| CTRI Number |
CTRI/2021/06/034355 [Registered on: 23/06/2021] Trial Registered Prospectively |
| Last Modified On: |
23/06/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
To analyse the sexual functioning in the SLE female patients |
|
Scientific Title of Study
|
A pilot study on the impact of systemic lupus erythematosus on the sexual functioning of female patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sujitha Reddy |
| Designation |
Junior resident |
| Affiliation |
Kasturba medical college |
| Address |
Room no 21, Department of Dermatology, Kasturba Hospital, Manipal, udupi, Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
7799547701 |
| Fax |
|
| Email |
sujithareddysl@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Varsha M shetty |
| Designation |
Assistant professor |
| Affiliation |
Kasturba medical college |
| Address |
Room no 21, Department of Dermatology, Kasturba Hospital, Manipal, udupi, Karnataka
Udupi
KARNATAKA
575104
India |
| Phone |
9902394514 |
| Fax |
|
| Email |
varshams18@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Varsha M shetty |
| Designation |
Assistant professor |
| Affiliation |
kasturba medical college |
| Address |
Room no 21, Department of Dermatology, Kasturba Hospital, Manipal, udupi, Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9902394514 |
| Fax |
|
| Email |
varshams18@gmail.com |
|
|
Source of Monetary or Material Support
|
| kasturba hospital manipal |
|
|
Primary Sponsor
|
| Name |
Sujitha Reddy |
| Address |
Room no 21, Department of Dermatology, Kasturba Hospital, Manipal, udupi, Karnataka |
| Type of Sponsor |
Other [self] |
|
|
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 |
| sujitha reddy |
kasturba Hospital |
Room no 21,department of dermatology, Kasturba Hospital, Manipal
Udupi
KARNATAKA
Udupi
KARNATAKA |
8247008684
sujithareddysl@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KMC and KH Ethics Comittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L930||Discoid lupus erythematosus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
1. All Women who are above 18 years of age diagnosed to have SLE as per EULAR criteria
2. Women suffering from SLE who report to be sexually active in the past 3 months
3. Women who are willing to participate in the study
|
|
| ExclusionCriteria |
| Details |
1. Women who are not willing to give consent
2. Women with known physical or mental illness affecting sexual health
3. Women on any drugs that is known to interfere with their sexual function
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Sexual function in female SLE patients is measured by FSFI-6.
SLE disease activity is measured by SLEDAI 2K score.
|
2 years
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
23/06/2021 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is an observational study where patients attending the Dermatology department, Kasturba hospital, Manipal have Systemic Lupus Erythematosus. The Association between SLE severity measured by SLEDAI 2K scoring and Female Sexual Function measured by FSFI 6 is measured. |