| CTRI Number |
CTRI/2024/06/069064 [Registered on: 18/06/2024] Trial Registered Prospectively |
| Last Modified On: |
12/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha
Screening
Behavioral |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
clinical study using siddha medicine for Autism spectrum disorder |
|
Scientific Title of Study
|
Phase II Non Randomized Clinical Study In The Management Of Maantha Sanni (Autism Spectrum Disorder) With The Validation Of Siddha Trial Drug Maantha Kuligai As Internal Medicine And Sanni Maantha Pugai As (External) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr M Soundarya |
| Designation |
PG Scholar |
| Affiliation |
Government Siddha Medical College Arumbakkam Chennai 106 |
| Address |
Post graduate Room No 25 Department of Kuzhanthai Maruthuvam
Government Siddha Medical College Arumbakkam Chennai
Chennai
Tamilnadu
600106
India
Chennai
TAMIL NADU
106
India |
| Phone |
7708196249 |
| Fax |
|
| Email |
soundaryamoorthy1998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr C Shanmuga Priya |
| Designation |
Lecturer |
| Affiliation |
Government Siddha Medical College Arumbakkam Chennai 106 |
| Address |
Post graduate Room No 25 Department of Kuzhanthai Maruthuvam
Government Siddha Medical College Arumbakkam Chennai
Chennai
Tamilnadu
600106
India
Chennai
TAMIL NADU
106
India |
| Phone |
9445661808 |
| Fax |
|
| Email |
cspriya2004@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr C Shanmuga Priya |
| Designation |
Lecturer |
| Affiliation |
Government Siddha Medical College Arumbakkam Chennai 106 |
| Address |
Post graduate Room No 25 Department of Kuzhanthai Maruthuvam
Government Siddha Medical College Arumbakkam Chennai
Chennai
Tamilnadu
600106
India
Chennai
TAMIL NADU
106
India |
| Phone |
9445661808 |
| Fax |
|
| Email |
cspriya2004@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Siddha Medical College,
Arumbakkam
Chennai 600106
TAMILNADU
INDIA |
|
|
Primary Sponsor
|
| Name |
Government Siddha Medical College |
| Address |
No 6 Anna Arch Road NSK Nagar Arumbakkam Chennai 600106 |
| Type of Sponsor |
Government 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 M Soundarya |
Government Siddha Medical College |
Room No 25
Department of Kuzhanthai Maruthuvam
Arignar Anna Government Hospital NSK Nagar
Arumbakkam
Chennai
TAMILNADU
Chennai
TAMIL NADU |
7708196249
soundaryamoorthy1998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Maantha Kuligai (internal) and Sanni Maantha Pugai(external) |
Maantha Kuligai 1( 145mg)-to 2(290mg) tablet(kuligai) with Hotwater twice a day for 48 days and External Fumigation of Sanni Maantha Pugai for 48 days |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Children have lack of eye contact
Lack of response
Repetitive and restrictive behavior
Unawareness of natural urges
Acquired speech or lost it
Unusual sensitive to sensory stimuli |
|
| ExclusionCriteria |
| Details |
Children above 12 years
Children below 2 years
Severe and recurrent seizure
ADHD
Cerebral palsy
Infantile hemiplegia
Congenital anomalies |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| It is mainly assessed by reduction in clinical symptoms |
48 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| it is assessed by comparing sensory function connecting parameters social interactions adaptive behavior language communication domains |
48 Days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
03/10/2024 |
| 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="0"
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
|
This is a Single Non-Randomized Open Clinical Trial to Study the Safety and Efficacy of Siddha Trial Drug Maantha Kuligai(internal) is to be given about 1(145mg) to 2 (290mg) (Thuvarai alavu) tablet(kuligai) with hotwater twice a day for 48 daysand External Fumigation of Sanni Maantha Pugai for 48 days. clinical trial conducted after conducting preclinical study.The Trial drug Maantha Kuligai mentioned in Bala vaithiya thirattu and Saani Maantha Pugai mentioned in Pillai Pini Maruthuvam part 2. During the trial the study related data will be recorded and documented.After the completion of trial all data will be statistically analyzed.
|