| CTRI Number |
CTRI/2025/09/094543 [Registered on: 10/09/2025] Trial Registered Prospectively |
| Last Modified On: |
09/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of Homoeopathic medicine in the treatment of Cutaneous Lichen Planus |
|
Scientific Title of Study
|
Effectiveness of Individualized Homoeopathic Treatment in the Management of Cutaneous Lichen Planus- A Prospective Single-Arm Clinical 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 Kago Dolya |
| Designation |
Junior Resident |
| Affiliation |
Nehru Homoeopathic Medical College and Hospital |
| Address |
Department of Organon of Medicine and Homoeopathic Philosophy, Nehru Homoeopathic Medical College and Hospital, B-Block,Defence Colony,New Delhi
South
DELHI
110024
India |
| Phone |
6009717068 |
| Fax |
|
| Email |
kagodolya97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bipin Jethani |
| Designation |
HOD (Department of Organon of Medicine and Homoeopathic Philosophy |
| Affiliation |
Nehru Homoeopathic Medical College and Hospital |
| Address |
Department of Organon of Medicine and Homoeopathic Philosophy, Nehru Homoeopathic Medical College and Hospital, B-Block,Defence Colony,New Delhi
South
DELHI
110024
India |
| Phone |
9810146343 |
| Fax |
|
| Email |
drbipin.jethani@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kago Dolya |
| Designation |
Junior Resident |
| Affiliation |
Nehru Homoeopathic Medical College and Hospital |
| Address |
Department of Organon of Medicine and Homoeopathic Philosophy, Nehru Homoeopathic Medical College and Hospital, B-Block,Defence Colony,New Delhi
South
DELHI
110024
India |
| Phone |
06009717068 |
| Fax |
|
| Email |
kagodolya97@gmail.com |
|
|
Source of Monetary or Material Support
|
| Nehru Homoeopathic Medical College and Hospital,B-Block Defence Colony, New Delhi- 110024 |
|
|
Primary Sponsor
|
| Name |
Nehru Homoeopathic Medical College and Hospital |
| Address |
B-Block, Defence Colony, New Delhi 110024 |
| 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 Kago Dolya |
Nehru Homoeopathic Medical College and Hospital |
Department of Organon of Medicine and Homoeopathic Philosophy, Nehru Homoeopathic Medical College and Hospital, B-Block,Defence Colony,New Delhi
South
DELHI |
06009717068
kagodolya97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Nehru Homoeopathic Medical College and Hospital Ethics Committee |
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 |
Individualized Homoeopathic Medicine |
In this study, the intervention will consist of individualized homoeopathic treatment prescribed on the basis of detailed case taking, analysis, evaluation, and repertorisation in accordance with Hahnemann’s guidelines (§83–§104, Organon of Medicine). The final remedy will be selected after consulting standard Homoeopathic Materia Medica, with miasmatic analysis taken into consideration where indicated. Medicines will be procured from the pharmacy of Nehru Homoeopathic Medical College and Hospital, or GMP-certified sources if unavailable. Remedies will be administered in centesimal (C) or LM potencies via oral route depending on the susceptibility and clinical condition of the patient.The repetition and potency will be decided individually, based on severity of symptoms, susceptibility, and response to treatment.Patient will be called for followup after every 15 days. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with signs and symptoms of cutaneous Lichen Planus.
2.Age between 18-70 years.
3.Patients willing to give written informed consent.
4.Both genders.
|
|
| ExclusionCriteria |
| Details |
1.Patients who tested positive for the Hepatitis C Virus antibody test.
2.Pregnant and lactating women.
3.Patient with advanced systemic illness.
4.Patient with any psychiatric illness.
5.Patients with mucosal involvement (oral, genital, anal).
6.Immunocompromised individuals.
7.Patient of drug abuse.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in the extent and intensity of lesions as per LPSI score. |
At baseline and at 24 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in quality of life measured by DLQI. |
At baseline & at 24 weeks |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
13/10/2025 |
| 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="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
|
This prospective, open-label, single-arm clinical study is designed to evaluate the effectiveness of individualized homoeopathic treatment in the management of cutaneous lichen planus. The trial will be conducted at Nehru Homoeopathic Medical College & Hospital, New Delhi, with a total of 40 patients aged 18–70 years, diagnosed with cutaneous lichen planus (excluding mucosal involvement), recruited from the outpatient department. Each participant will undergo detailed case-taking, repertorization, and individualized prescription of homoeopathic medicines, administered orally, with dosage and repetition based on symptom severity and patient susceptibility. The duration of the study is 12 months, comprising 6 months of enrollment and 6 months of follow-up. Effectiveness will be assessed primarily through the reduction in disease severity measured by the Lichen Planus Severity Index (LPSI) score, and secondarily by improvement in patient quality of life measured by the Dermatology Life Quality Index (DLQI). Statistical analysis will be performed with significance set at p less than 0.05. Institutional Ethical Committee clearance and CTRI registration will be obtained, informed consent will be taken from all participants, and patient confidentiality and safety will be strictly maintained. |