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CTRI Number  CTRI/2024/11/076373 [Registered on: 08/11/2024] Trial Registered Prospectively
Last Modified On: 25/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Unani 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Research on effect of Unani Medicine in Eczema 
Scientific Title of Study   A Comparative Clinical Study on the Efficacy of Arq-e-Shahetra orally and Mazo with Sirka vs Mirch e Siyah wa Safed with Cows Ghee Locally in Nar-e-Farsi (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  Dr Syed Shuaib Pasha  
Designation  PG Scholar 
Affiliation  Government Unani Medical College and Hospital 
Address  Department of Amraz Jild Wa Tazeeniyat, Room no.8, Government Unani Medical College and Hospital Dr. Siddaiah Puranik Road, Basaveshwaranagar, Bangalore 560079

Bangalore
KARNATAKA
560079
India 
Phone  8105931313  
Fax    
Email  drsyedshuaib@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Mohammed Asif Siddiqui  
Designation  Assistant professor  
Affiliation  Government Unani Medical College and Hospital  
Address  Department of Amraz Jild Wa Tazeeniyat, Room no.8, Government Unani Medical College and Hospital Dr. Siddaiah Puranik Road, Basaveshwaranagar, Bangalore 560079

Bangalore
KARNATAKA
560079
India 
Phone  9986812499  
Fax    
Email  drasif.i.siddiqui@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Mohammed Asif Siddiqui  
Designation  Assistant professor  
Affiliation  Government Unani Medical College and Hospital  
Address  Department of Amraz Jild Wa Tazeeniyat, Room no.8, Government Unani Medical College and Hospital Dr. Siddaiah Puranik Road, Basaveshwaranagar, Bangalore 560079

Bangalore
KARNATAKA
560079
India 
Phone  9986812499  
Fax    
Email  drasif.i.siddiqui@gmail.com  
 
Source of Monetary or Material Support  
Government Unani Medical College & Hospital Bangalore-560079, Karnataka, India 
 
Primary Sponsor  
Name  Government Unani Medical College & Hospital Bangalore-560079 
Address  Government Unani Medical College and Hospital Dr Siddaiah Puranik Road, Basaveshwaranagar Bangalore-560079  
Type of Sponsor  Government medical college 
 
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 Syed Shuaib Pasha  Government Unani Medical College and Hospital  Department of Amraz Jild Wa Tazeeniyat, Room no.8, Dr. Siddaiah Puranik Road, Basaveshwaranagar, Bangalore 560079
Bangalore
KARNATAKA 
8105931313

drsyedshuaib@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (IEC) for Biomedical research, Government Unani Medical College and Hospital, Bangalore.   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L309||Dermatitis, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Shahetra (Fumariya Parviflora Lam) orally and Mazo (Quercus Infectoria Oliv) with sirka locally.  Arq e Shahetra will be procured from Market.30 ml of Arq will be given before breakfast and dinner daily orally for 45 days. Mazo will be powdered and mixed with Sirka and zimaad will be prepared and applied on lesions.  
Comparator Agent  Shahetra (Fumariya Parviflora Lam) orally and Safed Mirch (Piper Nigrum Linn), Siyah Mirch (Piper Nigrum Linn)and Cow Ghee Clarified Butter locally.   Arq e Shahetra will be procured from Market.30 ml of Arq will be given before breakfast and dinner daily orally for 45 days. Safed and Siyah Mirch will be powdered and mixed with Cow Ghee and Zimaad will be prepared and applied on lesions.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients of age group between age 18 - 60 years
Patients of both genders
Clinically diagnosed patients of eczema as per Hanifin and Rajika criteria
Eczema of mild to moderate as per EASI score (≤29%)
History of Eczema less than 5 Years
 
 
ExclusionCriteria 
Details  Patients with other skin diseases like psoriasis, lichen planus and active acute infections
Patients with diabetes , sys Htn , malignancy , autoimmune and other systemic diseases
Pregnant and lactating women
Patients not willing to attend treatment schedule regularly
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Other 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
• Decrease in Eczema Area and Severity Index (EASI) score.
• Change in photographs of the lesion
 
0TH Day,15th Day,30th Day 45th Day of study. post
follow up on 60th day.
 
 
Secondary Outcome  
Outcome  TimePoints 
•Decrease in Patient Oriented Eczema Measures (POEM) Questionnaire  0TH Day,15th Day,30th Day 45th Day of study. post
follow up on 60th day.
 
 
Target Sample Size   Total Sample Size="36"
Sample Size from India="36" 
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)   10/11/2024 
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 (Nar-e-Farsi) is a inflammatory skin condition, characterized by dry skin with itchy patches which typically flactuates between periods of remission and flares. According to Ibn Abi Sadique Nar-e-Farsi is named because Naar means Aag as a patient feel more irritation and burning sensation in those lesions, Farsi means it was more common among the people of Mulk Faras( Persia) or referred to the physician who treated Nar-e-Farsi first also was a resident of Mulk Faras(Persia). M H Qamri described Nar-e-Farsi as a type of itch related to very severe non bearable burning , it occurs in some organs with vesiculation and the vesicles are filled with Raqeeq Rutubat (Thin fluid), which is due to increase of Hiddat in Khilt e Dam.Akbar Arzani also described Nar-e-Farsi as a skin disease associated with vesicle formation , itching and burning.Nar-e-Farsi is a type of disease which occurs due to alteration in humors and specially Lateef Safravi Mawaad (light yellow bile) which are eliminated towards the skin and appear in the form of vesicles with severe itching and burning . Along with safra some ghaleez mawaad is also accumulated which is responsible for itching, burning and chronicity of disease and Lateef Mawad  is responsible for burning superficially .Eczema are classified into 3 groups based on etiology.

Endogenous Eczema : Constitutional factors predispose the patient to develop an eczema. Eg : Nummular dermatitis.

Exogenous Eczema : External stimuli triggers development of Eczema. Eg : Irritant dermatitis.

Combined Eczema : when a combination of constitutional factors and extrinsic triggers  are responsible for the development of eczema. Eg : Atopic Dermatitis.

Clinical features of eczema are divided into 3 stages .

Acute eczema is characterized by intense pruritus ,erythema, oedema , papules , vesicles , oozing ,crusting and even blister formation. In subacute Eczema there is diffused erythema, oedema, and scaling in this stage oedema, vesiculation and oozing components come down and lesion starts scaling.  Chronic Eczema presents with severe pruritus, erythema, oedema, hyperkeratosis and lichenification.The signs and symptoms of Eczema are assessed on the basis of eczema area and severity index EASI score  and patient oriented eczema measure POEM questionnair. This is more feasible in obtaining a quick and simple understanding of severity of disease and response to medication. A study recommends using EASI score with POEM Questionnaire to assess objective and subjective disease severity measurement. 

In Unani system of medicine ,management of Nar-e-Farsi depends on various factors like environment, lifestyle, diet and family history of patient. First and  foremost predisposing and aggrevating factors should be eliminated, suitable changes in lifestyle and diet to be done and istefragh by means of Fasd and correction of  the Sue Mizaj is recommended. Drugs possessing properties like Musaffi e Dam(blood purifier),Mujaffif(desiccative), Musakkin(soothing), Mubarrid(coolent), Muhallil(resolvant) are indicated for the treatment of Nar-e Farsi like Ushba , Shahetra , Sandal Safaid ,Chiraita ,Mundi ,Chobchini, Bisfaij , Kafoor , Raal , Kat Safaid , Gil-e-Armani , Mazo . Based on above properties a Unani formulation of Arq-e-Shahetra  orally  and Zimaad of Mazo with Sirka and Mirch e Siyah wa Safed with Cows Ghee locally are selected to evaluate there efficacy in Nar-e- Farsi.

 
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