| CTRI Number |
CTRI/2021/08/035570 [Registered on: 11/08/2021] Trial Registered Prospectively |
| Last Modified On: |
10/08/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To study sexual functioning in psychiatric patients. |
|
Scientific Title of Study
|
Cross-sectional study to assess sexual functioning and marital relationship in male patients with psychiatric disorder. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
AMIT CHOUDHARY |
| Designation |
DNB RESIDENT |
| Affiliation |
BARC MUMBAI |
| Address |
Room number 5 B 176 First floor psychiatry department BARC HOSPITAL ANUSHAKTI NAGAR MUMBAI
Mumbai
MAHARASHTRA
400094
India |
| Phone |
7877155901 |
| Fax |
|
| Email |
dramitchoudhary013@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shobha Nair |
| Designation |
Scientific officer G Consultant psychiatry unit |
| Affiliation |
BARC MUMBAI |
| Address |
Room number 1 B 176 first floor psychiatry department barc hospital Anushakti nagar Mumbai
Mumbai
MAHARASHTRA
400094
India |
| Phone |
7877155901 |
| Fax |
|
| Email |
ssnair@barc.gov.in |
|
Details of Contact Person
Public Query
|
| Name |
AMIT CHOUDHARY |
| Designation |
DNB RESIDENT |
| Affiliation |
BARC MUMBAI |
| Address |
Room number 5 B 176 First floor psychiatry department BARC hospital Anushakti Nagar Mumbai
Mumbai
MAHARASHTRA
400094
India |
| Phone |
7877155901 |
| Fax |
|
| Email |
dramitchoudhary013@gmail.com |
|
|
Source of Monetary or Material Support
|
| BARC Hospital, Anushakti Nagar, Mumbai |
|
|
Primary Sponsor
|
| Name |
BARC |
| Address |
BARC hospital, Anushakti Nagar, Mumbai |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Amit Choudhary |
BARC Hospital |
Dept. Of Psychiatry, 176, room no. 5, first floor, BARCH, Anushakti Nagar, Mumbai, 400094
Mumbai
MAHARASHTRA |
7877155901
dramitchoudhary013@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Medical ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F99||Mental disorder, not otherwise specified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Male |
| Details |
1.Married male patients who are staying with their spouses
2.Clinically stable patients on maintenance treatment for last 6 months.
3.Age less than 60 years |
|
| ExclusionCriteria |
| Details |
1.Individuals with alcohol dependence syndrome, cannabis, opioid
2.Organic brain disorders (e.g. CVA & Dementia)
3.Individuals not willing to |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Prevalence of sexual disorders and dysfunction in individuals with mental health problems |
180 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Treatment of sexual dysfunctions or disorders if any |
180 |
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
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)
|
11/08/2021 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Sexuality is an important aspect of health. Sexual dysfunction is a problem that affects many men. Practice of psychiatrist must include an adequate evaluation of sexual function of all patients. Keeping the above in mind the study aims to assess sexual dysfunction in male patients with mental illnesses attending psychiatry OPD. The study is a cross-sectional design to collect data from male patients. We will enrol 56 male patients with psychiatric illness attending the OPD. The socio demographic factors of patients will be recorded through semi structured proforma. We will also collected details regarding the primary psychiatric illness and psychotropic medications. Using the international index of erectile functioning (IIEF) will be assessed. Assessment of the patient’s relationship with his wife will be assessed using the marital relationship assessment scale. Finally, the results will be documented, analysed and discussed. |