| CTRI Number |
CTRI/2018/02/011885 [Registered on: 13/02/2018] Trial Registered Retrospectively |
| Last Modified On: |
13/02/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Proportion of diabetes patients suffering from sexual dysfunction |
|
Scientific Title of Study
|
Prevalence of erectile dysfunction among patients with diabetes mellitus- A cross sectional study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Arnab Sarkar |
| Designation |
DNB resident |
| Affiliation |
Bangalore Baptist Hospital |
| Address |
Community health department
Bangalore Baptist Hospital
Bellary Road Hebbal Bangalore
Bangalore
KARNATAKA
560024
India |
| Phone |
9739321812 |
| Fax |
|
| Email |
neusci4@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrGift Norman |
| Designation |
HOD Community Health Department |
| Affiliation |
Bangalore Baptist Hospital |
| Address |
Community health department
Bangalore Baptist Hospital
Bellary Road Hebbal Bangalore
Bangalore
KARNATAKA
560024
India |
| Phone |
9591761106 |
| Fax |
|
| Email |
normangift@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrGift Norman |
| Designation |
HOD Community Health Department |
| Affiliation |
Bangalore Baptist Hospital |
| Address |
Community health department
Bangalore Baptist Hospital
Bellary Road Hebbal Bangalore
Koppal
KARNATAKA
560024
India |
| Phone |
9591761106 |
| Fax |
|
| Email |
normangift@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bangalore Baptist Hospital
Bellary road hebbal bangalore-560024 |
|
|
Primary Sponsor
|
| Name |
Bangalore Baptist Hospital |
| Address |
Bangalore Baptist Hospital Bellary road Hebbal Bangalore |
| 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 |
| Arnab Sarkar |
Bangalore Baptist Hospital |
Department of community medicine
Bangalore Baptist Hospital,
Bellary road,
Hebbal,
Bangalore.
Bangalore
KARNATAKA |
9739321812
necesci4@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional review Board Bangalore Baptist Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Diabetes mellitus, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Male |
| Details |
Diagnosed to have diabetes mellitus (HbA1c > 6.5 or FBS >126 or PPBS >200 ) for at least one year.
Age 25-60 years old.
Married or having partner in a stable relationship for at least the past 6 months.
|
|
| ExclusionCriteria |
| Details |
Any structural or congenital abnormalities of genital organs.
Any infectious disease of the genital organs which can interfere with sexual activity.
Post traumatic fibrosis of genitals.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Prevalence of erectile dysfunction. |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Determinants of erectile dysfunction. |
1 year |
|
|
Target Sample Size
|
Total Sample Size="180"
Sample Size from India="180"
Final Enrollment numbers achieved (Total)= "180"
Final Enrollment numbers achieved (India)="180" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/02/2015 |
| Date of Study Completion (India) |
23/05/2016 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="1" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
"none yet" |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Background : Erectile dysfunction(ED) one of the most common complication of diabetes mellitus(DM) and one of the most under diagnosed.ED is almost 2 to 3 times more common among diabetics than non diabetics.The incidence of DM is increasing in alarming rate with a corresponding increase in sexual dysfunction in them.ED ,a distressing problem,has a significant negetive impact on quality of life of patients and their partners.Despite this health care provider do not specifically ask about this leading to considerable underdiagnosis.The prevalence of ED among DM patients is high and to be increasing day by day. Materials & Methods:Patients attending the primary care clinic (rural &urban) conducted by community health dept. of Bangalore Baptist Hosptal and OPD in Bangalore Baptist hospital who fulfills following criteria were requested to join the study.Male aged between 25 and 60 with known diabetes for at least 1 year and in stable relations for at least past 6 mo. Its a cross sectional study with a sample size of 200 assuming a prevalence of30 %
|