| CTRI Number |
CTRI/2024/12/078508 [Registered on: 24/12/2024] Trial Registered Prospectively |
| Last Modified On: |
23/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To assess the Knowledge,Awareness and use of artificial sweeteners among type 2 diabetic patients aged 45 to 65 years |
|
Scientific Title of Study
|
Knowledge and awareness on usage of artificial sweeteners among Indian Type 2 Diabetic patients aged 45 to 65 years |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anam Hasham Khan |
| Designation |
Student |
| Affiliation |
Dr BMN College of Home Science |
| Address |
MSC CND -2
Dr BMN College of Home Science 338, Rafi Ahmed Kidwai Rd, Matunga East, Mumbai
Mumbai (Suburban)
MAHARASHTRA
400019
India |
| Phone |
9969133330 |
| Fax |
|
| Email |
khananamhasham01@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anuradha Shekar |
| Designation |
Retired Associate Professor |
| Affiliation |
Dr BMN College of Home Science |
| Address |
MSC CND 2
Dr BMN College of Home Science, 338, Rafi Ahmed Kidwai Rd, Matunga East, Mumbai
MSC CND 2
Dr BMN College of Home Science, 338, Rafi Ahmed Kidwai Rd, Matunga East, Mumbai
Mumbai
MAHARASHTRA
400019
India |
| Phone |
9820617577 |
| Fax |
|
| Email |
shekaranuradha237@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anuradha Shekar |
| Designation |
Retired Associate Professor |
| Affiliation |
Dr BMN College of Home Science |
| Address |
MSC CND 2
Dr BMN College Of Home Science, 338, Rafi Ahmed Kidwai Rd, Matunga East, Mumbai
MSC CND 2
Dr BMN College Of Home Science, 338, Rafi Ahmed Kidwai Rd, Matunga East, Mumbai
Mumbai
MAHARASHTRA
400019
India |
| Phone |
9820617577 |
| Fax |
|
| Email |
shekaranuradha237@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr BMN College Of Home Science 338, Rafi Ahmed Kidwai Rd, Matunga East, Mumbai 400019, India |
|
|
Primary Sponsor
|
| Name |
Anam Hasham Khan |
| Address |
Dr.BMN College of Home Science 338, Rafi Ahmed Kidwai Rd, Matunga East, Mumbai, Maharashtra 400019, India |
| Type of Sponsor |
Other [Self sponsored ] |
|
|
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 Vijay Panikar |
Dr Vijay K Panikar- Speciality care centre |
Siddhant CHS, behind Guru Nanak Hospital, next to JAGAT VIDYA, C.H.S, Bandra East, Mumbai, Maharashtra 400058
Mumbai
MAHARASHTRA |
02226570941
drpanikar.speciality@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Seva Mandal Educational Society Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
N/A |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Type 2 diabetes patients
Willing to Participate
Not more than the age mentioned
|
|
| ExclusionCriteria |
| Details |
Disabled
Type 1 Diabetes patients
Medically ill
Not giving any consent
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
In this study we will understand about the knowledge , awareness on usage of artificial sweeteners among Type 2 diabetic patients and factors influencing their choices
|
10 MONTHS
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
In this study we will understand about the knowledge , awareness on usage of artificial sweeteners among Type 2 diabetic patients & factors influencing their choices
|
10 months |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
03/01/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
03/01/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="10"
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
|
1) To Assess the knowledge and use of artificial sweeteners among type 2 diabetic patients 2) To evaluate awareness of different artificial sweeteners available 3) To Analyse the usage pattern of artificial sweeteners among type 2 diabetic patients |