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CTRI Number  CTRI/2024/11/077215 [Registered on: 21/11/2024] Trial Registered Prospectively
Last Modified On: 19/11/2024
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   Evaluating the safety and efficacy of unani formulation in treating Nār FārsÄ«(Eczema) 
Scientific Title of Study   A Randomized, Parallel Group, Open Label, Active Controlled Clinical Study to evaluate the Safety and Efficacy of SafÅ«f Muá¹£affi Khāṣ plus topical Unani Formulation in the Management of Nār FārsÄ« (Eczema) 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Asra Sultana 
Designation  P G 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 Road, Opposite ESI Hospital, Erragadda, Hyderabad 500038.

Hyderabad
TELANGANA
500038
India 
Phone  7785074500  
Fax    
Email  asra123ansari@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr K Mohammed Nasar 
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 Road, Opposite ESI Hospital, Erragadda, Hyderabad 500038

Hyderabad
TELANGANA
500038
India 
Phone  8328446962  
Fax    
Email  drnasar.nriumsd@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr K Mohammed Nasar 
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 Road, Opposite ESI Hospital, Erragadda, Hyderabad 500038

Hyderabad
TELANGANA
500038
India 
Phone  8328446962  
Fax    
Email  drnasar.nriumsd@gmail.com  
 
Source of Monetary or Material Support  
National Research Institute of Unani Medicine for Skin Disorders, A G Colony Road,Opposite ESI Hospial, Erragadda,Hyderabad,Telangana 500038.India  
 
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 Asra Sultana  National Research 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 		 7785074500

asra123ansari@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, NRIUMSD, Hyderabad  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L309||Dermatitis, unspecified, (2) ICD-10 Condition: L309||Dermatitis, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  1.Safuf-e-Musaffi-e-Khas (oral) 2.Marham (Topical)   1.Safuf-e-Musaffi-e-Khas Dosage form:powder Dose:5gm OD Mode of administration:oral Composition of Safuf-e-Musaffi-e-Khas: Amla (Khushk Emblica officianalis) Bach (Acorus calamus L.) Post e Baheda(Terminalia belerica) Post e darakhte neem (Azadirachta indica ) Post haleela zard (Terminalia chebula retz)Dar e hald (Berberis aristata) Kutki (Picrorhiza kurroa) Gelu khushk (Tinospora cordifolia) Majeeth (Rubia cordifolia L.) 2.Marham (ointment) Dosage form:Semisolid paste Dose:Q.S Mode of administration:Topical Composition of Marham: Kuchla( Strychnuos nux vomica L.) Phitakri (Potassi alumimiun sulphate) Ghee (Clarified butter) 
Comparator Agent  1.Tab Levocitrizine(Oral) 2.Clobetasol propionate 0.05% cream(Topical)  1.Tab Levocitrizine Dose:5mg Mode of administration:Oral 2.Clobetasol propionate 0.05% cream Dose:Q.S Mode of administration:Topical  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Participants of any gender between 18 to 65 years
2.Participants having the following any signs and symptoms of disease likeItching, Erythema, Visible flexural eczema, Excoriation,
Hyperpigmentation, Burning sensation,Lichenification, Crusting, Dry skin
3.Chronicity of more than 6 months and less than 2 years 
 
ExclusionCriteria 
Details  1.Known cases of significant
Pulmonary/Cardiovascular/Hepato-renal
Dysfunction, Malignancy, HIV infection, AIDS, etc.
2.Any other clinical condition that in the opinion of the investigator wouldcompromise the patient’s safety or successful participation in the trial.
3.Pregnancy and Lactation
4. Known allergy, sensitivity or intolerance to the study drug or any of its
ingredients
5. Participants who are using steroids or other drugs
6.Participants with active alcohol intake and/or drug abuse 
 
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 
Reduction in EASI Score from baseline  56 DAYS 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in CDSQ Score from baseline  56 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)   24/01/2025 
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   Eczema is a particular pattern of inflammatory response in the skin, of which spongiosis (epidermal edema) is the hallmark  it may be included by both internal factors acting singly or in combination. According to unani system of medicine, it is an Afunati (infectious) skin disorder with eruptions having severe burning sensation and itching.It is caused by safra (yellow bile) mixed with small quantity of sawda (black bile) or haadd safrii (Acrid yellow bile)  mixed with Dam(Sanuine) and usually occurs during epidemics.Keeping all this facts in consideration the present study has been planned to evaluate the safety and efficacy of Safuf -e -Musafi-e-khas for oral  and a topical unani formulation  Marham (Ointment) compared to levocitrizine orally and clobetasol propionate 0.05% topically in the management of Naar Faarsi (Eczema) 
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