| CTRI Number |
CTRI/2024/10/075643 [Registered on: 22/10/2024] Trial Registered Prospectively |
| Last Modified On: |
22/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
to study the presence and causes of sexual dysfunction in patients having chronic kidney disease |
|
Scientific Title of Study
|
DETERMINANTS AND PREVALENCE OF SEXUAL DYSFUNCTION IN PATIENTS WITH RENAL FAILURE |
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sourabh Sharma |
| Designation |
Associate Professor, Dept of Nephrology |
| Affiliation |
VMMC Safdarjung Hospital |
| Address |
Nephrology OPD, Department of Nephrology, Super Speciality Block, Ansari Nagar East, Opposite AIIMS
New Delhi
DELHI
110029
India |
| Phone |
9599702038 |
| Fax |
|
| Email |
drsourabh05@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Varun Kumar Bandi |
| Designation |
Associate Professor |
| Affiliation |
Dr. Pinnamaneni Siddhartha Institue of Medical Sciences and RF |
| Address |
Room 212, Second Floor, Super Speciality Block, Pinnamaneni Siddhartha Hospital, Chinna Avutapalli
Krishna
ANDHRA PRADESH
521286
India |
| Phone |
7708396309 |
| Fax |
|
| Email |
varun.vims@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Varun Kumar Bandi |
| Designation |
Associate Professor |
| Affiliation |
Dr. Pinnamaneni Siddhartha Institue of Medical Sciences and RF |
| Address |
Room 212, Second Floor, Super Speciality Block, Pinnamaneni Siddhartha Hospital, Chinna Avutapalli
Krishna
ANDHRA PRADESH
521286
India |
| Phone |
7708396309 |
| Fax |
|
| Email |
varun.vims@gmail.com |
|
|
Source of Monetary or Material Support
|
| Primary Sponsor - Investigator,
Dr. Varun Kumar Bandi
Room 212, Second Floor, Super Speciality Block, Pinnamaneni Siddhartha Hospital, Chinna Avutapalli, Krishna District, Andhra Pradesh, India - 521286 |
|
|
Primary Sponsor
|
| Name |
Dr Varun Kumar Bandi |
| Address |
Primary Sponsor - Investigator,
Dr. Varun Kumar Bandi
Room 212, Second Floor, Super Speciality Block, Pinnamaneni Siddhartha Hospital, Chinna Avutapalli, Krishna District, Andhra Pradesh, India - 521286 |
| 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 Varun Kumar Bandi |
Dr Pinnamaneni Siddhartha Institute of Medical Sciences and RF |
Primary Sponsor - Investigator,
Dr. Varun Kumar Bandi
Room 212, Second Floor, Super Speciality Block, Pinnamaneni Siddhartha Hospital, Chinna Avutapalli, Krishna District, Andhra Pradesh, India - 521286
Krishna
ANDHRA PRADESH |
7708396309
varun.vims@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr. Pinnamaneni Siddhartha Institute of Medical Sciences and Research Foundation |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N18||Chronic kidney disease (CKD), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. Age more than 18 years
2. Presence of Chronic Kidney Disease
3. Patients consenting for the study
|
|
| ExclusionCriteria |
| Details |
1. Pregnant Women
2. People not consenting for study
3. Participation in any other clinical trial
4. Patients with critical illness
5. Patients not deemed fit for sexual activity by the treating physician
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the prevalence of sexual dysfunction in patients with chronic kidney disease |
Baseline and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Progression of CKD |
6 months |
|
|
Target Sample Size
|
Total Sample Size="700"
Sample Size from India="700"
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)
|
31/10/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
31/10/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="5"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
All patients with chronic kidney disease presenting to the Department of Nephrology will be evaluated for inclusion in the study. Patient’s demographic characteristics, such as Age, Gender, presence, and duration of co-morbidities, will be noted. The subject’s blood pressure, Hemoglobin, Random blood sugar, Creatinine, serum calcium, phosphorous, uric acid, serum albumin, bicarbonate, and intact parathyroid hormone levels will be done at baseline and reports noted. The patient’s eGFR (Glomerular Filtration Rate) will be calculated using the CKD-EPI equation and will be rounded off to the closest whole number. CKD will be staged based on KDIGO criteria. Sexual dysfunction in men will be assessed using 15-item International Index of Erectile Function (IIEF), and using Female Sexual Function Index (FSFI) Scoring in women. The scoring of the questionnaires will be done using approved scoring systems. |