| CTRI Number |
CTRI/2025/06/089138 [Registered on: 19/06/2025] Trial Registered Prospectively |
| Last Modified On: |
12/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A PROSPECTIVE STUDY ON DIABETES, HYPERTENSON AND OBESITY RISK
FACTORS’ AWARENESS IN GUWAHATI (METRO) CITY, AMONGST
ATTENDANTS OF PATIENTS.
BPOD AWARENESS STUDY. |
|
Scientific Title of Study
|
To evaluate the awareness of risk factors for diabetes, hypertension and obesity in Guwahati city, amongst attendants of patients. |
| Trial Acronym |
BPOD |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Bharat Bhushan Kukreja |
| Designation |
Principal Investigator |
| Affiliation |
Private Clinic |
| Address |
Room no.1, Ground floor, 69/2, S.R.C.B. Road, Fancy Bazar, Guwahati, 781001 (Assam) Room no.1, Ground floor,69/2, S.R.C.B. Road, Fancy Bazar, Guwahati, 781001 (Assam) Kamrup ASSAM 781001 India |
| Phone |
9864093048 |
| Fax |
|
| Email |
bharatkukreja@hotmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr. Bharat Bhushan Kukreja |
| Designation |
Principal Investigator |
| Affiliation |
Private Clinic |
| Address |
Room no.1, Ground floor, Department of Medicine, 69/2, S.R.C.B. Road, Fancy Bazar, Guwahati, 781001 (Assam) Room no.1, Ground floor, Department of Medicine, 69/2, S.R.C.B. Road, Fancy Bazar, Guwahati, 781001 (Assam) Kamrup ASSAM 781001 India |
| Phone |
9864093048 |
| Fax |
|
| Email |
bharatkukreja@hotmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr. Bharat Bhushan Kukreja |
| Designation |
Principal Investigator |
| Affiliation |
Private Clinic |
| Address |
Room no.1, Ground floor,69/2, Department of Medicine, S.R.C.B. Road, Fancy Bazar, Guwahati, 781001 (Assam) Room no.1, Ground floor, Department of Medicine,69/2, S.R.C.B. Road, Fancy Bazar, Guwahati, 781001 (Assam) Kamrup ASSAM 781001 India |
| Phone |
9864093048 |
| Fax |
|
| Email |
bharatkukreja@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Investigator initiated study.
|
|
|
Primary Sponsor
|
| Name |
Dr Bharat Bhushan Kukreja |
| Address |
Room no.1, Ground floor, Department of Medicine, 69/2, S.R.C.B. Road, Fancy Bazar, Guwahati, 781001 (Assam) |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Bharat Bhushan Kukreja |
Dr Bharats clinic |
Dept of Medicine Room no.1, Ground floor,69/2, S.R.C.B. Road, Fancy Bazar, Guwahati, 781001 (Assam) Kamrup ASSAM |
9864093048
bharatkukreja@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ECRC-HEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
-GENERAL POPULATION
-AT RISK POPULATION |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
- Adults aged 10 and above.
- Able to provide informed consent. |
|
| ExclusionCriteria |
| Details |
- Attendant with behavior disorder or attention deficit.
- Person unwilling to provide informed consent. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
The study will enable us to stratazise the usefulness and importance of primary
prevention of NCDs
|
108 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Awareness Levels: Quantifying improvements in public knowledge & awareness
regarding diabetes, hypertension, & overweight. |
108 weeks |
|
|
Target Sample Size
|
Total Sample Size="1000" Sample Size from India="1000"
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)
|
01/07/2025 |
| 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 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [bharatkukreja@hotmail.com].
- For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
The recent findings from ICMR study Indiab on NCDs (Anjana 2011et al.) showing diabetes
11.4%, prediabetes 15.3%, hypertension 35.5%, generalized obesity 28.6% in urban India,
prompted us to design a questionnaire based study amongst the attendants of the patients who
comes for treatment of these clinical conditions.
NCDs being asymptomatic in more than 50% of the population, it is pertinent that awareness and
preventive measures be taken early to highlight the factors which would help health care
providers in defining preventive strategies for primary prevention |