| CTRI Number |
CTRI/2017/07/009003 [Registered on: 10/07/2017] Trial Registered Retrospectively |
| Last Modified On: |
05/07/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
a study on Siddha diagnostic term of Vathakannagam |
|
Scientific Title of Study
|
a study on symptomatology and diagnostic methodology of Vathakannagam |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Princy B |
| Designation |
PG scholar |
| Affiliation |
NATIONAL INSTITUTE OF SIDDHA |
| Address |
Room no 14
Department of Noinaadal
National Institute of Siddha
Tambaram sanatorium
Room no 14
Department of Noinaadal
National Institute of Siddha
Tambaram sanatorium
Chennai
TAMIL NADU
600047
India |
| Phone |
9585164627 |
| Fax |
|
| Email |
drprincyjan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr G J Christian |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
NATIONAL INSTITUTE OF SIDDHA |
| Address |
Department of Noinaadal
National Institute of Siddha
Tambaram sanatorium
Department of Noinaadal
National Institute of Siddha
Tambaram sanatorium
Chennai
TAMIL NADU
600047
India |
| Phone |
9962545930 |
| Fax |
|
| Email |
christianvijila@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr B Princy |
| Designation |
PG scholar |
| Affiliation |
NATIONAL INSTITUTE OF SIDDHA |
| Address |
Room no 14
Department of Noinaadal
National Institute of Siddha
Tambaram sanatorium
Room no 14
Department of Noinaadal
National Institute of Siddha
Tambaram sanatorium
Chennai
TAMIL NADU
600047
India |
| Phone |
9585164627 |
| Fax |
|
| Email |
drprincyjan@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
National Institute of Siddha |
| Address |
National Institute of Siddha
Tambaram sanatorium
Chennai |
| 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 |
| Princy B |
National Institute of Siddha |
Room no 14
Department of Noinaadal
National Institute of Siddha
Tambaram sanatorium
Chennai 600047
Chennai
TAMIL NADU |
9585164627
drprincyjan@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 |
UNSTEADYNESS DURING WALING, CLIMBING UP AND DOWN THE STAIRS, LATERALLY SLIPPING DURING WALKING,WEEKNESS IN WHOLE BODY AND WIDE BASED GAIT, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Unsteadiness during walking, climbing up and dowm the stairs, laterally slipping during walking, weakness in whole body and wide gait.
|
|
| ExclusionCriteria |
| Details |
Parkinsonism
Stroke
Alcoholism
Hypothyroidism
Multiple sclerosis
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Establishing the relevance / correlation Sage Yugi symptomatology with that of modern concept of Cerebellar ataxia |
Establishing the relevance / correlation Sage Yugi symptomatology with that of modern concept of Cerebellar ataxia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Arriving at concepts of the Siddha pathophysiology of Vaatha Kannagam
Finalizing the line of treatment, dietary regimen for Vaatha Kannagam
Elucidation of Siddha investigatory parameters of Envagai thervu, in the diagnosis of
Vaatha Kannagam
|
1 MONTH |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
17/04/2017 |
| 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="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Siddha medicine is one of the ancient system of medicine. According to Siddha system of medicine Vathakannagam comes under Vatha diseases. Vathakannagam has been discribed by sage yugi in his text of Yugi Vaidya Chindamani. This may be include unsteadiness during walking, climbing up and down the stairs due to motor incoordination. Laterally slipping during walking, weakness in whole body and wide based gait. Vathakannagam closely resembles the condition cerebellar ataxia in modern medicine. |