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CTRI Number  CTRI/2020/03/024360 [Registered on: 30/03/2020] Trial Registered Prospectively
Last Modified On: 23/03/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Unani 
Study Design  Single Arm Study 
Public Title of Study   Clinical study for the effectiveness of Unani drug in Ezema 
Scientific Title of Study   Therapeutic evaluation of Marham-e-Akbar in Nar-e-farsi -An Observational study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
BJP/LUMC/PG/IEC/04/2018-19/MOALIJAT/03  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shaikh Imran  
Designation  PG scholar  
Affiliation  Luqman Unani Medical College Hospital and Research Center 
Address  PG dept of Moalajat, Luqman Unani Medical College Hospital and Research Center, 12 Naubagh, Bijapur (Vijaypura)

Bijapur
KARNATAKA
586101
India 
Phone  9145544901  
Fax    
Email  imrandr1987@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Mohd Qudrathullah 
Designation  Professor 
Affiliation  Luqman Unani Medical College Hospital and Research Center 
Address  PG dept of Moalajat, Luqman Unani Medical College Hospital and Research Center, 12 Naubagh, Bijapur (Vijaypura)

Bijapur
KARNATAKA
586101
India 
Phone    
Fax    
Email  drqudrathullah@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Mohd Khalid 
Designation  Assistant Professor 
Affiliation  Luqman Unani Medical College Hospital and Research Center 
Address  PG dept of Moalajat, Luqman Unani Medical College Hospital and Research Center, 12 Naubagh, Bijapur (Vijaypura)

Bijapur
KARNATAKA
586101
India 
Phone  9916261251  
Fax    
Email  Khalidhameedkhan@gmail.com  
 
Source of Monetary or Material Support  
Luqman Unani Medical College Hospital and Research Center, 12, Naubagh, Bijapur (Vijaypura) 586101 
 
Primary Sponsor  
Name  Luqman Unani Medical College hospital  
Address  12, Naubagh, Bijapur (Vijaypura) 586101 
Type of Sponsor  Private 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 
Shaikh Imran  Moalajat OPD No. 1, Ground Floor, Luqman Unani Medical College Hospital and Research Center  12 Naubagh, Bijapur (Vijaypura) 586101
Bijapur
KARNATAKA 
9145544901

imrandr1987@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Luqman Unani Medical College Hospital & Research Center  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L209||Atopic dermatitis, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Marham Akbar  Safeda Kashgari 7 gm Sindur 7 gm Murdarsang 10 gm Phitkiri 7 gm Kath-tha 7 gm Olive oil 10 ml Dose: Quantity sufficient; twice daily for 40 days 
Comparator Agent  nil  nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1 Patients full-filling Hanifin and Rajka’s criteria
2 Patients with mild to moderate eczema
3 Patients of both gender,
4 Patients in age group of 18 to 65years
 
 
ExclusionCriteria 
Details  1 Patients who are allergic to any product as well as history or presence any type of malignancy including any skin cancer or suspicious lesions.
2 Any systemic illness
3 Pregnant and lactating mothers.

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
SCORAD -Dermatologic assessments by Severity Scoring of Atopic Dermatitis ( for severity and size of lesions )
 
Before and After Treatment
 
 
Secondary Outcome  
Outcome  TimePoints 
QOL assessments - Dermatologic Life Quality Index (DLQI)

 
Before and After Treatment 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   01/04/2020 
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   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

          Atopic dermatitis (AD) is a chronic and relapsing disease affecting an increasing number of patients.1 The prevalence of Atopic Eczema has risen substantially in many countries in recent decades, and this increase has been attributed mainly to changes in lifestyle, nutrition, and environmental factors 2. Since 1960s, the prevalence of AE has increased more than 3-fold. The reasons for the rising prevalence are as yet unclear. We suggest that the basis for this increase in prevalence, as well as the causes of AE, involve an in­teraction between genetic and environmental factors3.

         Eczema is described as Narfarsi in almost all classical books of Unani System of Medicine. Unani physicians have been treating this disease for thousands of years and they have mentioned various drugs (single as well as compound) for its treatment. However, these drugs have not been scientifically studied so far, for their described effects. Although, certain topical and systemic drugs of allopathic medicine provide effective treatment but recurrence rate has been reported too high with these drugs. Therefore, the present study entitled “Therapeutic Evaluation of the clinical efficacy of Marham-e-Akbar 4 in Nar-e-Farsi (Eczema)” is being designed.

         The terms ‘eczema” and ‘dermatitis’ are synonymous. They refer to distinctive reaction  patterns  in the skin , which can be either acute or chronic and are due to a number of causes.5     Majoosi (930-994) said that Nar Farsi occur sometime as single and sometimes with Small pox (Chechak) and the same treatment is applied for both.6 Akbar Arzani (1722 AD) also described Nar Farsi in his book Tibb  e Akbar as a skin disease associated with vesicle formation, itching and burning.7  Eczema or dermatitis is a group of inflammatory  skin diseases provoked by a wide variety of stimuli including direct injury from toxic chemicals, mechanical  trauma  and immunological reactions. The word eczema is derived from the Greek word  ‘eczein ’meaning ‘to boil over ’ or  ‘to effervesce ’ The terms dermatitis  and eczema are often used as synonyms but, the term eczema is preferably used for exudative dermatitis 8

       It argues that atopic eczema cannot be a purely genetic disease , otherwise why should it clear at all.9 The majority of people with atopic dermatitis experience mild disease , whereas only a small proportion have a severe from of the disease10. The major atopic disorders, eczema, allergic rhinitis and asthma, cause significant disease burdens worldwide11. Eczematoid rash is characterised by an erythematous scaly rash with an ill-defined border in different phases, acute, subacute and chronic12.

 LIST OF REFRENCES:                                                                           

1.      Bieber T. Pathophysiology and Clinical Aspects of Atopic Dermatitis. Ann Dermatol. 2010; 22(2): 125-137.

2.      Civelek E, Sahiner UM ,Yuksel H, Boz AB, Orhan F, Uner A et al. Prevalence, Burden, and Risk Factors of Atopic Eczema in School children Aged 10-11 Years: A National Multicenter Study .2011 ;(4):270-277.

3.      Lee H J , Son S W , Cho S H, A Comprehensive Review of the Treatment of Atopic Eczema .Allergy Asthma Immunol Research.2016;8(3):189-190.

4.      Ghani N. Qarabadeen Najmul Gani. New Delhi: CCRUM. Ministry of Health and Family Welfare; Govt. of India; 2010:1037.

5.      Boon NA, Colledge NR, Walker B Hunter JAA. Davidson’s Principles & Practice of Medicine. 20th Edition. Churchill Livingstone Elsevier. 2006; 1283-1287.

6.      Majoosi IA. Kamilus Sana. Vol 2. Idara Kitabush Shifa. New Delhi. 2010; 243.

7.      Arzani H A. Tibbe Akbar. Urdu Translation by Hk M Hussain, Deoband: Faisal, YNM: 700-701.

8.      Shah S N, Paulanand M, Billimoria AR, Kamath SA, Karnad DR, Munjal YP. et al. API Textbook of Medicine Vol-II 8th Edition. Mumbai: The association of Physicians of India; 2009:1280-1284.

9.      Williams HC, Strachan DP. The natural history of childhood ecze­ma. Observations from the British 1958 birth cohort study. Br J Der­matol. 1998; 139: 834-839.

10.  Mgeladze N, Karseladze R, Dadeshidze I, Tsagareishvili G, Khojava K, Tsagareishvili N.Clinical controlled study of ascancol: effect on atopic dermatitis. 2005july/September;5(3):164-167.

11.  Allen J S, Jordan S, Storey M, Thornton A C, Gravenor B M, Garaiova I, Et al.Probiotics in the prevention of eczema: A randomized controlled trial;2014;99:1014-1019.

Dr.KK LO.Practical Approach for “Eczema”.The Hong Kong Medical Diary.2010; 15(11) :5-7. 
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