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CTRI Number  CTRI/2025/08/093913 [Registered on: 29/08/2025] Trial Registered Prospectively
Last Modified On: 28/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Medical Device
Unani
Diagnostic 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Evaluate the safety and efficacy of Oral and Local Unani Formulations in the Management of Eczema 
Scientific Title of Study   Evaluation of the safety and efficacy of Sharbat Unnab and Topical Unani formulation (Tila) in the management of Nar farsi(Eczema): An open label randomized controlled study. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Nadeem Iqbal 
Designation  MD SCHOLAR 
Affiliation  Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital 
Address  Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital Ayush Campus Kolar Bypass road Bhopal Madhya Pradesh

Bhopal
MADHYA PRADESH
462003
India 
Phone  08896171194  
Fax    
Email  drnadeemiqbal5@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Mohammad Anzar Husain 
Designation  Professor and HOD 
Affiliation  Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital 
Address  Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital Ayush Campus Kolar Bypass road Bhopal Madhya Pradesh

Bhopal
MADHYA PRADESH
462003
India 
Phone  7000097052  
Fax    
Email  mohdanzarhusain@yahoo.in  
 
Details of Contact Person
Public Query
 
Name  Nadeem Iqbal 
Designation  MD SCHOLAR 
Affiliation  Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital 
Address  Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital Ayush Campus Kolar Bypass road Bhopal Madhya Pradesh

Bhopal
MADHYA PRADESH
462003
India 
Phone  08896171194  
Fax    
Email  drnadeemiqbal5@gmail.com  
 
Source of Monetary or Material Support  
Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital Bhopal Madhya Pradesh Medical Science University Jabalpur Madhya Pradesh, India 462003 
 
Primary Sponsor  
Name  Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital  
Address  Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital Ayush Campus Kolar Bypass road Bhopal Madhya Pradesh India 462003 
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 Nadeem Iqbal  Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital   OPD 5 ground floor Department of Amraze Jild wa Tazeeniyat Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital Ayush Campus Kolar Bypass road Bhopal Madhya Pradesh
Bhopal
MADHYA PRADESH 
08896171194

drnadeemiqbal5@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital  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 
Comparator Agent  Betamethasone valerate 0.1% cream  Betamethasone valerate 0.1% cream is given to the patient, and is advised to apply a thin layer of the cream on the eczematous area twice daily for 42 days.  
Intervention  Sharbat Unnab and 5 Unani drugs composed in the form of a liniment(tila)  Sharbat unnab 20 ml is to be taken by the patient twice daily after meals for 42 days. a liniment(tila) is prepared from Safeda kashgari (soap stone), murdarsang (Plumbous oxide), sandal safaid (Santalum album), Kafoor ( Cinnamomum camphora) and Arq gulab (Rosa damascene) that is given to the patient and the patient is advised to apply a thin layer of it on the eczematous area twice daily for 42 days. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Patients willing to get enrolled in the study with informed consent & follow the protocol.
2. Diagnosed cases of eczema as per Hannifin and Rajka criteria.
3. Patients willing to attend treatment schedules regularly. 
 
ExclusionCriteria 
Details  1. Pregnant or lactating women.
2. Diabetic patients.
3. History of unstable pulmonary /cardiovascular / hepato-renal dysfunction or any other serious comorbid condition & known cases of immunocompromised states like AIDS etc.
4.Patients not willing to attend treatment schedule regularly.  
 
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 
1. Patient Oriented Eczema Measure (POEM)
 
At baseline , 14th , 28th and 42nd day 
 
Secondary Outcome  
Outcome  TimePoints 
1. SCORing Atopic Dermatitis (SCORAD)
2.Eczema Area Severity Index (EASI)
3. Dermatology Life Quality Index (DLQI) 
At baseline , 14th , 28th and 42nd day 
 
Target Sample Size   Total Sample Size="44"
Sample Size from India="44" 
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)   08/09/2025 
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="0"
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, also known by the names of Nar farsi, Chajjan or Akota in the Unani system of medicine. The word Nar farsi which means Intense itching and burning was originally used in Persia, or the individual who used it was from Persia. The Greek term ekzein which means to boil forth and effervescence is where the word eczema first appeared in writing in AD 543. It can affect anybody, regardless of age or gender and is clinically characterized by varying degrees of clinical manifestations including dryness, erythema, excoriation, exudation, fissuring, hyperkeratosis, lichenification, papulation, scaling and vesiculation. In pediatric and adult studies, the prevalence of atopic dermatitis ranged from 0.98% to 9.2%. Eczema is a disabling condition that causes its sufferers to have socioeconomic issues including insomnia, anxiety, personality disorders, and difficulty carrying out everyday tasks. Patient’s quality of life is diminished by this illness. Conventional treatment includes topical corticosteroids to manage eczema and moisturizers or emollients to relieve dry skin. Several adverse effects, including skin atrophy, hair loss, weight gain, nephrotoxicity, hepatotoxicity, etc. have been linked to the use of systemic corticosteroids. This leads us to look for alternative safe and effective option to treat Nar farsi. Unani system of Medicine is very ancient and rich system of medicine. Though the ancient Unani physicians successfully treated Nar farsi and mentioned their experiences in Unani classical literature but their proper documentations on the recent scientific parameters is yet to be done, in order to convert these experiences into evidences to benefit the masses with confidence. Keeping in view of the fact this study is designed to clinically evaluate the safety and efficacy of an Unani ancient formulation on scientific parameters.

 
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