| CTRI Number |
CTRI/2024/05/068027 [Registered on: 29/05/2024] Trial Registered Prospectively |
| Last Modified On: |
28/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
How common is sexual dysfunction among female Lupus Nephritis patients? A study on its prevalence and related factors. |
|
Scientific Title of Study
|
A study to assess the prevalence of sexual dysfunction and its related factors in female patients with Lupus Nephritis at AIIMS,New Delhi |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Arpana Limbu |
| Designation |
Msc Nursing student |
| Affiliation |
AIIMS New Delhi |
| Address |
Porta cabin 2, College of Nursing, All India Institute of Medical Science, Ansari Nagar
South West
DELHI
110029
India |
| Phone |
9534335318 |
| Fax |
|
| Email |
arpanalimbu2403@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ms Cecilia MS |
| Designation |
Associate Professor |
| Affiliation |
AIIMS New Delhi |
| Address |
Room adjacent to room no 9
Ground floor
Department-College of Nursing
Aiims Delhi
Ansari Nagar
South West
DELHI
110029
India |
| Phone |
9899187056 |
| Fax |
|
| Email |
cecilia.aiims@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ms Cecilia MS |
| Designation |
Associate Professor |
| Affiliation |
AIIMS New Delhi |
| Address |
Room adjacent to room no 9, Ground floor, College of Nursing, AIIMS New Delhi Ansari Nagar
Aiims Delhi
South West
DELHI
110029
India |
| Phone |
9899187056 |
| Fax |
|
| Email |
cecilia.aiims@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department-College of Nursing AIIMS Delhi |
|
|
Primary Sponsor
|
| Name |
Arpana Limbu |
| Address |
College of Nursing AIIMS New Delhi Ansari Nagar 110029 |
| 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 |
| Dr Arunkumar S |
AIIMS Delhi |
Room no 4,Porta Cabin, 4th floor
Department of Nephrology Aiims Ansari Nagar
South
DELHI |
9968969076
arunkumar@aiims.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N00-N99||Diseases of the genitourinary system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
The study will include the female lupus nephritis patients who are in reproductive age of 18-45yrs and who can understand either Hindi or English.
|
|
| ExclusionCriteria |
| Details |
The study will exclude the female lupus nephritis patients who are previously diagnosed and treated for sexual dysfunction
who are having chronic illness that could affect their sexual activity
who are on medications that affect Sexual performance (antidepressants, antipsychotics etc)
who are unwilling to provide written informed consent
who are pregnant
who are already diagnosed with mental illness.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the prevalence of sexual dysfunction in female patients with Lupus Nephritis at AIIMS, Delhi
To assess the factors leading to sexual dysfunction in female patients with Lupus Nephritis at AIIMS, New Delhi.
|
baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
01/08/2024 |
| 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="25"
Months="2"
Days="28" |
|
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
|
The WHO (World Health Organization) describes sexual health as a state of physical, emotional, mental and social well-being in relation to sexuality, it is not merely the absence of disease or infirmity. Sexual health plays an essential role in patient’s quality of life and sexual behavior is considered an indispensable part of personal behavior. Several chronic diseases have been reported to negatively affect sexual function, a finding that is frequently neglected. Several studies conducted has reported that females with SLE have high incidence of sexual dysfunction. Since SLE is high among female of childbearing age (15 to 45yrs) thus it is very much necessary to address the sexual dysfunction among this group. Lupus Nephritis denotes a common & severe manifestation of SLE and could be a major factor exerting negative impact on long term renal and patient survival. Renal involvement occurs in up to 60% of adult patients with SLE. Therefore, this study is undertaken to assess the prevalence of sexual dysfunction and its related factors in female lupus nephritis patient instead of Systemic Lupus Erythematosus as a whole. |