| CTRI Number |
CTRI/2024/06/069036 [Registered on: 18/06/2024] Trial Registered Prospectively |
| Last Modified On: |
16/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Management Of Autism In Children |
|
Scientific Title of Study
|
Clinical Study To Evaluate The Combined Effect Of Oral Administration Of Medhya Vati Along With Abhyanga,Shirodhara And Shirothalam In The Management Of Autism In Children |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kavya S |
| Designation |
PG Scholar |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College Of Ayurveda And Hospital |
| Address |
Department of Kaumarabhritya, Sri Dharmasthala Manjunatheshwara College Of Ayurveda And Hospital, Tanniruhalla,Bangalore-Mangalore Highway,Hassan
Hassan
KARNATAKA
573201
India |
| Phone |
9663219549 |
| Fax |
|
| Email |
kavya7058@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shailaja U |
| Designation |
Professor And HOD |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College Of Ayurveda And Hospital, Hassan |
| Address |
Department Of Kaumarabhritya,
Sri Dharmasthala Manjunatheshwara College Of Ayurveda And Hospital, Tanniruhalla,Bangalore-Mangalore Highway,Hassan
Hassan
KARNATAKA
573201
India |
| Phone |
9448816433 |
| Fax |
|
| Email |
Drshailajau@sdmcahhassan.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shailaja U |
| Designation |
Professor And HOD |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College Of Ayurveda And Hospital, Hassan |
| Address |
Department Of Kaumarabhritya,
Sri Dharmasthala Manjunatheshwara College Of Ayurveda And Hospital, Tanniruhalla,Bangalore-Mangalore Highway,Hassan
Hassan
KARNATAKA
573201
India |
| Phone |
9448816433 |
| Fax |
|
| Email |
Drshailajau@sdmcahhassan.org |
|
|
Source of Monetary or Material Support
|
| Sri Dharmasthala Manjunatheshwara College Of Ayurveda And Hospital, Tanniruhalla,Bangalore-Mangalore Highway,Hassan-573201,Karnataka,India |
|
|
Primary Sponsor
|
| Name |
Sri Dharmasthala Manjunatheshwara College Of Ayurveda And HospitalHassan |
| Address |
Sri Dharmasthala Manjunatheshwara College Of Ayurveda And Hospital, Tanniruhalla,Bangalore-Mangalore Highway,Hassan-573201,Karnataka,India |
| 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 Kavya S |
Sri Dharmasthala Manjunatheshwara College Of Ayurveda And Hospital,Hassan |
Department of Kaumarabhritya,
Sri Dharmasthala Manjunatheshwara College Of Ayurveda And Hospital, Tanniruhalla,Bangalore-Mangalore Highway,Hassan-573201,Karnataka,India
Hassan
KARNATAKA |
9663219549
kavya7058@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe Sri Dharmasthala Manjunatheshwara College Of Ayurveda And Hospital,Hassan |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F840||Autistic disorder. Ayurveda Condition: UNMADAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: MEDHYA VATI, Reference: CHARAK SAMHITA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 40 Days, anupAna/sahapAna: Yes(details: -HONEY), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
(a)Children between the age group of 3 to 8 years diagnosed with Autism as per DSM-5 criteria are included irrespective of gender, religion and socio-economic status.
(b)The children whose parents are willing to participate their children in the study and ready to sign the consent form.
(c)Child with Mild to moderate Autism according to ISAA scale will be included.
|
|
| ExclusionCriteria |
| Details |
(a). Children associated with co-morbidity like obsessive-compulsive disorder, seizures, epilepsy will be excluded.
(b). Children associated with any other systemic illnesses will be excluded.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Assessment will be based on improvements in symptoms like
Aggressive Behaviour
Repetitive Behaviour |
Assessment Will be done on 1st, 10th, and 40th day
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the quality of life |
40 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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
28/06/2024 |
| 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="1"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
-NEED FOR STUDY- Autism spectrum disorder (ASD) is
marked by enduring challenges in initiating and maintaining reciprocal social
interactions and communication, coupled with a variety of repetitive and
inflexible behaviors or interests that significantly deviate from typical
norms. With the increasing prevalence of ASD, there is a pressing need for more
focused efforts towards finding effective treatments. This study aims to
explore the potential of Charakoktha Medhya rasayana, a group of medicinal
plants known for their multifaceted benefits, particularly in enhancing memory
and intellect. The research project is designed to investigate the combined use
of internal administration of Medhya vati and external therapeutic procedures,
such as Sarvanga abhyanga with murchita tila taila, followed by pariseka with
balamoola kashaya, Shirodhara with balamoola kashaya, and shirothalam with
Medhya churna mixed with balamoola kashaya, in the management of ASD in
children.
|