| CTRI Number |
CTRI/2025/04/084521 [Registered on: 09/04/2025] Trial Registered Prospectively |
| Last Modified On: |
09/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
THE PREVALENCE OF FUNGAL INFECTIONS IN PATIENTS WITH OBESITY, HIGH BLOOD SUGAR LEVELS , ABNORMAL LIPID PROFILE AND RAISED BLOOD PRESSURE |
|
Scientific Title of Study
|
Metabolic Syndrome among patients having Dermatophytosis- A Hospital based study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shailaja Rathi |
| Designation |
Junior Resident |
| Affiliation |
Shri Ram Murti Smarak Institute of Medical Sciences |
| Address |
Ram Murtipuram,13km, Bareilly-Nainital Rd, Bhojipura, Abheypur Keshonpur, Uttar Pradesh
Room no. 224, F- block,Ram Murtipuram,13km, Bareilly-Nainital Rd, Bhojipura, Abheypur Keshonpur, Uttar Pradesh
Bareilly
UTTAR PRADESH
243202
India |
| Phone |
8380097064 |
| Fax |
|
| Email |
shailrathi123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pratik Gahalaut |
| Designation |
Head of Department |
| Affiliation |
Shri Ram Murti Smarak Institute of Medical Sciences |
| Address |
SRMS,Ram Murtipuram,13km, Bareilly-Nainital Rd, Bhojipura, Abheypur Keshonpur, Uttar Pradesh
F10, Aryan Plaza, Mahanagar colony, Bareilly, Uttar Pradesh-243006
Bareilly
UTTAR PRADESH
243202
India |
| Phone |
9319758004 |
| Fax |
|
| Email |
drpratikg@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shaialja Rathi |
| Designation |
Junior Resident |
| Affiliation |
Shri Ram Murti Smarak Institute of Medical Sciences |
| Address |
Ram Murtipuram,13km, Bareilly-Nainital Rd, Bhojipura, Abheypur Keshonpur, Uttar Pradesh
Room no. 224, F- block,Ram Murtipuram,13km, Bareilly-Nainital Rd, Bhojipura, Abheypur Keshonpur, Uttar Pradesh
Bareilly
UTTAR PRADESH
243202
India |
| Phone |
8380097064 |
| Fax |
|
| Email |
shailrathi123@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. Shailaja Rathi ( self) |
|
|
Primary Sponsor
|
| Name |
SRMS Medical College |
| Address |
Ram Murtipuram,13km, Bareilly-Nainital Rd, Bhojipura, Abheypur Keshonpur, Uttar Pradesh |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Shailaja Rathi |
Ram Murtipuram,13km, Bareilly-Nainital Rd, Bhojipura, Abheypur Keshonpur, Uttar Pradesh |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shaialja Rathi |
SRMS Medical College |
Department Of Dermatology, SRMS Medical College, Ram Murtipuram,13km, Bareilly-Nainital Rd, Bhojipura, Abheypur Keshonpur, Uttar Pradesh
Bareilly
UTTAR PRADESH |
8380097064
shailrathi123@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: L089||Local infection of the skin and subcutaneous tissue, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
METABOLIC SYNDROME AMONG NORMAL POPULATION |
INCIDENCE OF METABOLIC SYNDROME AMONG HEALTHY CONTROLS |
| Comparator Agent |
Metabolic Syndrome among patients having Dermatophytoses |
To find the association of patients having symptoms like obesity, hypertension, high blood glucose and abnormal lipid profile with those infected by fungal infection |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
AGE MORE THAN 18 YEARS.
PATIENT WILLING TO GIVE WRITTEN INFORMED CONSENT.
CLINICALLY DIAGNOSED CASE OF DERMATOPHYTOSIS, CONFIRMED WITH KOH SMEAR. |
|
| ExclusionCriteria |
| Details |
Patient suffering from any chronic systemic disease or cutaneous disorder.
Patient on Systemic Corticosteroids, Immunosuppressants, Lipid lowering agents, Anti-Hypertensive Drugs, Antidiabetic Medications ETC.
Pregnant or lactating patient.
SMOKERS OR ALCOHOLICS. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| PATIENT HAVING METABOLIC SYNDROME HAS ARE INFECTED MORE BY DERMATOPHYTES FOR CHRONIC PERIOD OF TIME. |
MORE THAN 6 MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| PATIENTS HAVING METABOLIC SYNDROME IS SAME IN NORMAL HEALTHY POPULATION AS COMPARED TO CASES |
UNSPECIFIED |
|
|
Target Sample Size
|
Total Sample Size="180"
Sample Size from India="180"
Final Enrollment numbers achieved (Total)= "184"
Final Enrollment numbers achieved (India)="184" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
23/04/2025 |
| Date of Study Completion (India) |
30/09/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
This is a trial to establish a relation between patients having Metabolic Syndrome on the incidence, chronicity and outcome of Dermatophytic Infection in patients. This is a cross sectional study where normal healthy volunteers will be compared with cases having dermatophytic infection on the basis of there blood pressure , waist circumference, lipid profile, fasting blood glucose levels, body mass index. The severity of dermatophytosis in cases will be assessed by dermatophytosis severity scale. The cases will be diagnosed clinically and confirmed with KOH smear. The cases will be compared with controls to determine whether there is a correlation between Dermatophytosis and Metabolic syndrome. |