| CTRI Number |
CTRI/2018/03/012844 [Registered on: 26/03/2018] Trial Registered Prospectively |
| Last Modified On: |
01/02/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Finding predisposition to diseases in each temperament |
|
Scientific Title of Study
|
Determination of Udalinan Predisposition to diseases among NIS OPD patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
KALANIDHI D |
| Designation |
PG SCHOLAR |
| Affiliation |
NATIONAL INSTITUTE OF SIDDHA |
| Address |
NATIONAL INSTITUTE OF SIDDHA, TAMBARAM SANATORIUM CHENNAI 47
NATIONAL INSTITUTE OF SIDDHA, TAMBARAM SANATORIUM CHENNAI 47
Chennai
TAMIL NADU
600047
India |
| Phone |
9446530238 |
| Fax |
|
| Email |
kalanidhi900@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
G J CHRISTIAN |
| Designation |
Associate professor |
| Affiliation |
NATIONAL INSTITUTE OF SIDDHA |
| Address |
NATIONAL INSTITUTE OF SIDDHA, TAMBARAM SANATORIUM CHENNAI 47
NATIONAL INSTITUTE OF SIDDHA, TAMBARAM SANATORIUM CHENNAI 47
Chennai
TAMIL NADU
600047
India |
| Phone |
9962545930 |
| Fax |
|
| Email |
christianvijila@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
G J CHRISTIAN |
| Designation |
Associate professor |
| Affiliation |
|
| Address |
NATIONAL INSTITUTE OF SIDDHA TAMBARAM SANATORIUM CHENNAI 47
Chennai
TAMIL NADU
600047
India |
| Phone |
9962545930 |
| Fax |
|
| Email |
christianvijila@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Siddha Hospital |
|
|
Primary Sponsor
|
| Name |
KALANIDHI D |
| Address |
NATIONAL INSTITUTE OF SIDDHA TAMBARAM SANATORIUM CHENNAI 47 |
| 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 |
| KALANIDHI D |
National Institute of Siddha |
NATIONAL INSTITUTE OF SIDDHA,
Department of NoiNaadal
Op num-5
Chennai
TAMIL NADU |
9446530238
kalanidhi900@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMITEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Healthy Human Volunteers |
General |
| Patients |
No specific conditions, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Healthy volunteers
NIS OPD and IPD patients
|
|
| ExclusionCriteria |
| Details |
Mentally retarded patients
Vulnerable groups
Severely ill patients
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Determination of predisposition of a particular type of Udalinan to particular type of diseases |
Determination of predisposition of a particular type of Udalinan to particular type of diseases |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Development of appropriate line of treatment and formulate dietary advice for individual Dhegi type. |
100 |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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)
|
16/04/2018 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
16/04/2018 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Evaluation and standardisation of Udal Ilakkanam based on siddha concepts |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
BACK GROUND
Siddha system explains various diagnostic methods such as Naadi,
Ennvagaithervu examination, Udal ilakkanam, Neikkuri and Neerkkuri etc., among
them Udal ilakkanam helps to identify the predisposition to certain kind of diseases
and response to different kinds of drugs within normal individuals. Every
individual is born with his/her own basic constitution termed as Udalin. The
humour which is predominantly present during the fusion of sukkilam and
suronitham (Karu urpathi) determines the Udalin of that particular individual.
Generally Vali Udalinan, Azhal Udalinan and Iyya Udalinan are called as Thooya
udalinar and combination of mukkutraUdalin is called as kalappu udalinar.
Udalinar
or Dhegi examination is obviously non costly and helps one to know oneself
better and live a healthy and peaceful life. It helps to prevent diseases that
are susceptible for a particular Udalin, there by changing the life style and
dietary regimen.
OBJECTIVES
1)
primary objective
a)
To carry out an open study of predisposition to disease varying predominantly
in each Udalinar
2) Secondary objective
b)
To develop an appropriate line of treatment and dietary regimen after knowing
the Udalinars disease association in patients visiting NIS OPD. |