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CTRI Number  CTRI/2017/12/010957 [Registered on: 21/12/2017] Trial Registered Prospectively
Last Modified On: 19/12/2017
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Unani 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Treatment of ithy, red, dry and cracked skin condition (Eczema) by of Unani drug 
Scientific Title of Study   A Clinical Study to Evaluate the Efficacy and Safety of Marham-e-Safeda Kafoori in the Management of Nar Farsi (Eczema) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Khurshid Alam 
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

Hyderabad
ANDHRA PRADESH
500038
India 
Phone  8791430329  
Fax    
Email  khursheed6459@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Mohammad Nawab 
Designation  Reader 
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

Hyderabad
ANDHRA PRADESH
500038
India 
Phone  8100992044  
Fax    
Email  ccrumnawab@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Prof Qamar Uddin 
Designation  Professor and 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

Hyderabad
ANDHRA PRADESH
500038
India 
Phone  8700027178  
Fax    
Email  ccrumhqrsnd58@gmail.com  
 
Source of Monetary or Material Support  
Central Research Institute of Unani Medicine, Opp. ESI Hospital, AG Colony Road, Erragadda, Hyderabad, Telangana, 500038 
 
Primary Sponsor  
Name  Central Research Institute of Unani Medicine 
Address  Central Research Institute of Unani Medicine, 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 
Khurshid Alam  Central Research Institute of Unani Medicine  Deptt. of Moalajat, OPD no. 1, Ground floor, New OPD block, Central Research Institute of Unani Medicine, Opp. ESI Hospital, AG Colony Road, Erragadda, 500038
Hyderabad
ANDHRA PRADESH 
8791430329

khursheed6459@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  Nar Farsi (Eczema),  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Control Group : Clobetasol propionate  Dosage form: Ointment Route of Adminstration: Local  
Intervention  Study Drug: Marham-e-Safeda Kafoori   Topical application on affected parts.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Patients of any sex in the age group of 18 to 65 years
2. Patients having the following symptoms:
3. Erythema
4. Scaling
5. Lichenification
6. Excoriation
Hyperpigmentation
Burnig Sensation
Itching
 
 
ExclusionCriteria 
Details  1. Patients aged below 18 years and above 65 years
2. Patients on concomitant therapy
3. Co-morbid patient
4. Patients suffering from: Diabetes mellitus, Hypertension
5. Pregnant and Lactating women
 
 
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 
To evaluate the efficacy of Marham-e-Safeda Kafoori in the management of Nar Farsi Talluqi (Contact Eczema)
To evaluate safety of Marham-e-Safeda Kafoori in the management of Nar Farsi Talluqi (Contact Eczema) 
at baseline, 7th, 14th, 21st, 28th, 35th and 42th day
 
 
Secondary Outcome  
Outcome  TimePoints 
Assessment of safety of the study drug  at baseline, 7th, 14th, 21st, 28th, 35th and 42th day
 
 
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)   01/02/2018 
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   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Nar Farsi (Eczema) is a group of diseases that results in inflammation of the skin and characterized by itchiness, red skin, and a rash. There are various forms of Nar Farsi (Eczema). Nar Farsi T’alluqi (Contact Eczema) is an inflammatory skin process caused by an exogenous agent or agents that directly or indirectly injure the skin. Contact eczema results from a complex interaction between external substances or contactant and skin. It accounts for 4% to 7% of all patients presenting to the dermatology clinics. It is classified as irritant or allergic. In irritant contact dermatitis (ICD), this injury is caused by an inherent characteristic of a compound –for example, a concentrated acid or base. Agents that cause Allergic contact dermatitis (ACD) induce an antigen-specific immune response. The clinical lesion of contact Eczema may be acute (wet and edematous) or chronic   (dry, thickened, and scaly), depending on the persistence of the insult.

    Irritant contact dermatitis (ICD) is defined as a non immunological inflammatory reaction of the skin to external agents which cause direct toxic injury. It is caused by substances like alkalis, acids, organic solvents oxidants and reducing agent. Acute ICD is painful, associated with burning, stinging or itching. Mild irritants cause erythema, dryness and fissuring while strong irritants often cause oedema, blistering and ulceration.

     Allergic contact dermatitis (ACD) occurs due to a delayed type 4 cell-mediated immunity. A minimum of 8 days to 10 days are needed after sensitization for clinical allergy to manifest. Once sensitisation to an allergen occurs, it tends to persist throughout life. However, the degree of sensitivity wanes with time unless repeated exposures occurs.

     Allergic contact dermatitis may clinically present acute after allergen exposure and initial sensitization or after elicitation in a previously sensitized individual. Erythema, oedema, papules, vesicles and oozing are the cardinal signs of acute onset of eczematous ACD. In India the common sensitisers are plants specially parthenium hysterophorus, nickel, chromium and paraphenylene diamine. Parthenium allergy manifests as air born contact dermatitis affecting the face, including the eyelids neck and flexures.

     An enormous number of substances are capable of causing allergic contect dermatitis. Nickel dermatitis is one of the commonest examples-some 5 percent of women in the UK are said to be nickel sensitive. Affected individuals cannot wear stainless-steel jewellery because of the nickel in the steel and develop a rash beneath steel studs, clips and buckles. Patients who are nickel sensitive may also react to dichromate and other chromate salts.

     The pathogenesis of Contact Eczema is complex and still incompletely understood. In management of Contact Eczema, topical steroids, immunosuppressant and bland emollients are in use but they only suppress the symptoms and relapse is always there. The specific measures include emollients as well as steroids. The topical and systemic steroid can cause several side effects.    

Due to the high prevalence and non availability of safe and effective treatment, present study is being designed to Evaluate the Efficacy and Safety of Marham-e-Safeda Kafoori in the Management of Nar Farsi T’alluqi (Contact Eczema).

 
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