory integration exercises by an occupational therapist.and trial group with Kolakukathadi pradeha along with Kalyanaka ghrita and parental advise for sensory integration exercises by an occupational therapist.Kalyanaka ghrita will be given internally(10-20ml) in divided dose twice daily and Kolakukathadi choorna processed in Bala ksheera along with Dhanwantaram tailam will be used for pradeha externally over the skin.Period of intervention is 28 days and blinded asessment will be done before and after the treatment by an occupational therapist using Sensory Profile 2 and effect of intervention on social relation and reciprocation,emotional responsiveness, speech-language and communicaton,behaviour patterns,sensory aspects,cognitive component will be  assessed using Indian Scale for Asessment of Autism.

 
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