| CTRI Number |
CTRI/2021/01/030203 [Registered on: 04/01/2021] Trial Registered Prospectively |
| Last Modified On: |
24/12/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To check effect of kusmanda ghrita orally and nasya in behaviour and mental distribution in children |
|
Scientific Title of Study
|
To Evaluate the role of Kushmanda ghrita Internally and pratimarsh nasya im the manegement of Autism spectrum disorder in 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 Priya Kumari |
| Designation |
PG Scholar |
| Affiliation |
Parul Institute of Ayurveda |
| Address |
OPD-103 parul Ayurveda hospital kaumarbhritya department Parul Institute of Ayurveda Parul University post limda vadodara gujarat
OPD-103 parul Ayurveda hospital kaumarbhritya department Parul Institute of Ayurveda Parul University post limda vadodara gujarat
Vadodara
GUJARAT
391760
India |
| Phone |
9536264699 |
| Fax |
|
| Email |
priyakumari199216@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aboli Patil |
| Designation |
Associate Professor |
| Affiliation |
Parul Institute of Ayurveda |
| Address |
OPD-103 parul Ayurveda hospital kaumarbhritya department Parul Institute of Ayurveda Parul University post limda vadodara gujarat
OPD-103 parul Ayurveda hospital kaumarbhritya department Parul Institute of Ayurveda Parul University post limda vadodara gujarat
Vadodara
GUJARAT
391760
India |
| Phone |
9422783313 |
| Fax |
|
| Email |
drabolipatil@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aboli Patil |
| Designation |
Associate Professor |
| Affiliation |
Parul Institute of Ayurveda |
| Address |
OPD-103 parul Ayurveda hospital kaumarbhritya department Parul Institute of Ayurveda Parul University post limda vadodara gujarat
OPD-103 parul Ayurveda hospital kaumarbhritya department Parul Institute of Ayurveda Parul University post limda vadodara gujarat
Vadodara
GUJARAT
391760
India |
| Phone |
9422783313 |
| Fax |
|
| Email |
drabolipatil@gmail.com |
|
|
Source of Monetary or Material Support
|
| Parul University,limda vadodara gujarat. |
|
|
Primary Sponsor
|
| Name |
Department of Kaumarbhritya |
| Address |
Parul Institute of Ayurved Parul University post limda vadodara gujarat |
| Type of Sponsor |
Private medical college |
|
|
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 Priya Kumari |
Parul Ayurved Hospital |
OPD-103 Parul Ayurveda hospital, kaumarbhritya department, Parul Institute of Ayurveda Parul University post limda, vadodara, gujarat
Vadodara
GUJARAT |
9536264699
priyakumari199216@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Human Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F988||Other specified behavioral and emotional disorders with onset usually occurring in childhood and adolescence. Ayurveda Condition: UNMADAH, (2) ICD-10 Condition:F989||Unspecified behavioral and emotional disorders with onset usually occurring in childhood and adolescence. Ayurveda Condition: APASMARAH, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
kushmanda ghrita pratimarsh nasya and oral use |
kushmanda ghrita include kushmanda (benicasa hispida) , yashtimadhu ( GLYCYRRHIZA GLABRA). 2 drop in each nostril in morning dailye with warw water for 60 days and orally For 5 to 10 age 5 ml for 60 days
and orally for 11 to 16 age 7.5 ml for 60 days.
|
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
Pre diagnosed ASD Children belonging to the age group of5 to 16 years, irrespective of gender, religion and socioeconomic status.
Parents/ Guardian willing to give informed written consent to participate in the study. |
|
| ExclusionCriteria |
| Details |
Children below 5 years and above 16 years.
Presence of organic neurological disorders.
Hearing and visual impairment, multiple disabilities.
Patients with known case of acute and chronic systemic illness such as renal diseases, Hepatic dysfunction, Juvenile diabetes mellitus, malignancy.
Progressive and non-progressive neuromuscular disorders, Known neurodegenerative disorder, Cerebral palsy.
Children taking anti-epileptic and anti-psychotic drugs. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Evaluate the role of Kushmandaghrita internally and as Pratimarsha Nasya in ASD children |
60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study the Autism Spectrum disorder as per Ayurveda classics and modern view.
to Improve the quality of life of Autistic children |
60 days |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
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)
|
10/01/2021 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Autism Spectrum disorder (ASD) is a Neurodevelopmental disorder characterized by impaired social interaction, communication, behavioural phenotype that include qualitative impairment in the areas of language, development, presence of stereotyped behaviour, interest and activities. Childhood period is considered as the foundation of the better future life and every incidence has influence on the future life. Children suffered from ASD manifest some degrees of impairment in the areas of reciprocal social interaction, communication, restrictive and repetitive behaviour. In 2013, the American Psychiatric Association merged four distinct autism diagnoses into one umbrella diagnosis of autism spectrum disorder (ASD). They included autistic disorder, childhood disintegrative disorder, pervasive developmental disorder-not otherwise specified (PDD-NOS) and Asperger syndrome. Intervention and Supports- Early intervention can improve learning, communication and social skills, as well as underlying brain development. Applied behaviour analysis (ABA) and therapies based on its principles are the most researched and commonly used behavioural interventions for autism. Many children affected by autism also benefit from other interventions such as speech and occupational therapy. Developmental regression, or loss of skills, such as language and social interests, affects around 1 in 5 children who will be going to be diagnosed with autism and typically occurs between ages 1 and 3. |