| CTRI Number |
CTRI/2024/01/061331 [Registered on: 10/01/2024] Trial Registered Prospectively |
| Last Modified On: |
09/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Infection rate of Sexually Transmitted infection in symptomatic women of reproductive age group. |
|
Scientific Title of Study
|
Prevalence of sexually transmitted infections in symptomatic women of reproductive age group in A tertiary care centre |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aruna verma |
| Designation |
Professor in department of obstetrics and gynaecology |
| Affiliation |
Llrm medical college Meerut |
| Address |
LLRM MEDICAL COLLEGE
MEERUT UTTAR PRADESH
Department of obstetrics and gynaecology
LLRM medical college
Meerut Uttar Pradesh
Meerut
UTTAR PRADESH
250004
India |
| Phone |
9997706487 |
| Fax |
|
| Email |
arunaverma36@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aruna verma |
| Designation |
Professor in department of obstetrics and gynaecology |
| Affiliation |
Llrm medical college Meerut |
| Address |
LLRM MEDICAL COLLEGE
MEERUT UTTAR PRADESH
Department of obstetrics and gynaecology
LLRM medical college
Meerut Uttar Pradesh
Meerut
UTTAR PRADESH
250004
India |
| Phone |
9997706487 |
| Fax |
|
| Email |
arunaverma36@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Payal sirohi |
| Designation |
Junior resident |
| Affiliation |
LLRM medical Meerut |
| Address |
FF2 plot 8 Gyan khand2
Indrapuram Ghaziabad
Department of obstetrics and gynaecology
LLRM medical college meerut
Meerut
UTTAR PRADESH
201010
India |
| Phone |
7678623434 |
| Fax |
|
| Email |
Payal2k4s@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of obstetrics and gynaecology
LLRM medical college Meerut |
|
|
Primary Sponsor
|
| Name |
Department of obstetrics and gynaecology LLRM medical college meerut |
| Address |
LLRM medical college meerut |
| Type of Sponsor |
Government medical college |
|
|
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 Payal sirohi |
Department of obstetrics and gynaecology |
Surakshs clinic
Dept of obs and gynaecology
LLRM medical college Meerut
Meerut
UTTAR PRADESH |
7678623434
Payal2k4s@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N70-N77||Inflammatory diseases of female pelvic organs, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Day(s) |
| Age To |
49.00 Day(s) |
| Gender |
Female |
| Details |
Non pregnant women of reproductive age group (18-49 years) with vaginal discharge (other than physiological), with or without associated symptoms.
Patients giving written informed consent to participate in the study and willing for follow up.
|
|
| ExclusionCriteria |
| Details |
• Age <18 or >49 years.
• Bleeding per vaginum at the time of check up.
• Pregnant females.
• Unmarried women with sexual contacts.
• Women who are known cases of chronic disease that might compromise immune system.
• H/O using vaginal cream or vaginal douch.
• Use of oral antibiotics during past 48 hours
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To estimate the prevalence of common STIs (TP, NG, CT, TV, HIV, Syphilis) in women of reproduction age group that is 18-49 years by using specific test for each.
To identify the common signs and symptoms of STI among these women.
To find out the causes and various risk factors of STI.
|
To estimate the prevalence of common STIs (TP, NG, CT, TV, HIV, Syphilis) in women of reproduction age group that is 18-49 years by using specific test for each.
To identify the common signs and symptoms of STI among these women.
To find out the causes and various risk factors of STI.
|
|
|
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)
|
22/01/2024 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
we planned the study to know the prevalence and
causative organism of common STI by doing specific tests to decrease the
overtreatment or missed diagnosis of cervical vaginal infection |