| 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 |
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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 |
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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 |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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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 |
|
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Source of Monetary or Material Support
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| Sri Sri College of Ayurvedic Science & Research Hospital, Bengaluru |
|
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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] |
|
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Details of Secondary Sponsor
|
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Countries of Recruitment
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India |
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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 |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRI SRI INSTITUTIONAL COMMITTEE |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F840||Autistic disorder. Ayurveda Condition: JADATVA (Autism), |
|
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | pratimarSaH, पà¥à¤°à¤¤à¤¿à¤®à¤°à¥à¤¶ | (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 | | 2 | Comparator Arm | Procedure | - | pratimarSaH, पà¥à¤°à¤¤à¤¿à¤®à¤°à¥à¤¶ | (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 |
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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.Â
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. |
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Method of Generating Random Sequence
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Coin toss, Lottery, toss of dice, shuffling cards etc |
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Method of Concealment
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Not Applicable |
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Blinding/Masking
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Open Label |
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Primary Outcome
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| Outcome |
TimePoints |
| 40 components among 6 domains of ISAA(Indian Scale for assessment of Autism) will be assesed |
0th day
45th day
60th day |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in ISAA score will be assessed |
45th day
60th day |
|
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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" |
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Phase of Trial
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Phase 2 |
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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 |
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Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
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Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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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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