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CTRI Number  CTRI/2017/12/010995 [Registered on: 27/12/2017] Trial Registered Prospectively
Last Modified On: 23/08/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Unani 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Study of Marham Kharish Jadeed (Unani Drug) in Ringworm  
Scientific Title of Study   A Clinical Study to Evaluate the Efficacy and Safety of Marham Kharish Jadeed in the Management of Quba (Tinea Corporis)  
Trial Acronym  TMKJ 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Aaliya 
Designation  PG Scholar 
Affiliation  Central Research Institute of Unani Medicine, Hyderabad 
Address  Deptt. of Moalajat, Central Research Institute of Unani Medicine, Opp. ESI Hospital, AG Colony Road, Erragadda, Hyderabad, Telangana, 500038

Hyderabad
ANDHRA PRADESH
500038
India 
Phone  9582856055  
Fax    
Email  aaliya.ansari974@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Prof Qamar Uddin 
Designation  Professor & HOD Moalajat 
Affiliation  Central Research Institute of Unani Medicine, Hyderabad 
Address  Deptt. of Moalajat, Central Research Institute of Unani Medicine, Opp. ESI Hospital, AG Colony Road, Erragadda, Hyderabad, Telangana, 500038

Hyderabad
ANDHRA PRADESH
500038
India 
Phone  8700027178  
Fax    
Email  ccrumhqrsnd58@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Arzeena Jabeen 
Designation  Lecturer 
Affiliation  Central Research Institute of Unani Medicine, Hyderabad 
Address  Deptt. of Moalajat, Central Research Institute of Unani Medicine, Opp. ESI Hospital, AG Colony Road, Erragadda, Hyderabad, Telangana, 500038

Hyderabad
ANDHRA PRADESH
500038
India 
Phone  9032519286  
Fax    
Email  aarzu763@gmail.com  
 
Source of Monetary or Material Support  
Central Council for Research in Unani Medicine, MInistry of AYUSH 
 
Primary Sponsor  
Name  Central Research Institute of Unani Medicine 
Address  Opp. ESI Hospital, AG Colony Road, Erragadda, Hyderabad, Telangana, 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 
AALIYA  Central Research Institute of Unani Medicine  GOPD No. 3 New OPD block, CRIUM, Opp. ESI Hospital, AG Colony Road, Erragadda, Hyderabad, Telangana, 500038
Hyderabad
ANDHRA PRADESH 
9582856055

aaliya.ansari974@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee CRIUM Hyderabad  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  QUBA (TINEA CORPORIS),  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Marham Kharish Jadeed  Marham will be applied locally on the affected parts twice daily. Duration: 28 days 
Comparator Agent  Terbinafine Hydrochloride cream 1%   Cream will be applied locally on the affected parts twice daily. Duration 28 days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Patients having Quba (Tinea corporis) with the following signs and symptom:
a.Itching
b.Erythema
c.Scaling of lesion
d.Central clearing with peripheral raised margins
2.Patients with a mycological diagnosis of Tinea Corporis confirmed by microscopic KOH wet mount 
 
ExclusionCriteria 
Details  1.All other clinical types of tinea infections
2.Patients with secondary bacterial infections/ Diabetes Mellitus
3.Pregnant and lactating women
4.Significant Pulmonary/Cardiovascular/Hepato-renal Dysfunction
5.Known cases of Immunocompromised states (HIV/ AIDS, etc.)
6.History of hypersensitivity to Terbinafine and Marham Kharish Jadeed
7.Patients using the following medications:
8.Topical antifungal agent/ topical corticosteroids in treatment area within 30 days of baseline visit
9.Systemic anti-fungals within 8 weeks of baseline visit (8 months for oral Terbinafine)
10.Systemic corticosteroids within 30 days of baseline visit
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1.To evaluate the efficacy of Marham Kharish Jadeed in the management of Quba (Tinea corporis)
2.To evaluate the safety of Marham Kharish Jadeed in the management of Quba (Tinea corporis) 
at baseline 2 3 & 4 week 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the improvement in quality of life in patients with Quba by TSSS KOH mount, IGA  at baseline 2 3 & 4 week 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   01/02/2018 
Date of Study Completion (India) Date Missing 
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   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary
Modification(s)  

Dermatophytic infections are a common clinical problem encountered in more than 50% of participants attending the dermatology departments.  According to WHO, about 25% of the world population is affected by dermatophytic infections. It is also estimated that 30 to 70% of adults are asymptomatic carriers of these pathogens, and that the incidence of this disease increases with age. The estimated life-time risk of acquiring dermatophytosis is between 10 to 20 percent. It is caused by Trichophyton, Microsporum, and Epidermophyton which may infect hair, scalp, arms, legs, trunk, groin, and nails.

      Among various subtypes of dermatophytoses, tinea corporis is a very common skin infection which refers to the dermatophytic infection involving trunk, legs, arms, and neck excluding feet, hands, and groin. The trunk is the most common site. The lesions are itchy, erythematous and scaly patches with well-defined borders. The borders are more prominent and often have papules and pustules. There may be central clearing so that annular or circinate patterns are formed. As the lesion progresses, the border advances centrifugally. The major risk factors of tinea corporis are overcrowding, poor hygiene, and low standards of living along with high humidity. Hence, tinea corporis is more prevalent in tropical and subtropical areas of the world, especially in India.

      In conventional medicine, certain antifungal drugs such as terbinafine, fluconazole, itraconazole, ketoconazole, griseofulvin, and cotrimazole are used in the management of dermatophytosis with various degrees of resistance and certain side effects such as erythema, itching, dryness, irritation and urticaria etc. Hence, there is a dire need to search for a safe and effective drug for the management of tinea corporis.

      In Unani System of medicine, Quba is characterized by rough and hyperpigmented patch associated with intense itching but devoid of pain. It has been treated by eminent Unani physicians since antiquity. There are so many topical formulations being used in Quba, i.e., Marham Kharish Jadeed, Marham-i Quba, Habb-i Quba  etc. Moreover, drugs possessing Mubarrid, Dafi’-i Ufunat, Mujaffif, Muhallil, and Musaffi-i Dam actions are used in management of Quba such as Gandhak, Sang-i JarahatBarg-i-Hina, Kamila, Arad-i Baqla Arad-i Nakhud, etc.

      Among these compound formulations, Marham Kharish Jadeed has been extensively used for the management of tinea corporis due to presence of above mentioned properties, but till date its efficacy has not been evaluated on scientific parameters. Hence, in order to validate its efficacy in the management of Quba (Tinea corporis), the present clinical trial entitled â€œA Clinical Study to Evaluate the Efficacy and Safety of Marham Kharish Jadeed in the Management of Quba (Tinea Corporis) has been designed.

 
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