| CTRI Number |
CTRI/2019/07/020138 [Registered on: 10/07/2019] Trial Registered Prospectively |
| Last Modified On: |
09/07/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Proportion of Diabetic Neuropathy among Type 2 Diabetic Patients-a cross sectional study in Arignar Anna Government Hospital of Indian Medicine |
|
Scientific Title of Study
|
A cross sectional study on Prevalence of Diabetic Neuropathy among Type 2 Diabetic Patients in AAGHIM |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Parwin L |
| Designation |
PG Scholar |
| Affiliation |
Government Siddha Medical College |
| Address |
Post Graduate Department of General Medicine Government Siddha Medical College 6 Anna arch road NSK Nagar Arumbakkam Chennai-600106 Tamilnadu
Chennai
TAMIL NADU
600106
India |
| Phone |
7708756461 |
| Fax |
|
| Email |
parwin1995@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anbu N |
| Designation |
Professor |
| Affiliation |
Government Siddha Medical College |
| Address |
Post Graduate Department of General Medicine Government Siddha Medical College 6 Anna arch road NSK Nagar Arumbakkam Chennai-600106 Tamilnadu
Chennai
TAMIL NADU
600106
India |
| Phone |
9443279412 |
| Fax |
|
| Email |
nanbu.sumi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Parwin L |
| Designation |
PG Scholar |
| Affiliation |
Government Siddha Medical College |
| Address |
Post Graduate Department of General Medicine Government Siddha Medical College 6 Anna arch road NSK Nagar Arumbakkam Chennai-600106 Tamilnadu
Chennai
TAMIL NADU
600106
India |
| Phone |
7708756461 |
| Fax |
|
| Email |
parwin1995@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Siddha Medical College Arumbakkam Chennai 600106 Tamilnadu |
|
|
Primary Sponsor
|
| Name |
Government Siddha Medical College |
| Address |
Government Siddha Medical College 6 Anna arch road NSK Nagar Arumbakkam Chennai-600106 Tamilnadu |
| Type of Sponsor |
Government medical college |
|
|
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 Parwin L |
Arignar Anna Government Hospital of Indian Medicine |
Room no 4c,Diabetic special outpatient Siddha Department 6 Anna arch road NSK Nagar Arumbakkam Chennai 600106 Tamilnadu
Chennai
TAMIL NADU |
7708756461
parwin1995@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 |
(1) ICD-10 Condition: G64||Other disorders of peripheral nervous system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients of both gender with age between 30 to 70 years among Type 2 Diabetic Patients attending outpatient department at Arignar Anna Government Hospital of Indian Medicine Chennai will be included in the study |
|
| ExclusionCriteria |
| Details |
Patients with known history of hyperthyroidism hypothyroidism drug induced neuropathy nutritional deficiency neuropathy will be excluded |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To estimate the prevalence of Diabetic neuropathy among Type 2 Diabetic patients attending outpatient department in Arignar Anna Government Hospital of Indian Medicine Chennai |
90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The current study will be able to determine the impact of an intense lifestyle intervention or neuropathy progression and quality of life in individuals with Diabetic Neuropathy |
90 days |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
16/07/2019 |
| 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) |
Not Yet Recruiting |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
It is a cross sectional study to estimate the prevalence of Diabetic Neuropathy among Type 2 Diabetic patients of both gender with age between 30 to 70 years attending outpatient department at Arignar Anna Government Hospital of Indian Medicine Chennai 600106 Tamilnadu |