| CTRI Number |
CTRI/2023/09/057751 [Registered on: 15/09/2023] Trial Registered Prospectively |
| Last Modified On: |
03/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
clinical evaluation of siddha therapeutic management of sanni kiyazham(Internal) and varmam (External) for Alathidu sanni (ADHD)in children |
|
Scientific Title of Study
|
An open single arm,single centric clinical trial to evaluate the effectiveness of siddha therapeutic management of sanni kiyaazham (internal) and varmam (external) for Alathidu sanni (Attention deficit hypertensive disorder)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 |
Dr M Poovarasi |
| Designation |
PG scholar |
| Affiliation |
National institute of siddha |
| Address |
Room no 16 Department of Kuzhandai maruthuvam
National institute of siddha
Tambaram sanatorium
Kancheepuram
Chennai
600047
India
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9500431829 |
| Fax |
|
| Email |
poovarasi1012@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr P Arulmozhi |
| Designation |
Associate professor |
| Affiliation |
National institute of siddha |
| Address |
Room no 16 Department of Kuzhandai maruthuvam
National institute of siddha
Tambaram sanatorium
Kancheepuram
Chennai
600047
India
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9500151930 |
| Fax |
|
| Email |
drarulmozhi@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr P Arulmozhi |
| Designation |
Associate professor |
| Affiliation |
National institute of siddha |
| Address |
Room no 16 Department of Kuzhandai maruthuvam
National institute of siddha
Tambaram sanatorium
Kancheepuram
Chennai
600047
India
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9500151930 |
| Fax |
|
| Email |
drarulmozhi@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| National institute of siddha
|
|
|
Primary Sponsor
|
| Name |
National institute of siddha |
| Address |
Ayothidoss pandithar hospital
National institute of siddha
Tambaram sanatorium
Kancheepuram
Chennai
600047
India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Drpoovarasi |
Ayothidoss pandithar hospital |
Room no 16 Department of Kuzhandai maruthuvam
National institute of siddha
Tambaram sanatorium
Kancheepuram
Chennai
600047
India
Kancheepuram
TAMIL NADU |
09500431829
poovarasi1012@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, NATIONAL INSTITUTE OF SIDDHA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F902||Attention-deficit hyperactivity disorder, combined type, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
| Intervention |
Sanni kiyaazham
varmam |
internal medicine : Sanni kiyaazham
Dosage :2 to 7 years - 7ml to 18ml
8 to 12 years - 20ml to 25 ml
Duration : 48 days
External therapy :varmam
Duration : 48 days |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Children of age group under 2 - 12 years
Clinically diagnosed as a ADHD
Meet the diagnostic symptoms (any of three)
Lack of concentration
Talking nonstop
Blurting things out
Frequent jumping from one task to another
• Being easily distracted
• Hyperactivity
• Trouble sitting still
• Inability to react to other people’s emotions or feelings
|
|
| ExclusionCriteria |
| Details |
seizure disorder
Cerebral palsy
Autistic spectrum disorder
Auditory and visual processing disorder.
Neurodegenerative disorder.
Post-traumatic head injury.
Post encephalitic disorder. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the effectiveness of sannikiyaazham( internal) & varmam(external)
for the management of AlathiduSanni (Attention deficit Hyperactive Disorder) in children by using
Conner’s parents rating scale & conner’s teachers rating scale. |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/10/2023 |
| Date of Study Completion (India) |
30/04/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 an open clinical study to evaluate the effectiveness of sanni kiyaazham(internal)and varmam(external) for the management of Alathidu sanni(ADHD)in children.It is characterized by symptoms of inattention,overactivity,impulsiveness that are age inappropriate.A sample of 30 subjects (both male and female)with the symptoms of Alathidu sanni (ADHD) who are visiting at national institute of siddha OPD and IPD are to be selected as per inclusion and external criteria.After obtaining consent,the participants will be enrolled in the study.The trial drug will be prepared in the Gunapaadam laboratory,national institute of siddha.the enrolled patients will be treated with trial drug sanni kiyaazham and varmam for 48 days and prognosis will be assessed after 7 days.The data will be analayzed using statistical analysis method.The outcome will be assessed using conner’parents rating scale and conner’s teacher rating scale
|