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CTRI Number  CTRI/2023/11/059444 [Registered on: 02/11/2023] Trial Registered Prospectively
Last Modified On: 31/10/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Unani
Preventive
Screening
Behavioral
Other (Specify) [Therapeutic efficacy]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Evaluating efficacy and safety of Unani Formulation in Tinea Corporis and Tinea Cruris 
Scientific Title of Study   A Randomized, Parallel Group, Open Label, Active Controlled Clinical Study to Evaluate the Efficacy and Safety of a Unani Formulation ̶ Qurá¹£-i Sa‘fa (T) in the management of QÅ«bā (Tinea Corporis and Tinea Cruris). 
Trial Acronym  N/A 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sultan Ul Haque 
Designation  PG Scholar 
Affiliation  National Research Institute Of Unani Medicine For Skin Disorders 
Address  Department Of Moalajat, National Research Institute Of Unani Medicine For Skin Disorders, A.G. Colony Rd., Opposite ESI Hospital, Errgadda, Hyderabad-500038.

Hyderabad
TELANGANA
500038
India 
Phone  9219188867  
Fax    
Email  sultanu85@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Qamar Uddin 
Designation  Professor 
Affiliation  National Research Institute Of Unani Medicine For Skin Disorders 
Address  Department Of Moalajat, National Research Institute Of Unani Medicine For Skin Disorders, A.G. Colony Rd., Opposite ESI Hospital, Errgadda, Hyderabad-500038.

Hyderabad
TELANGANA
500038
India 
Phone  8700027178  
Fax    
Email  ccrumhqrsnd58@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sultan Ul Haque 
Designation  PG Scholar 
Affiliation  National Research Institute Of Unani Medicine For Skin Disorders 
Address  Department Of Moalajat, National Research Institute Of Unani Medicine For Skin Disorders, A.G. Colony Rd., Opposite ESI Hospital, Errgadda, Hyderabad-500038.

Hyderabad
TELANGANA
500038
India 
Phone  9219188867  
Fax    
Email  sultanu85@gmail.com  
 
Source of Monetary or Material Support  
National Research Institute Of Unani Medicine For Skin Disorders 
 
Primary Sponsor  
Name  National Research Institute Of Unani Medicine For Skin Disorders 
Address  A.G. Colony Road, Opposite ESI Hospital, Erragadda, Hyderabad-500038 
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 Sultan Ul Haque  National Reasearch Institute Of Unani Medicine For skin Disorders  OPD & IPD of Department Of Moalajat, National Research Institute Of Unani Medicine For Skin Disorders. A.G. Colony Road, Opposite ESI Hospital, Erragadda, Hyderabad-500038
Hyderabad
TELANGANA 		 9219188867

sultanu85@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical Committee, NRIUMSD, Hyderabad  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,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Clotrimazole  • Dosage Form: 1% cream • Route of Administration: Topical Application • Dosage: Cream will be applied topically on the affected site twice daily for 6 weeks 
Intervention  Qurá¹£-i Sa‘fa  • Qurá¹£-i Sa‘fa: Participants will be advised to crush the tablet in Ä€b-i KāsnÄ« (Cichorium intybus Linn.Juice) to make liniment and apply topically on the affected site twice daily for 6 weeks. • Dosage Form: Qurá¹£ (tablet) to be used in the form of liniment (making in Ä€b-i KāsnÄ«- Cichorium intybus Juice) for topical application • Route of Administration: Topical Application • Dose: to be applied topically as per requirement. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1. Participants of QÅ«bā (Tinea corporis and Tinea cruris) having circumscribed lesions with any of the following signs and symptoms on body and limbs:
A)Presence of pruritus and burning
B)Presence of scales
C)Presence of central clearing
D)Erythematous papules
2. Participants with Positive KOH (10%) Smear Microscopy of Skin Scrapping from the active lesion for Dermatophytic hyphae. 
 
ExclusionCriteria 
Details  The following patients will be excluded:
1) Age below 18 years and above 50 years
2) Patients with other form of tinea infection like tinea pedis, tinea manuum, tinea unguium, tinea faciei, etc.
3) Patient with other concomitant diseases like psoriasis & eczema
4) Patients who have received any topical antifungal therapy within last 2 weeks or oral antifungal therapy in the previous 4 weeks
5) Patients with known active pulmonary/ cardiovascular/ liver/ renal or neurological diseases
6) Known cases of Diabetes Mellitus or other immunocompromised disorders (HIV/ AIDS, etc.)/ Malignancies
7) Patients with long-term history of steroid, cytotoxic and immunosuppressive therapy
8) History of hypersensitivity to either clotrimazole or Qurṣ-i Sa‘fa
9) Pregnant or lactating women, and women desiring pregnancy
10) Participants not willing to give consent and to attend treatment schedule regularly. 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. Total Signs & Symptoms Score (TSSS) (Clinical Cure)
2. Conversion to Negative Mycology (Mycological Cure)
3. DLQI (Dermatology Life Quality Index) 		 42 Days 
 
Secondary Outcome  
Outcome  TimePoints 
Systemic Safety assessment  42 Days 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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/ Phase 3 
Date of First Enrollment (India)   10/11/2023 
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   According to observations worldwide, dermatophytosis is the most common of the superficial fungal infections. It is more common in tropical region and may present in epidemic proportions in areas with high rates of humidity. Skin mycoses are currently one of the most common types of infections, affecting more than 20–25% of the global population due to a significant increase in the incidence of superficial mycotic infections over the past several decades. In India, it is more prevalent in Southern states as the climate of these areas are more hot and humid which is favorable for the dermatophytes.There are many unani formulations which are mentioned and being used from several decades. Although those formulations were used by many ancient Unani physicians and still are being used but some of them are not yet scientifically evaluated on modern parameters. Keeping this in view, the present study was designed to evaluate the safety and efficacy of the polyherbal formulation in case of QÅ«bā. Which is taken from Al-Qarabadin. 
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