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CTRI Number  CTRI/2021/02/031016 [Registered on: 04/02/2021] Trial Registered Prospectively
Last Modified On: 20/01/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Unani 
Study Design  Single Arm Study 
Public Title of Study   Effect of Unani Treatment in Lichen Planus 
Scientific Title of Study   Efficacy of Majoon and Tila Barse Aswad in Lichen planus - An open labelled single arm clinical study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sumbul Nida 
Designation  P.G Scholar 
Affiliation  National Institute of Unani Medicine 
Address  Department of Amraze Jild wa Tazeeniyat, National Institute of Unani Medicine Kottigepalya main magadi road Bangalore

Bangalore
KARNATAKA
560091
India 
Phone  7906660535  
Fax    
Email  drsumbul4nida@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Prof Mansoor Ahmad Siddiqui 
Designation  professor 
Affiliation  National Institute of Unani Medicine 
Address  Department of Amraze Jild wa Tazeeniyat, National Institute of Unani Medicine Kottigepalya main magadi road Bangalore

Bangalore
KARNATAKA
560091
India 
Phone  9448124054  
Fax    
Email  mansoorsiddiquidr@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Sumbul Nida 
Designation  P.G Scholar 
Affiliation  National Institute of Unani Medicine 
Address  Department of Amraze Jild wa Tazeeniyat, National Institute of Unani Medicine Kottigepalya main magadi road Bangalore

Bangalore
KARNATAKA
560091
India 
Phone  7906660535  
Fax    
Email  drsumbul4nida@yahoo.com  
 
Source of Monetary or Material Support  
National Institute of Unani Medicine kottigepalya main magadi road Bangalore-560091 Karnataka 
 
Primary Sponsor  
Name  National Institute of Unani Medicine 
Address  National Institute of Unani Medicine Kottigepalya main magadi road Bangalore 
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 
Sumbul Nida  National Institute of Unani Medicine  Department of Amraze Jild Wa Tazeeniyat, National Institute of Unani Medicine Kottigepalya main magadi road Bangalore 560091
Bangalore
KARNATAKA 
7906660535

drsumbul4nida@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee for Biomedical Research NIUM Bangalore  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L439||Lichen planus, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Majoon for oral intake and Tila Barse Aswad for Local application  All the ingredients of Majoon(Haleela kabli,Haleela Siyah,Aftimoon,Maweez munaqqa)in Equal quantity are ground and sieved and then doughed into the Maweez munaqqa and in Tila Barse Aswad kaner leaves boils in sesamum oil then grind the leaves and add more oil in this paste and add melted bee wax then add sulphur into it.complete mixture is kept in sunlight. Majoon will be administered 10gm twice a day orally and tila Barse Aswad administered locally according to requirement. duration of therapy is 42 days. 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Cases of Lichen Planus.
2.Patients of both genders.
3.Patients in the age group of 18 years to 60 years.
4.Patients are willing to be a part of our study.
 
 
ExclusionCriteria 
Details  1.Patient below and above the age of 18 years and 60 years.
2.Patient suffering from any other type of skin diseases like psoriasis, Eczema, Seborrheic Dermatitis, dermatophytosis, LSC and Lupus Erythematosus.
3.Patient suffering from systemic and metabolic diseases like DM, severe asthma, Cardiac diseases, Chronic Renal failure.
4.Pregnant & Lactating Women.
5.Patients are not willing to be a part of study.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1.Lichen Planus Severity Index18
2.Investigator assessment using Photograph
3.Itching Severity on VAS20
 
At Baseline and at 6th week
 
 
Secondary Outcome  
Outcome  TimePoints 
1.Dermatological Life Quality Index (DLQI)  At Baseline and 6th week  
 
Target Sample Size   Total Sample Size="23"
Sample Size from India="23" 
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)   01/03/2021 
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)?  

Response - NO
Brief Summary  

Lichen planus(LP) is an idiopathic subacute or chronic inflammatory, Autoimmune, Mucocutaneous, Papulosquamous disorder that may affect the skin, scalp, nails and mucus membrane. Cutaneous lichen planus clinically characterized by distinctive violaceous, polygonal flat-topped pruritic papules which lines (Wickham’s striae) visible on the surface.

The exact incidence and prevalence of lichen planus are unknown, but the overall prevalence is believed to be somewhat 0.2% to 1% of the general population. Estimates between 0.14% and 0.27% have been reported worldwide and 0.38% in India. There is no sexual predilection and two- third of cases occurs between the 3rd and 6th decade of age4,6 But Females are more prone to develop and  usually affecting in their 50s and 60s whereas males develop lichen planus at a somewhat earlier age. It develop adverse effects on quality of life in more than 90% of patients like psychological stress, social phobia, obsessive thoughts and cosmetologically disfigurement. There is strong association between depression and quality of life in both the gender.

In conventional medicine management of Lichen planus is challenging and can be discouraging for both, the patients and physician. Various oral drugs or topical corticosteroids have been used for treatment but many of recommended treatment lack conclusive evidence or efficacy and also show many side effects, drug resistance and interfere with immunity. So, alternative therapeutic approaches are being carried out. Through Unani herbal medicines could be solve by effective treatment with fewer side effects, enhance productivity, improve Quality of life.

In Unani System of medicine, direct description on LP is not available as such but according to its clinical presentation can be considered as Barse Aswad. The need of this study is to evaluate effectiveness of this classical unani preparation clinically, in this disease. So, Keeping all these in mind this study is planned for management of lichen planus with Unani medicine. Further according to the involvement of Madda we could relate it with khilt-e-saudawi (Melancholic humour). 

So, according to this hypothesis it can be treated effectively with Majoon to expel out excessive and abnormal Sauda ( Melencholic Humour) from the whole body and appropriate Local application for symptomatic relief like itching and scaling etc. The Majoon used in this study contains Halela Siyah, Haleela Kabli, Aftimoon, Mawez munaqqa have Munzij Sauda Property and Tila Barse Aswad contains Barge Kaner, Mom, Gandhak and Roghan-e-kunjad to be administered orally and locally respectively.

Procedure of study: Patients with clinical features of LP fulfilling the inclusion criteria will be enrolled for the clinical trial. After obtaining their written informed consent and subsequently will be included in the study. The patients will be prescribed test drug in the form of Majoon orally and Tila for local application for 42 days with follow ups for assessment on every 14th day(14th day, 28th day, 42th day) . Before and after completion of trial, photographs of skin lesions will be taken for assessment  by an expert panel. The pre and post treatment objective findings (effects) will be assessed statistically.


 
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