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CTRI Number  CTRI/2023/01/049123 [Registered on: 20/01/2023] Trial Registered Prospectively
Last Modified On: 10/01/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to compare the efficacy of Ashtanga Ghrita and Panchabhoutika Ghrita Pratimarsha Nasya on Speech in Autistic Children 
Scientific Title of Study   Randomized Comparative Clinical Study to evaluate the effect of Ashtanga Ghrita and Panchabhoutika Ghrita Pratimarsha Nasya on Speech in Autistic Children 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Prakruthi R 
Designation  PG Scholar 
Affiliation  Sri Sri College of Ayurvedic Science and Research Hospital Banglore 
Address  OPD NO 9 Dept of PG Studies in Kaumarabhritya Sri Sri College of Ayurvedic Science and Research Hospital 21st km Kanakpura Rd Udayapura PO OB Chudahalli Banglore

Bangalore
KARNATAKA
560082
India 
Phone  9741799296  
Fax    
Email  prakruthi139@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Deshpande Sharvari Sunil 
Designation  Associate Professor 
Affiliation  Sri Sri College of Ayurvedic Science and Research Hospital Banglore 
Address  OPD NO 9 Dept of PG Studies in Kaumarabhritya Sri Sri College of Ayurvedic Science and Research Hospital 21st km Kanakpura Rd Udayapura PO OB Chudahalli Banglore

Bangalore
KARNATAKA
560082
India 
Phone  9901059707  
Fax    
Email  drsharvarideshpande@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Deshpande Sharvari Sunil 
Designation  Associate Professor 
Affiliation  Sri Sri College of Ayurvedic Science and Research Hospital Banglore 
Address  OPD NO 9 Dept of PG Studies in Kaumarabhritya Sri Sri College of Ayurvedic Science and Research Hospital 21st km Kanakpura Rd Udayapura PO OB Chudahalli Banglore


KARNATAKA
560082
India 
Phone  9901059707  
Fax    
Email  drsharvarideshpande@gmail.com  
 
Source of Monetary or Material Support  
Sri Sri College of Ayurvedic Science & Research Hospital, Bengaluru 
 
Primary Sponsor  
Name  Dr. Prakruthi R 
Address  OPD NO 9 Dept of PG Studies in Kaumarabhritya Sri Sri College of Ayurvedic Science and Research Hospital 21st km Kanakpura Rd Udayapura PO OB Chudahalli Banglore 560082 
Type of Sponsor  Other [SELF] 
 
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 Prakruthi R  Sri Sri College of Ayurvedic Science and Research Hospital Banglore   OPD NO 9 Dept of PG Studies in Kaumarabhritya Sri Sri College of Ayurvedic Science and Research Hospital 21st km Kanakpura Rd Udayapura PO OB Chudahalli Banglore 560082
Bangalore
KARNATAKA 
9741799296

prakruthi139@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SRI SRI INSTITUTIONAL 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: JADATVA (Autism),  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-pratimarSaH, प्रतिमर्श (Procedure Reference: sushruta samhitha, chikitsa sthana, 40th chap, verse 51-53 , Procedure details: 2 drops of ashtanga ghrita instilled in each nostril in the morning after bath for 30 days )
(1) Medicine Name: ashtanga ghrita, Reference: ashtanga hrudaya uttara sthana 1st chap, Route: Nasal, Dosage Form: Ghrita, Dose: 2(drops), Frequency: od, Duration: 30 Days
2Comparator ArmProcedure-pratimarSaH, प्रतिमर्श (Procedure Reference: sushruta samhita chikitsa sthana 40th chap. verse 51-53 , Procedure details: 2 drops of panchabhoutika ghrita instilled in each nostril in the morning after bath for 30 days.)
(1) Medicine Name: panchabhoutika ghrita , Reference: kashyapa samhitha, kalpa sthana 4th chapter , Route: Nasal, Dosage Form: Ghrita, Dose: 2(drops), Frequency: od, Duration: 30 Days
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  10.00 Year(s)
Gender  Both 
Details  1.Children between 5-10 years of age diagnosed with autism as per DSM-5 criteria irrespective of gender, religion and socio-economic status. 

2.Autistic children with speech defects will be included. 
 
ExclusionCriteria 
Details  1.Children below 5 years and above 10 years of age.

2.Children diagnosed with other Autism Spectrum disorders like Asperger’s disorder, Rett syndrome, Pervasive Developmental Disorder (PDD), Childhood Disintegrative Disorder, Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS) etc.

3.Children with other systemic illness will be excluded. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
40 components among 6 domains of ISAA(Indian Scale for assessment of Autism) will be assesed  0th day
45th day
60th day 
 
Secondary Outcome  
Outcome  TimePoints 
Reduction in ISAA score will be assessed  45th day
60th day 
 
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 2 
Date of First Enrollment (India)   25/01/2023 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
Childhood is the period of physical, cognitive and social development that begins at birth and continues through early adulthood. Autism is one of the neurodevelopmental disorder characterized by difficulties with social interaction and communication; restricted and repetitive behaviour. About 1 in 100 children in India under the age of 10 have autism, and nearly 1 in 8 has at least one neurodevelopmental condition. Speech, language and communication skills are crucial to overall development of children. Being able to speak clearly, process speech sounds, to understand others, to express ideas and  to interact with others are fundamental building blocks for a child’s development.Children with Autism have difficulty in developing language skills, both in terms of comprehension and communication. They often have difficulty in communicating verbally and non-verbally. Speech impairment in autistic child, may lead to impairment in his/her socialization, education and behavior. Speech impairment affects social life negatively by affecting familial relationship and also interaction with children of their own age. It also has a negative impact on education leading to lowered academic expectations, limitations on teacher-child relationship. Because of behavioral changes of autistic children, parents find it difficult to take them to the social gatherings and send them to the normal school. Speech therapy may seems to promise more than it can deliver. Although this is by far the most desirable choice, some children may not easily acquire intelligible vocal speech. Autism is considered as the state of Jadatva (inertia) with Tamo avarana (covering with darkness) of Buddhi (intelligence), Manas (mind) and Vagindriya (sense organ of speech). Ayurveda mentions certain Yogas(formulations), which promote intelligible vocal speech by stimulating Vagindriya in Shiras. Among them Ashtanga ghritha  and Panchabhoutika ghrita , are few formulations which are said to enhance Vak, Medha, Smrithi etc.  As Nasa (nasal cavity) is the nearest route for Shiras, the drugs administered through Nasya will have a quicker effect on Vagindriya and helps in improving the 2 components of Vak. This study is an effort to evaluate the effect of Ashtanga ghrita and Panchabhoutika ghrita Pratimarsha Nasya on speech in autistic children.


 
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