| CTRI Number |
CTRI/2019/07/020131 [Registered on: 10/07/2019] Trial Registered Prospectively |
| Last Modified On: |
30/11/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effectiveness of Varmam therapy and Karuppu vishnu chakkara maathirai(Siddha medicine)in Epilepsy |
|
Scientific Title of Study
|
A Comparative clinical trial on efficacy of Varmam therapy and Karuppu vishnu chakkara maathirai (internally) in the management of Kakkaivalippu (Epilepsy) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vrindha K V |
| Designation |
P G Scholar |
| Affiliation |
National Institute of Siddha |
| Address |
Department of Varma Maruthuvam,National Institute of Siddha,Tambaram sanatorium,Chennai 600047,Tamilnadu,India
Chennai
India
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
8547310412 |
| Fax |
|
| Email |
vrindhakv24@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr N J Muthukumar |
| Designation |
Professor |
| Affiliation |
National Institute of Siddha |
| Address |
Department of Sirappu Maruthuvam,National Institute of Siddha,Tambaram sanatorium,Chennai 600047,Tamilnadu,India
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9444206843 |
| Fax |
|
| Email |
njmuthu@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vrindha K V |
| Designation |
P G Scholar |
| Affiliation |
National Institute of Siddha |
| Address |
Department of Varma Maruthuvam,National Institute of Siddha,Tambaram sanatorium,Chennai 600047,Tamilnadu,India
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
8547310412 |
| Fax |
|
| Email |
vrindhakv24@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Siddha,Tambaram sanatorium,Chennai-47,Tamilnadu |
|
|
Primary Sponsor
|
| Name |
Ayothidoss Pandithar Hospital |
| Address |
National Institute of Siddha,Tambaram sanatorium,Chennai 600047 |
| 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 |
| Dr Vrindha K V |
Ayothidoss Pandithar Hospital |
Room no :3 ,Department of Varma maruthuvam, National I nstitute of Siddha,Tambaram sanatorium,Chennai 600047
Kancheepuram
TAMIL NADU
Kancheepuram
TAMIL NADU |
8547310412
vrindhakv24@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G00-G99||Diseases of the nervous system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Karuppu vishnu chakkaram maathirai
Varmam therapy |
varmam is a special therapy
Karuppu vishnu chakkara mathirai is an internal medicine |
| Comparator Agent |
Varmam therapy |
it is a special therapy |
| Comparator Agent |
Varmam therapy |
Special therapy |
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Blinking and upward rolling of eyes
Stare blankly
Repeated jerky movements of face neck arms
Brief muscle jerk singly or in series involving single or multiple muscles
Loss of awareness
Loss of consciousness
Disturbances in movement and sensation
|
|
| ExclusionCriteria |
| Details |
Patients with uncontrolled Hypertension and diabetes mellitus
Secondary epilepsy due to severe brain injury brain tumour stroke congenital brain malformations
Status epilepticus
Hysterical seizures
Pregnancy and lactation
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Outcome will be based on decrease in seizure episode and duration |
After 45 days from starting date outcome will be measured |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Study the siddha basic principles
To know the incidence of epilepsy in different age group |
12 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
01/08/2019 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/08/2019 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="11"
Days="30" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Study report will publish in reputed journal |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
It is a comparative clinical trial on kakkaivalippu noi(epilepsy) to know the effectiveness of varmam therapy and karuppu vishnuchakkara mathirai(internal medicine) 30 patients will be recruited for this study study place is opd of national institute of siddha |