| CTRI Number |
CTRI/2024/05/068167 [Registered on: 31/05/2024] Trial Registered Prospectively |
| Last Modified On: |
24/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
DESCRIPTIVE |
| Study Design |
Other |
|
Public Title of Study
|
observational study on siddha diagnostic parameters for clinical prsesentations of type II diabetes |
|
Scientific Title of Study
|
An observational study on assessment of neikuri patterns and other siddha diagnostic parameters for different clinical presentations of madhumegam (Diabetes mellitus) |
| 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 S Susmitha |
| Designation |
PG Scholar |
| Affiliation |
Govt Siddha Medical College and hospital Palayamkottai |
| Address |
Department of Noi naadal
Govt Siddha Medical College and Hospital
Palayamkottai
Tirunelveli
Tirunelveli
TAMIL NADU
627353
India |
| Phone |
9786434153 |
| Fax |
|
| Email |
susmithakala98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S Sundararajan MDS |
| Designation |
Professor and HOD |
| Affiliation |
Govt Siddha Medical College and Hospital Palayamkottai |
| Address |
Department of Noi naadal
Govt Siddha Medical College and Hospital
Palayamkottai
Tirunelveli
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9443423937 |
| Fax |
|
| Email |
soundsundar12@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr S Sundararajan MDS |
| Designation |
Professor and HOD |
| Affiliation |
Govt Siddha Medical College and Hospital Palayamkottai |
| Address |
Department of Noi naadal
Govt Siddha Medical College and Hospital
Palayamkottai
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9443423937 |
| Fax |
|
| Email |
soundsundar12@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government siddha medical college and Hospital, Palayamkottai, tirunelveli,627002 |
|
|
Primary Sponsor
|
| Name |
Government siddha medical college and hospital Palayamkottaii Tirunelveli |
| Address |
Government siddha medical college and hospital Palayamkottai Tirunelveli 627002 |
| 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 Susmitha s |
Government siddha medical college and hospital,Palayamkottai 627002 |
Room no 11, Department of noi naadal,Government siddha medical college and hospital,Palayamkottai,Tirunelveli,627002
Tirunelveli
TAMIL NADU |
9786434153
susmithakala98@mail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instuitional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E11||Type 2 diabetes mellitus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
34.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
patient with or without regular medication for Diabetes mellitus
Patient with HbA1c above 6.5% |
|
| ExclusionCriteria |
| Details |
Age roup below 34 years and above 80 years
lactating women
Gestational diabetes
Diabetes insipidus |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to study the changes in neerkuri and neikuri patterns for the patients with different clinical presentations of type II Diabetes mellitus |
1.5 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessing the naadi nadai and envagai thervugal in type II Diabetes mellitus patients |
1.5 years |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
10/06/2024 |
| 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="6"
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 study is designed to assess the changes in siddha diagnostic procedures especially Neerkuri and Neikuri patterns of different clinical presentations of type II Diabetes mellitus and Assesment of other diagnostic procedure naadi nadai and enavagai thervu, the purpose of the study is to document various neikuri patterns of diabetes mellitus patients |