| CTRI Number |
CTRI/2025/10/096602 [Registered on: 29/10/2025] Trial Registered Prospectively |
| Last Modified On: |
28/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Syphilis in Our Community: What the Hospital Data Shows |
|
Scientific Title of Study
|
Clinico-Epidemiological Profile of Syphilis 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 |
Munazzah Khan |
| Designation |
Junior resident |
| Affiliation |
Maulana Azad Medical College |
| Address |
JR room, ward 22, Department of Dermatology, Lok Nayak Hospital, Delhi
Central
DELHI
110002
India |
| Phone |
8448278558 |
| Fax |
|
| Email |
drmunazzahkhan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Krishna Deb Barman |
| Designation |
Director Professor and HOD |
| Affiliation |
Maulana Azad Medical College |
| Address |
Ward 22. Department of Dermatology, STD and Leprosy
Maulana Azad Medical College and Associated Lok Nayak Hospital
Central
DELHI
110002
India |
| Phone |
9868961716 |
| Fax |
|
| Email |
kdebbarman@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Munazzah Khan |
| Designation |
Junior resident |
| Affiliation |
Maulana Azad Medical College |
| Address |
JR room, ward 22, Department of Dermatology, Lok Nayak Hospital, Delhi
Central
DELHI
110002
India |
| Phone |
8448278558 |
| Fax |
|
| Email |
drmunazzahkhan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Lok Nayak Hospital.
Bahadurshah Zafar Marg, Ito, Delhi - 110002 |
|
|
Primary Sponsor
|
| Name |
Lok Nayak Hospital |
| Address |
Bahadurshah Zafar Marg, Ito, Delhi - 110002
|
| 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 Munazzah Khan |
Maulana Azad Medical College and associated hospitals, New Delhi. |
7th floor OPD. Department of Dermatology, STD and Leprosy
Maulana Azad Medical College and Associated Lok Nayak HospitaL, Delhi 110002
Central
DELHI |
08448278558
drmunazzahkhan@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: A51||Early syphilis, (2) ICD-10 Condition: A528||Late syphilis, latent, (3) ICD-10 Condition: A539||Syphilis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Clinically and/or serologically diagnosed cases of syphilis.
Age more than 18 years.
|
|
| ExclusionCriteria |
| Details |
False-positive serology (defined as a positive non-treponemal test with a negative treponemal test, along with the absence of signs and symptoms of syphilis)
Congenital syphilis.
Patients previously treated for syphilis.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| demographic variables (e.g., age, gender, sexual practices, risk factors and stage of syphilis)- percentage, mean, medians. Distribution of clinical presentations and stages. |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Correlation between specific dermoscopic features & histopathological findings in the lesions of primary & secondary syphilis |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
09/11/2025 |
| 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 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 Aim of the thesis is
to study the clinico-epidemiological profile of syphilis. Primary
objective is to determine the demographical profile and clinical patterns of
syphilis in a tertiary care hospital, while the secondary objective is to study
histopathological and dermoscopic findings in the skin lesions of primary and
secondary syphilis.
All cases with positive
non-treponemal and treponemal tests or negative non-treponemal tests with
positive treponemal tests, with or without strong suspicion of syphilis, will
be considered as case of the trial.
|