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
|
|
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
|
|
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. |