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CTRI Number  CTRI/2023/03/051134 [Registered on: 28/03/2023] Trial Registered Prospectively
Last Modified On: 27/03/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Unani 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A Clinical Study to compare the Efficacy and Safety of Marham-e-Dād with Terbinafine in the Management of QÅ«bā (Ringworm) 
Scientific Title of Study   A Randomized, Parallel Group, Open Label, Active Controlled Clinical Study to compare the Efficacy and Safety of Marham-e-Dād with Terbinafine in the Management of QÅ«bā (Ringworm) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Anam Farah Sayyed Nisar 
Designation  M.D Scholar , Moalajat 
Affiliation  National Research Institute of Unani Medicine for Skin Disorders 
Address  National Research Institute of Unani Medicine for Skin Disorders,A.G.’s Colony Road, Opp. ESI Hospital, Erragadda,

Hyderabad
TELANGANA
500038
India 
Phone  8055669281  
Fax    
Email  anamsyd1996@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Qamar Uddin 
Designation  Proffesor & HOD, Moalajat 
Affiliation  National Research Institute of Unani Medicine for Skin Disorders 
Address  National Research Institute of Unani Medicine for Skin Disorders,A.G.’s Colony Road, Opp. ESI Hospital, Erragadda,

Hyderabad
TELANGANA
500038
India 
Phone  8700027178  
Fax    
Email  ccrumhqrsnd58@gmail.com  
 
Details of Contact Person
Public Query  
Name  Anam Farah Sayyed Nisar 
Designation  M.D Scholar, Moalajat  
Affiliation  National Research Institute of Unani Medicine for Skin Disorders 
Address  National Research Institute of Unani Medicine for Skin Disorders,A.G.’s Colony Road, Opp. ESI Hospital, Erragadda,

Hyderabad
TELANGANA
500038
India 
Phone  8055669281  
Fax    
Email  anamsyd1996@gmail.com  
 
Source of Monetary or Material Support  
National Research Institute of Unani Medicine for Skin Disorders, Hyderabad 
 
Primary Sponsor  
Name  National Research Institute of Unani Medicine for Skin Disorders 
Address  A.G.’s Colony Road, Opp. ESI Hospital, Erragadda, Hyderabad-500038  
Type of Sponsor  Research institution 
 
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 
Anam Farah Sayyed Nisar  National Research Institute of Unani Medicine for Skin Disorders   OPD Department of Moalajat, National Research Institute of Unani Medicine for Skin Disorders, A.G. Colony Road, Opp. ESI Hospital, Erragadda 500038
Hyderabad
TELANGANA 		 8055669281

anamsyd1996@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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: B354||Tinea corporis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Marham-e- Dād   sufficient quantity of Cream will be mix with vinegar and apply locally on affected part twice daily for 42 days 
Comparator Agent  Terbinafine cream 1%  sufficient quantity of Cream will be applied locally on the affected part twice daily for 42 days 
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  a) 1. Circumscribed lesions having any of the following signs and
symptoms on body:
.Presence of pruritus and burning
.Presence of scales_
.Presence of central clearing
.Erythematous papules
b) Participants with positive mycology (KOH positive).
c)| Participants of either sex in age group of 19-60 years. 
 
ExclusionCriteria 
Details  a) Co-morbid conditions of the participants
b) Pregnant or Lactating Women
c) Significant Pulmonary/Cardiovascular/Hepato-renal Dysfunction
d) Known cases of Immuno-compromised states (HIV/ AIDS, etc.)/Malignancies
Participants not willing to attend treatment schedule regularly
e) History of hypersensitivity to Itraconazole and Terbinafine.
F) Patient having diabetic.
g) Participants using the following medications:
. Systemic antifungal within 15 days of baseline visit.
. Systemic corticosteroids within 15 days of baseline visit. 
 
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 
Total Signs and Symptoms Score(TSSS)
 		 42 days
 
 
Secondary Outcome  
Outcome  TimePoints 
1.Conversion to Negative Mycology
2.Systemic Safety Assesssment 		 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 
Date of First Enrollment (India)   05/04/2023 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None yet  
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

-The prevalence rate of QÅ«bā(Ringworm) has been found to be 20-25% worldwide.

-It is more prevalent in tropical and subtropical countries like India where the heat and humidity is high throughout the year. –

-QÅ«bā (Ringworm) also has many ill impact on the patient’s quality of life.

-In conventional medicine, some antifungal drugs are used in the treatment of Ringworm, which are becoming resistant to the organism and also have certain adverse effects with antifungal drugs are erythema, itching, dryness, irritation  nausea, hepatotoxity, abdominal pain, headache, rashes, hypokalemia and oligozoospermia etc.

-Hence, there is need to search more effective and safe drugs in management of QÅ«bā (Ringworm).keeping this in view, a unani formulation Marham-e- Dād has been selected to evaluate its efficacy and safety in the management of QÅ«bā (ringworm)

  

 
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