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CTRI Number  CTRI/2025/12/099145 [Registered on: 15/12/2025] Trial Registered Prospectively
Last Modified On: 15/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Unani
Other (Specify) [amraze jild wa tazeeniyat]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing a Unani oral and topical treatment with Clotrimazole lotion for the management of steroid modified fungal infection. 
Scientific Title of Study   Efficacy of Joshanda Mussaffi orally with local application of Tila versus Clotrimazole 1% lotion in Tinea Incognito–A Single Blind Randomized Controlled Trial. 
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 khan shahina bano mohd vakeel 
Designation  pg scholar 
Affiliation  national institute of unani medicine 
Address  National Institute of Unani Medicine Kottigepalya Magadi Main Road Bangalore KARNATAKA 560091 India

Bangalore
KARNATAKA
560091
India 
Phone  9321769306  
Fax    
Email  khanshahina101@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Mohd Aleemuddin Quamri  
Designation  HoD -Dept. of Amraze Jild wa Tazeeniyat 
Affiliation  national institute of unani medicine 
Address  National Institute of Unani Medicine Kottigepalya Magadi Main Road Bangalore KARNATAKA 560091 India

Bangalore
KARNATAKA
560091
India 
Phone  9341072974  
Fax    
Email  drmaquamri@gmail.com  
 
Details of Contact Person
Public Query  
Name  Prof Mohd Aleemuddin Quamri  
Designation  HoD -Dept. of Amraze Jild wa Tazeeniyat 
Affiliation  national institute of unani medicine 
Address  National Institute of Unani Medicine Kottigepalya Magadi Main Road Bangalore KARNATAKA 560091 India

Bangalore
KARNATAKA
560091
India 
Phone  9341072974  
Fax    
Email  drmaquamri@gmail.com  
 
Source of Monetary or Material Support  
nil 
 
Primary Sponsor  
Name  national institute of unani medicine 
Address  National Institute of Unani Medicine Kottigepalya Magadi Main Road Bangalore KARNATAKA 560091 India 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
nil  nil 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr khan shahina bano mohd vakeel  national institute of unani medicine  National Institute of Unani Medicine Kottigepalya Magadi Main Road Bangalore KARNATAKA 560091 India
Bangalore
KARNATAKA 		 9321769306

khanshahina101@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee for biomedical research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L088||Other specified local infections of the skin and subcutaneous tissue, (2) ICD-10 Condition: L088||Other specified local infections of the skin and subcutaneous tissue, (3) ICD-10 Condition: L088||Other specified local infections of the skin and subcutaneous tissue, (4) ICD-10 Condition: L089||Local infection of the skin and subcutaneous tissue, unspecified, (5) ICD-10 Condition: L088||Other specified local infections of the skin and subcutaneous tissue,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Joshanda musaffi (orally) + Clotrimazole 1% ointment(topically)   1. Orally: Joshanda Musaffi 15 gm in 50 ml OD (bf). 2. Topical: Apply clotrimazole 1 % lotion locally on the affected area twice daily. 
Intervention  Joshanda musaffi (orally) + Tila of ushaq, kundush, chob zard with sirka (topically)  1. Orally: Joshanda Musaffi 15 gm in 50 ml OD (bf). 2.Topical:Tila Take equal amount of kundush and ushaq and chob zard powder (1:1:1) mixed together in the sirka properly then apply locally on affected area twice daily. 
 
Inclusion Criteria  
Age From  18.00 Day(s)
Age To  65.00 Day(s)
Gender  Both 
Details  1 all gender
2 age between 18 to 65
3 known case of tinea incognito with chronicity equal or more then 6 month
4 clinically diagnose and mycologically confirm cases with treatment history of steroid
5 subject with diabetes mellitus with hba1c equal or more then 8 percent
6 subject who have agree to sign innform consent form 
 
ExclusionCriteria 
Details  1 Subjects with other skin diseases like psoriasis and eczema etc.
2 Subjects with history of hypertension, hypothyroidism, Tuberculosis, malignancy, on
immunosuppressants, contraceptives and uncontrolled diabetes mellitus, dyslipidemia, hepato
renal dysfunctions.
3 Subjects with history of treatment with antifungals, topical or systemic corticosteroids therapy
in the past 4 weeks.
4 Pregnant and lactating women. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1)Itching (5D Itch Scale)
2)Total Symptom Severity Score (TSSS)
3)Clinical Assessment Severity Scale (CASS)
4)KOH (Pre and Post) 		 7th Day, 14th Day, 21st Day, 28th Day. 
 
Secondary Outcome  
Outcome  TimePoints 
Decrease in Dermatology Life Quality Index (DLQI)
 		 Baseline 0, 28th day 
 
Target Sample Size   Total Sample Size="42"
Sample Size from India="42" 
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   Phase 2 
Date of First Enrollment (India)   05/01/2026 
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="6"
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  

This randomized, single-blind controlled clinical trial aims to evaluate the efficacy of Joshanda Mussaffi given orally along with the local application of Tila (Unani formulation) in comparison with topical Clotrimazole 1% lotion for the management of Tinea Incognito. Tinea Incognito is a dermatophytic infection modified by prior inappropriate corticosteroid use, often presenting with atypical features and delayed diagnosis.

A total of eligible patients fulfilling the inclusion and exclusion criteria will be randomly allocated into two groups. Group A will receive Joshanda Mussaffi orally with local application of Tila, while Group B will receive standard therapy with topical Clotrimazole 1% lotion. Sample size no 42.The treatment duration, follow-up schedule, and outcome assessment will be uniform for both groups.

The primary outcome will be the reduction in clinical severity based on signs and symptoms scoring. Secondary outcomes include improvement in pruritus, lesion size reduction, and mycological clearance confirmed by KOH microscopy. Safety assessment and adverse event monitoring will also be conducted throughout the study.

The study aims to scientifically validate the effectiveness and safety of traditional Unani treatment compared to standard antifungal therapy for Tinea Incognito.

 
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