| CTRI Number |
CTRI/2024/06/069523 [Registered on: 26/06/2024] Trial Registered Prospectively |
| Last Modified On: |
20/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Frequency of various sexually transmitted infections in rural health care facility attendees |
|
Scientific Title of Study
|
Spectrum and predictors of select sexually transmitted infections among individuals attending a rural health care facility |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
NELUVIGI NARASIMHAMURTHY |
| Designation |
POST GRADUATE RESIDENT |
| Affiliation |
Maulana Azad Medical College, New Delhi |
| Address |
ROOM NO 39 DEPARTMENT OF MICROBIOLOGY PATHOLOGY BLOCK MAULANA AZAD MEDICAL COLLEGE, NEW DELHI
Central
DELHI
110002
India |
| Phone |
8722916123 |
| Fax |
|
| Email |
narasimhamurthy.624@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rohit Chawla |
| Designation |
Professor |
| Affiliation |
Maulana Azad Medical College, New Delhi |
| Address |
Room no 40, Department of Microbiology Pathology block, Maulana Azad Medical College, New Delhi
Central
DELHI
110002
India |
| Phone |
9810079074 |
| Fax |
|
| Email |
rohitchawla75@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rohit Chawla |
| Designation |
Professor |
| Affiliation |
Maulana Azad Medical College, New Delhi |
| Address |
Room no 40, Department of Microbiology Pathology block, Maulana Azad Medical College, New Delhi
Central
DELHI
110002
India |
| Phone |
9810079074 |
| Fax |
|
| Email |
rohitchawla75@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College and Lok Nayak Hospital
Bahadur Shah Zafar Marg, near Delhi Gate Maulana Azad Medical College campus, Balmiki Basti, New Delhi, India, 110002 |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College and Lok Nayak Hospital |
| Address |
Department of Microbiology Pathology block, Maulana Azad Medical College, New Delhi 110002 India |
| 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 |
| Neluvigi Narasimhamurthy |
Rural Health Training Center Barwala |
Sector 35 Rohini Delhi 110039
North West
DELHI |
8722916123
narasimhamurthy.624@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethical Committee Maulana Azad Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A64||Unspecified sexually transmitted disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
59.00 Year(s) |
| Gender |
Both |
| Details |
All the individuals between 18-59 years attending RHTC Barwala. |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of study subjects with symptoms and/or aetioligical diagnosis of STIs. |
1 YEAR |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Spectrum of STIs among study subjects. |
1 YEAR |
| Risk factors associated with STIs among study subjects |
1 YEAR |
|
|
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)
|
10/07/2024 |
| 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
|
The study entitled "Spectrum and Predictors of select Sexually Transmitted Infections among individuals attending a rural health care facility" will be conducted at Department of Microbiology Maulana Azad Medical College in collaboration with rural health training center Barwala. Only after proper consent blood and urine sample will be taken for ELISA, multiplex PCR, VDRL/RPR and TPHA. |