| CTRI Number |
CTRI/2022/02/039889 [Registered on: 01/02/2022] Trial Registered Prospectively |
| Last Modified On: |
19/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Preclinical and clinical evaluation of the siddha classical drug ATHIMADHURA KULIGAI(oral administration) along with KADUGU ENNAI (external application) in the management of AUTISM SPECTRUM DISORDER. |
|
Scientific Title of Study
|
Preclinical and clinical evaluation of effect on oral administration of ATHIMADHURA KULIGAI along with external application KADUGU ENNAI in the management of MAANTHASANNI |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr B Tamil Elakkiya |
| Designation |
II year PG Scholar |
| Affiliation |
Government Siddha Medical College and Hospital |
| Address |
Government Siddha Medical College and Hopsital
Palayamkottai
Tirunelveli
TAMILNADU
INDIA
II year PG Scholar
Government Siddha Medical College and Hopsital
Palayamkottai
Tirunelveli
TAMILNADU
INDIA
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9578169047 |
| Fax |
|
| Email |
balutamilelakkiya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K Shyamala MDs |
| Designation |
Lecturer Grade II |
| Affiliation |
Government Siddha Medical College and Hospital |
| Address |
Government Siddha Medical College and Hopsital
Palayamkottai
Tirunelveli
TAMILNADU
INDIA
Government Siddha Medical College and Hopsital
Palayamkottai
Tirunelveli
TAMILNADU
INDIA
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9442277124 |
| Fax |
|
| Email |
shyamsujisathya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr K Shyamala MDs |
| Designation |
Lecturer Grade II |
| Affiliation |
Government Siddha Medical College and Hospital |
| Address |
Government Siddha Medical College and Hopsital
Palayamkottai
Tirunelveli
TAMILNADU
INDIA
Government Siddha Medical College and Hopsital
Palayamkottai
Tirunelveli
TAMILNADU
INDIA
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9442277124 |
| Fax |
|
| Email |
shyamsujisathya@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Siddha Medical College and Hopsital |
|
|
Primary Sponsor
|
| Name |
DrBTamil Elakkiya |
| Address |
II year PG Scholar
Government Siddha Medical College and Hopsital
Palayamkottai
Tirunelveli
627002.
|
| Type of Sponsor |
Other [self] |
|
|
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 B Tamil Elakkiya |
Government Siddha Medical College and Hospital |
Government Siddha Medical College and Hopsital
Palayamkottai
Tirunelveli
627002.
Tirunelveli
TAMIL NADU |
9578169047
balutamilelakkiya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F840||Autistic disorder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ATHIMADHURA KULIGAI |
1 pill twice a day with honey for 45 days. |
| Intervention |
KADUGU ENNAI |
Thuvalai 45days |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1.Children have lack of eye contact
2.lack of response
3.Repeatative or restricted behaviour
4.Unawareness of natural urges
5.Acquired speech or lost it
6.Unusual senstivity to sensory stimuli |
|
| ExclusionCriteria |
| Details |
1.Children above 12 years
2.Children below 2 years
3.Seevere and recurrent seizures
4.ADHD
5.CP
6.Infantile hemiplegia
7.Congenital anomalies |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Managing clinical symptoms |
45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
03/02/2022 |
| Date of Study Completion (India) |
17/07/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
It is a single arm clinical trial for preclinical and clinical evaluation of the effect on oral administration of ATHIMADHURA KULIGAI along with external application of KADUGU ENNAI in the management of MAANTHASANNI |