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CTRI Number  CTRI/2024/03/064400 [Registered on: 19/03/2024] Trial Registered Prospectively
Last Modified On: 01/03/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Ayurveda Treatment Protocol in management of Autism in children 
Scientific Title of Study   Evaluation of Ayurveda Treatment Protocol in management of Autism in children – A Randomised 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 Kaveri Hulyalkar 
Designation  Asst Prof  
Affiliation  KAHER shri BMK Ayurveda Hospital , Belagavi 
Address  KAHER Shri BMK Ayurveda Hospital Shahapur Belagavi Department of kaumarbhritya - OPD Num 10 / 11
KAHER Shri BMK Ayurveda Hospital Shahapur Belagavi Department of kaumarbhritya - OPD Num 10 / 11
Belgaum
KARNATAKA
590003
India 
Phone  09538900603  
Fax    
Email  kaverihulyalkar@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Kaveri Hulyalkar 
Designation  Asst Prof  
Affiliation  KAHER shri BMK Ayurveda Hospital , Belagavi 
Address  KAHER Shri BMK Ayurveda Hospital Shahapur Belagavi Department of kaumarbhritya Room num 10 /11
KAHER Shri BMK Ayurveda Hospital Shahapur Belagavi Department of kaumarbhritya Room num 10 /11
Belgaum
KARNATAKA
590003
India 
Phone  09538900603  
Fax    
Email  kaverihulyalkar@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Aziz arbar  
Designation  Prof HOD Dept OF Kaumarabhritya  
Affiliation  kaher shri BMKAM shahapur belagavi 
Address  KAHER Shri BMK Ayurveda Hospital Shahapur Belagavi Department of kaumarbhritya Room num 10 / 11
KAHER Shri BMK Ayurveda Hospital Shahapur Belagavi Department of kaumarbhritya Room num 10 / 11
Belgaum
KARNATAKA
590003
India 
Phone  9844532113  
Fax    
Email  azizarbar@gmail.com  
 
Source of Monetary or Material Support  
KAHER Shri BMK Ayurveda mahavidyalaya , shahapur , belagavi  
 
Primary Sponsor  
Name  KLE Ayurveda Hospital  
Address  KAHER shri BMK Ayurveda mahavidyalaya shahapur , belagavi 
Type of Sponsor  Research institution and hospital 
 
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 Kaveri Hulyalkar   KLE ayurveda hospital shahapur belagavi  KAHER shri BMKAM , department of Kaumarabhritrya Room num 10 /11 sHAHAPUR bELAGAVI
Belgaum
KARNATAKA 
9538900603

kaverihulyalkar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KLE University Shri BMK Ayurved mahavidyalaya & KLE Ayurved Hospital, shahapur, Belagavi   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:F54||Psychological and behavioral factors associated with disorders or diseases classified elsewhere. Ayurveda Condition: UNMADAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-aBya~ggaH, अभ्यंग  (Procedure Reference: charaka chikitsa unmaad chikitsa, Procedure details: Materials required for smooth conduction of abhyanga followed by nadi swedana has to be collected, they include oil, vessel, water, gas stove and pressure cooker, nadi yantra attached over its nozzel cotton. • The child is allowed to stay in comfortable position. • Smear oil and massage the luke warm oil over head, ear, neck, face, upper extrimities, trunk, lower extremities for a duration of 35 to 40 mins with 7 distinct position. • Steam is applied to affected part using nadi yantra)
(1) Medicine Name: ksheerabala taila , Reference: charka chikitsa unmaad , Route: Topical, Dosage Form: Taila, Dose: 40(ml), Frequency: od, Duration: 38 Days
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  16.00 Year(s)
Gender  Both 
Details  Children of either sex between the age group of 3yrs-16 yrs
Children satisfying DSM5 diagnostic criteria for autism will be included for the study
 
 
ExclusionCriteria 
Details  At the time of enrollment, if the child is found to be non-inclusive due to underlying health condition or medication will be excluded
Children with any acute or chronic,local or systemic infection will be excluded.
Children with any Congenital malformations will be excluded
Children who are currently under any other medications will be excluded
At the time of enrollment,if the child is found to be no n inclusive due to underlying health condition or medication will be excluded
Children with any acute or chronic,local or systemic infection will be excluded.
Children with any Congenital malformations will be excluded
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate the effect of ayurveda treatment protocol
and to improve the quality of life  
To evaluate the effect of ayurveda treatment protocol
and to improve the quality of
life
Time points - 7 th day , 38 th day  
 
Secondary Outcome  
Outcome  TimePoints 
There might be effect of ayurveda treatment protocol   0th day - enrollment
7 th day - assesment , follow up
38 th day - assesment , follow up  
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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 1/ Phase 2 
Date of First Enrollment (India)   30/03/2024 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

Autism is a heterogeneous neurodevelopmental condition manifesting in early childhood. [1]The abilities and needs of people with autism vary. While some can live independently , most of the them will have severe disabilities and require lifelong care and support. According to WHO, It is an emerging global concern with 1 in 160 children diagnosed with autism[1] . In India, 01 in every 88 children is diagnosed with Autism[2]. It is approximately four times more common in males than females.

 At present no  medications  are established  to  treat its core  symptoms. Risperidone and Aripiprazole are the only FDA approved medication targeting the irritability seen with this diagnosis. Moreover, Children and adolescents with autism appear to be more susceptible to adverse effects with these medications[3]. The line of treatment commonly used is speech therapy, psychotherapy, occupational therapy, behaviour training and dietary modification. These treatments are time consuming and need of much manpower. Because of all the above reasons, there is a need to find a new approach and modality for Autism.

In Ayurveda, the autism can be understood under the concept of Unmada. In this study, we are planning the Ayurveda  Panchakarma treatment protocol  which includes sarvanaga Abhyanga, Nasya, matrabasti and shrotalam which will be beneficial in autistic children. Hence an effort is made to evaluate the effect of Ayurveda treatment protocol in autism in specified number of samples.

 
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