| CTRI Number |
CTRI/2024/08/073126 [Registered on: 29/08/2024] Trial Registered Prospectively |
| Last Modified On: |
20/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Burden of diabetic neuropathy among Diabetes Mellitus patients attending NIUM hospital : A cross sectional study |
|
Scientific Title of Study
|
Prevalence of Diabetic Neuropathy among the
Patients of Dhayabitus attending NIUM Hospital
A Cross Sectional Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Umme Saba Anjum |
| Designation |
PG Scholar |
| Affiliation |
National Institute Of Unani Medicine |
| Address |
Department of tahafuzzi wa samaji tib, National Institute Of Unani Medicine, Kottigepalya, Magadi Main Road Bangalore KARNATAKA -560091 India
Bangalore
KARNATAKA
560091
India |
| Phone |
8660011738 |
| Fax |
|
| Email |
sababutul9@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Abdul Haseeb Ansari |
| Designation |
Professor |
| Affiliation |
National Institute Of Unani Medicine |
| Address |
Department of tahafuzzi wa samaji tib, National Institute Of Unani Medicine, Kottigepalya, Magadi Main Road Bangalore KARNATAKA -560091 India
Bangalore
KARNATAKA
560091
India |
| Phone |
9448258140 |
| Fax |
|
| Email |
ahansari001@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Umme Saba Anjum |
| Designation |
PG Scholar |
| Affiliation |
National Institute Of Unani Medicine |
| Address |
Department of tahafuzzi wa samaji tib, National Institute Of Unani Medicine, Kottigepalya, Magadi Main Road Bangalore KARNATAKA -560091 India
Bangalore
KARNATAKA
560091
India |
| Phone |
8660011738 |
| Fax |
|
| Email |
sababutul9@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD -03 Department of tahafuzzi wa samaji tib , National Institute Of Unani Medicine kottigepalya main road Bangalore karnataka India-560091 |
|
|
Primary Sponsor
|
| Name |
National Institute Of Unani Medicine |
| Address |
Department Of Tahaffuzi wa samaji tib,National Institute Of Unani Medicine, kottigepalya Magadi main road Bangalore karnataka India-560091 |
| 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 Umme Saba Anjum |
National Institute Of Unani Medicine |
Department Of Tahaffuzi wa samaji tib,National Institute Of Unani Medicine, kottigepalya Magadi main road Bangalore karnataka India-560091
Bangalore
KARNATAKA |
8660011738
sababutul9@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Communication Of Decision of the institutional Ethics Committee (IEC) for Biomedical Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E114||Type 2 diabetes mellitus with neurological complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients are having Diabetes Mellitus for more than 2 years.
2.Patients of Diabetes Mellitus between the age group of 30-60 years.
3.Patients of either gender. |
|
| ExclusionCriteria |
| Details |
1.Patients other than Diabetes Mellitus
2.Patients who do not cooperate/not willing
3.Patients below the age of 30 years and above 60 years. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To know the prevalence of diabetic neuropathy among the patients of
DhayÄbÄ«á¹us, attending NIUM Hospital. |
0 DAYS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To make the patients & their attendants aware about diabetes & its complication |
0 day |
|
|
Target Sample Size
|
Total Sample Size="230"
Sample Size from India="230"
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)
|
02/09/2024 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Diabetic neuropathy is the most prevalent consequence of DM, and if it is not
appropriately treated within a reasonable amount of time, it may become more
complicated. Initially, there will be pain, in the second stage pain and numbness are
more consistent, third stage pain is unbearable and numbness can become so severe
that results in loss of sensation in the affected nerves which puts them at risk of
getting burns and cuts unknowingly. These injuries can lead to severe infections
such as sepsis, foot ulcers and gangrene, and there will be permanent nerve damage
and become very numb, resulting in amputation, leading to reduce quality of life,
and it is attributable to the morbidity and mortality associated with diabetic
neuropathy.This is the conclusion reached by all past studies and research. For this
purpose, the awareness study is essential, I, therefore, intend to carry out this
research, which aims to screening and early detection of diabetic neuropathy,
therefore, offers a crucial opportunity for patients with diabetes to actively alter the
course of suboptimal glycaemic control to recommend level. Currently, the mainstay
of management is to control the risk factor of diabetic neuropathy and manage its
complications and is essential to make an early and accurate diagnosis so that the
measures to reduce the risk of its complications may be implemented and improve
quality of life among diabetic patients, also to create awareness among the patients
about its adverse effect. Additionally, this research may be useful in ensuring that
patients and their relatives receive appropriate direction and quality education. On
the basis of this study, researchers may also be able to suggest forming prevention
plans and advise proper exercise, lifestyle change strategies and therapeutic impact
on patients of diabetes and they also may be able to formulate better management
plans for the care, and its consequence such as diabetic neuropathy, so that the
person with diabetes can once again bloom like a flower and resume their pre-illness
state. |