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CTRI Number  CTRI/2024/02/062979 [Registered on: 21/02/2024] Trial Registered Prospectively
Last Modified On: 09/01/2024
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   Evaluation of efficacy and safety of Polyherbal Unani formulations in the management of Eczema 
Scientific Title of Study   Evaluation of efficacy and safety of Polyherbal Unani formulations, ItrÄ«fal Shahtara orally and Marham Kharish Jadeed topically 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  Madiha Akhtar 
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  9958904901  
Fax    
Email  madihaakhtar23@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Munawwar Gauri 
Designation  Assistant professor 
Affiliation  Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital 
Address  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
462003
India 
Phone  9981817255  
Fax    
Email  mgauri52@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Munawwar Gauri 
Designation  Assistant professor 
Affiliation  Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital 
Address  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
462003
India 
Phone  9981817255  
Fax    
Email  mgauri52@gmail.com  
 
Source of Monetary or Material Support  
Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital and Madhya Pradesh Medical Science University Jabalpur 
 
Primary Sponsor  
Name  Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital Ayush  
Address  Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital Ayush Campus kolar Bypass Road Bhopal Madhya Pradesh 
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 
Madiha Akhtar  Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital  OPD No.5 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 
9958904901

madihaakhtar23@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committe 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: L20-L30||Dermatitis and eczema,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Betamethasone Valerate 0.1% cream  Betamethasone Valerate 0.1% cream is to be applied as athin layer on the affected part twice daily for 6 weeks. 
Intervention  Itrifal Shahtara and Marham Kharish Jadeed  Itrifal Shahtara is to be taken 10 grams with water at bed time daily for 6 weeks and Marham Kharish jadeed is to be applied as a thin layer on the affected part twice daily for 6 weeks. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients who are willing and able to comply with the scheduled visits and treatment plan, laboratory testing and other study procedure and capable of providing a signed informed consent form indicating the subject has been informed of all pertinent aspects of the study. 
 
ExclusionCriteria 
Details  1.Patients with an evidence of clinically significant and uncontrolled systemic illness.
2.Patients with a current diagnosis of active skin disease (e.g., psoriasis, lupus erythematosus) or skin infection (bacterial, fungal or viral) especially in place of eczema at the same time.
3. Patients who had been using topical steroids within past 14 days.
4. Pregnant and lactating women.
5. Patients who have a known history or clinically relevant allergy, in particular to any component of the study treatment.
6. Patients unlikely to cooperate with the study protocol. 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1.POEM (Patient Oriented Eczema Measure)
2. EASI (Eczema Area and Severity Index) Score
3. Pruritus NRS Assessment 
Baseline, 2nd week ,4th week and 6th week  
 
Secondary Outcome  
Outcome  TimePoints 
DLQI ( Dermatology Life Quality Index  Baseline & 6th week 
 
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)   01/03/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  01/03/2024 
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  is an inflammatory skin condition clinically characterized by erythema, papules, scaling, vesicles, fissures, hyperkeratosis and symptoms such as itch and pain. Over the span of 2009 – 2019, the highest prevalence of Atopic dermatitis was noted among Swedish children with 34%. In India, point prevalence of Atopic dermatitis is 6.75%  and that in older individuals was 11.4% .
Eczema can affect patient’s quality of life by causing emotional and physical distress, increased anxiety or social avoidance because of a continuous fear of being negatively judged, sleep deprivation, low self-esteem and even disability in more severe cases diminishing their occupational options.
In conventional system of medicine, the main treatment includes emollients and topical steroids  whose prolonged use causes adverse effects like atrophy, striae, rosacea, telangiectasia, rebound dermatitis along with resistance, early ageing and various toxicities or allergies to preservatives in topical creams . Keeping in view the adverse effects and limitations of conventional system of medicine along with an impaired quality of life, there is an imperative need to explore better treatment options. Unani system of Medicine is an ancient, time tested medicine with a rich literature of dermatology in which renowned physicians have elaborately mentioned and successfully treated various skin disorders. In order to treat eczema, ta’adil-e-khilt (normalization of causative humour), mubarridat (coolants), murattibat (humectants) , Musaffi-i-Dam (blood purifiers)  etc. were used by them. So, in order to transform the diversity of knowledge mentioned in the literature into valid evidences and for better documentation, this study has been conceived.
 
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