| CTRI Number |
CTRI/2025/07/092037 [Registered on: 30/07/2025] Trial Registered Prospectively |
| Last Modified On: |
30/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effectiveness of Homoeopathic Medicines in cases of Cutaneous Lichen Planus |
|
Scientific Title of Study
|
Effectiveness Of Individualized Homoeopathic Medicine In Management Of Cutaneous Lichen Planus - A Non- Controlled Experimental 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 |
Dr Kalika Adhikrao Devakate |
| Designation |
MD (Homoeopath) PhD Scholar |
| Affiliation |
Dr. G. D. Pol Foundation, Y. M. T. Homoeopathic Medical College and Hospital, Kharghar - Navi Mumbai |
| Address |
K. E. S. Chandrakant Hari Keluskar Homoeopathic Medical College and Hospital, Khandala - Alibag, Raigad
Raigarh
MAHARASHTRA
402201
India |
| Phone |
9822950317 |
| Fax |
|
| Email |
kalikadevakate@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Swati Bhagwat |
| Designation |
HOD and Professor Dept. Of HMM, Y.M.T Homoeopathic College, Kharghar - Navi Mumbai |
| Affiliation |
Dr. G. D. Pol Foundation, Y. M. T. Homoeopathic Medical College and Hospital, Kharghar - Navi Mumbai |
| Address |
Dr. G. D. Pol Foundation, Y. M. T. Homoeopathic Medical College and Hospital, Kharghar - Navi Mumbai
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9969337242 |
| Fax |
|
| Email |
swati_bhagwat_29@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Swati Bhagwat |
| Designation |
HOD and Professor Dept. Of HMM, Y.M.T Homoeopathic College, Kharghar - Navi Mumbai |
| Affiliation |
Dr. G. D. Pol Foundation, Y. M. T. Homoeopathic Medical College and Hospital, Kharghar - Navi Mumbai |
| Address |
Dr. G. D. Pol Foundation, Y. M. T. Homoeopathic Medical College and Hospital, Kharghar - Navi Mumbai
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9969337242 |
| Fax |
|
| Email |
swati_bhagwat_29@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Dr G D Pol Foundation, Y M T Homoeopathic Medical College and Hospital, Kharghar - Navi Mumbai, Institute Of Research Centre Affiliated To MUHS, Nashik |
|
|
Primary Sponsor
|
| Name |
Dr. Kalika Adhikrao Devakate |
| Address |
K. E. S. Chandrakant Hari Keluskar Homoeopathic Medical College and Hospital, Khandala - Alibag, Raigad |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Kalika Adhikrao Devakate |
KESCHKHMC Hospital OPD |
KES Chandrakant Hari Keluskar Homoeopathic Medical College and Hospital, Khandala - Alibag, Raigad
Raigarh
MAHARASHTRA |
9822950317
kalikadevakate@gmail.com |
| Dr Kalika Devakate |
YMT Homoeopathic Medical College OPD |
Dr G D Pol Foundation, YMT Homoeopathic Medical College and Hospital, Kharghar - Navi Mumbai
Raigarh
MAHARASHTRA |
9822950317
kalikadevakate@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| YMT Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L430||Hypertrophic lichen planus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized Homoeopathic Medicines |
Dose liquid dilution and single or repeated as per case requirement. Frequency from single dose to 1 to 3 times daily based on susceptibility and clinical response. Potency selected according to case parameters i.e cm dm lm. Duration up to 12 months with followup every 15 days or as needed. |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients above 18 years
2. Male and Female patients of cutaneous lichen planus
3. Patients irrespective of ethnic group, socio economic status and occupation will be included.
4. Clinically pre - diagnosed patients of cutaneous lichen planus.
5.1. Acute eruptive Lichen Planus (EA91.0)
5.2. Hypertrophic Lichen Planus (EA91.1)
5.3. Follicular Lichen Planus (EA91.2)
5.4. Sub acute Lichen Planus (EA91.6) |
|
| ExclusionCriteria |
| Details |
1. Pregnant female and lactating mother
2. Immunocompromised patients.
3. Patients of cutaneous lichen planus who have received any oral or topical medications for cutaneous lichen planus 2 months prior to our treatment.
4.1. Lichen planus of genital skin and mucous membrane (EA91.3)
4.2. Lichen planus and lichenoid reaction of oral mucosa (EA91.4)
4.3. Lichen planus of nail (EA91.5)
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Improved
2. Not Improved |
1. Improved - if LPSI score is less than pre treatment LPSI score
2. Not Improved - if LPSI score is same or more than pre treatment LPSI score |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessed as per - Lichen Planus Severity Index A New Valid Scoring System. |
Assessed as per - Lichen Planus Severity Index A New Valid Scoring System. |
|
|
Target Sample Size
|
Total Sample Size="51"
Sample Size from India="51"
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
|
N/A |
|
Date of First Enrollment (India)
|
15/08/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/08/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="3"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [kalikadevakate@gmail.com].
- For how long will this data be available start date provided 25-07-2025 and end date provided 25-07-2028?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Data will be shared upon request via email after de-identification, for academic purposes only.
|
|
Brief Summary
|
1.Case taking according to standard case report form proforma to form totality with special emphasis on individualizing case. 2. Standard literature and reference books on Homoeopathic Materia Medica, Medicine books, Pathology books, standard Homoeopathic journals, research papers will be considered. 3. Standard software will be used for repertorization of case. 4. Lichen planus severity index a new valid scoring system will be used to assess the severity pre and post treatment. |