| CTRI Number |
CTRI/2023/09/057463 [Registered on: 12/09/2023] Trial Registered Prospectively |
| Last Modified On: |
06/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Efficacy of unani formulation in the treatment of Lichen Planus |
|
Scientific Title of Study
|
Clinical study of Lichen Planus and therapeutic evaluation of Unani formulation in its management |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Malik Nuzhat Fatima |
| Designation |
PG Scholar |
| Affiliation |
Ajmal khan tibbya College AMU |
| Address |
Department of Amraz e Jild wa Zohrawiya Ajmal khan tibbya college and hospital
Faculty of Unani Medicine
Aligarh Muslim University Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
8439778035 |
| Fax |
|
| Email |
maliknuzhat2015@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mohammad Mohsin |
| Designation |
Assosiate Professor |
| Affiliation |
Ajmal khan tibbya college AMU |
| Address |
Department of Amraz e Jild wa Zohrawiya Ajmal Khan tibbya college and hospital Faculty of Unani Medicine
Aligarh Muslim University Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9412329198 |
| Fax |
|
| Email |
aqdas2005@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Malik Nuzhat Fatima |
| Designation |
PG Scholar |
| Affiliation |
Ajmal khan tibbya college AMU |
| Address |
Department of Amraz e Jild wa Zohrawiya Ajmal Khan tibbya College and hospital Faculty of Unani medicine
Aligarh Muslim University Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
8439778035 |
| Fax |
|
| Email |
maliknuzhat2015@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Amraz e jild wa Zohrawiya Ajmal Khan Tibbya College Aligarh Muslim University Aligarh |
|
|
Primary Sponsor
|
| Name |
Department of Amraz e Jild wa Zohrawiya |
| Address |
Department of Amraz e Jild wa Zohrawiya Near BSNL Office Aligarh Muslim University Aligarh |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Dr Malik Nuzhat Fatima |
Ajmal Khan Tibbya College and hospital |
Department of Amraz e Jild wa Zohrawiya Ajmal Khan tibbya college and hospital
Faculty of unani medicine AMU Aligarh
Aligarh
UTTAR PRADESH |
8439778035
maliknuzhat2015@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Ajmal Khan Tibbya College AMU |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L438||Other lichen planus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Deflazacort 6 milligram
And Mometasone cream |
Deflzacort 6 milligram one tablet twice a day for 15 days and Mometasone cream twice a day locally for 15 days |
| Intervention |
Majoon Musaffiye Aazam
Marham e hina |
Majoon Musaffiye Aazam (6gm) orally twice daily for 45 days and Marham e hina locally twice daily for 45 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Clinically diagnosed cases of Lichen Planus
Clinically stable patients
Patients of either sex
Patients having age group of 18 to 60 years
Patients who are willing to be a part of our study |
|
| ExclusionCriteria |
| Details |
Patient below and above the age of 18 years and 60 years
Patients who are not willing to be a part of study
Patient suffering from any other type of skin diseases like psoriasis Eczema Seborrheic Dermatitis dermatophytosis and Lupus Erythematosus
Patient suffering from systemic and metabolic diseases like DM and prediabetes severe asthma Cardiac diseases Chronic Renal failure
History of taking Conventional and Alternative Medicine therapy of present disease within the previous 7 days
Pregnant & Lactating Women |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement in Lichen Planus Severity Index
Improvement in Dermatology Life Quality Index.
Improvement in Photograph of affected area. |
Assessment of all parameters at inititation of the study at 0 day 15 day 30 day & 45 day of the study. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Itching
Scaling
Violaceous, Hyperpigmented Papules |
Assessment of all the symptoms at initiation of the study at 0 day 15 day 30 day & 45 day of the study. |
|
|
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)
|
15/09/2023 |
| 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
|
N/A |
|
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 a chronic inflammatory immune mediated disease that more frequently affects the skin and mucosa. Other areas that may be affected include the scalp, hair, nails and mucous membrane of the genitalia.Classic LP is characterized by violaceous, shiny, flat topped polygonal papules of variable sizes.Lichen planus is thought to be a T- cell mediated autoimmune disease, possibly targeting the basal keratinocyte. Exact Etiopathogenesis of LP is still unclear.The diagnosis of Lichen planus is clinical; however, it may be supplemented by histopathology.Aim of management of LP and its variants to control symptoms and to decrease time from onset to resolution. Treatment of cutaneous Lichen planus in conventional system of medicine is oral and topical corticosteroids, antihistamines, Vitamin A, Antibiotics and phototherapy /PUVA etc. There are some conditions mentioned in Unani system of medicine which has resemblance with lichen planus. It seems to be a type of Amraze Basoorat which is mentioned in almost all classical books.According to it’s clinical presentation it’s features mimics with the clinical presentation of basoor asfar and basoor aswad . The need of this study is to evaluate effectiveness of this classical unani preparation clinically, in this disease.
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