| CTRI Number |
CTRI/2021/12/038875 [Registered on: 23/12/2021] Trial Registered Prospectively |
| Last Modified On: |
18/11/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
TO UNDERSTAND THE EFFECTIVENESS OF HINGUVADI GHRITAPANA AND JATAMAMSADI TAILA NASYA IN THE TREATMENT OF AUTISM IN CHILDREN |
|
Scientific Title of Study
|
EFFICACY OF HINGUVADI GHRITAPANA AND JATAMAMSADI TAILA NASYA IN THE MANAGEMENT OF AUTISM IN CHILDREN- AN OPEN LABELLED CLINICAL TRIAL |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vaishnavi V |
| Designation |
PG Scholar |
| Affiliation |
KAHER Shri BMK Ayurveda Mahavidyalaya |
| Address |
Department of Kaumarabhritya
Shri BMK Ayurveda Mahavidyalaya
Shahapur
Belagavi
Belgaum
KARNATAKA
590003
India |
| Phone |
9790355971 |
| Fax |
|
| Email |
vaishnaviv.vijayan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr AZIZ AHMED I ARBAR |
| Designation |
PROFESSOR AND HOD, DEPARTMENT OF KAUMARABHRITYA |
| Affiliation |
KAHER Shri BMK Ayurveda Mahavidyalaya |
| Address |
Shri BMK Ayurveda Mahavidyalaya
Shahapur
Belagavi
Belgaum
KARNATAKA
590003
India |
| Phone |
9844532113 |
| Fax |
|
| Email |
azizarbar.kaher@kleayurworld.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vaishnavi V |
| Designation |
PG Scholar |
| Affiliation |
KAHER Shri BMK Ayurveda Mahavidyalaya |
| Address |
Department of Kaumarabhritya,
Shri BMK Ayurveda Mahavidyalaya
Shahapur
Belagavi
Belgaum
KARNATAKA
590003
India |
| Phone |
9790355971 |
| Fax |
|
| Email |
vaishnaviv.vijayan@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLE Ayurveda Hospital, Shahapur, Belagavi, Karnataka - 590003 |
|
|
Primary Sponsor
|
| Name |
Shri BMK Ayurveda Mahavidyalaya |
| Address |
Shri BMK Ayurveda Mahavidyalaya
Shahapur
Belagavi - 590003
|
| 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 Vaishnavi V |
KLE Ayurveda Hospital |
OPD no 11, Department of Kaumarabhritya , Kle ayurveda Hospital,Shahapur
Belagavi
Belgaum
KARNATAKA |
9790355971
vaishnaviv.vijayan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Research and Human Subject |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F840||Autistic disorder. Ayurveda Condition: Autism , |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: HINGUADI GHRITA, Reference: SUDHRUTA SAMHITA , Route: Oral, Dosage Form: Ghrita, Dose: 5(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: WARM WATER ), Additional Information: | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: JATAMAMSADI TAILA, Reference: SUSHRUTA SAMHITA, Route: Nasal, Dosage Form: Bindu/ Drops (Karna/ Nasa/ Netra), Dose: 2(drops), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
Children satisfying diagnostic criteria |
|
| 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
Children who are currently under any other medication will be excluded |
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| There will be significant effect of Hinguvadi Ghritapana and Jatamamsadi Taila Nasya in the management of autism |
7TH,22ND AND 45TH DAYS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| There will be significant effect of Hinguvadi Ghritapana and Jatamamsadi Taila Nasya in the management of autism |
7TH,22ND AND 45TH DAYS |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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
|
N/A |
|
Date of First Enrollment (India)
|
03/02/2022 |
| 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
|
NIL |
|
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 childhoo The abilities and needs of people with autism
vary. While some can live independently , most of 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. In India ,1 in every 88 children is diagnosed with Autism. 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 medications currently used, targeting
the irritability seen with this diagnosis. Moreover, Children and adolescents
with autism appear to be more susceptible to adverse effects with these
medications.The line of treatment, commonly used are speech
therapy, psychotherapy, occupational therapy, behaviour training and dietary
modification. These treatments are time
and staff intensive.Because
of all the above reasons, there is a need to find a new approach and modality
for Autism . In Autism ,the
brain and components of the brain are affected . Available evidence
suggests that around 21-70% of children
with autism have gastrointestinal symptoms. This attributes to the
concept of gut brain axis. In Ayurveda, the exact correlation is not yet clearly identified. Autism can be understood under the concept of Unmada.A defective digestive and metabolic
function is postulated as the root cause of Unmada
In this study, the drugs are taken
from the Aparajitha yoga mentioned for
Sarva manoroga, by Acharya Sushrutha [8].By virtue of the mode of action of Nasya , we can expect a
positive effect on the brain. With this hypothesis, we are administering the Jatamamsadi Taila Nasya in this study.In
this study we are administering Hinguvadi ghrita orally to address the gastrointestinal symptoms
|