| CTRI Number |
CTRI/2024/12/078770 [Registered on: 30/12/2024] Trial Registered Prospectively |
| Last Modified On: |
27/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative Study of Thuja Internal vs. Local Application For treating the patients of Warts |
|
Scientific Title of Study
|
Comparative study of Thuja - Internal and local application in cases of Warts. |
| 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 Diti Jayeshbhai Patel |
| Designation |
M.D(Homoeopathy)Scholar |
| Affiliation |
C D Pachchigar College of Homoeopathic Medicine and Hospital |
| Address |
Department of Homoeopathic Pharmacy Division of MD 2nd Floor C D Pachchigar College of Homoeopathic Medicine and Hospital Surat Gujarat
Surat
GUJARAT
395001
India |
| Phone |
9898018149 |
| Fax |
|
| Email |
drditikumaripatel@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajesh Santosh Mahale |
| Designation |
Professor of Homoeopathic Pharmacy Department |
| Affiliation |
C D Pachchigar College of Homoeopathic Medicine and Hospital |
| Address |
Department of Homoeopathic Pharmacy Division of MD 2nd Floor C D Pachchigar College of Homoeopathic Medicine and Hospital Surat Gujarat
Surat
GUJARAT
395001
India |
| Phone |
9825290925 |
| Fax |
|
| Email |
rajeshmahale4u@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Diti Jayeshbhai Patel |
| Designation |
M.D(Homoeopathy)Scholar |
| Affiliation |
C D Pachchigar College of Homoeopathic Medicine and Hospital |
| Address |
Department of Homoeopathic Pharmacy Division of MD 2nd Floor C D Pachchigar College of Homoeopathic Medicine and Hospital Surat Gujarat
Surat
GUJARAT
395001
India |
| Phone |
9898018149 |
| Fax |
|
| Email |
drditikumaripatel@gmail.com |
|
|
Source of Monetary or Material Support
|
| C D Pachchigar College of Homoeopathic Medicine and Hospital
Near Anand Mangal Society Udhana Magdalla Road Surat 395001 Gujarat India |
|
|
Primary Sponsor
|
| Name |
C D Pachchigar College of Homoeopathic Medicine and Hospital |
| Address |
C D Pachchigar College of Homoeopathic Medicine and Hospital
Near Anand Mangal Society Udhana Magdalla Road Surat 395001 Gujarat India |
| Type of Sponsor |
Private 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 Diti Jayeshbhai Patel |
C D Pachchigar College of Homoeopathic Medicine and Hospital |
C D Pachchigar College of Homoeopathic Medicine and Hospital Surat 395001 Gujarat India
Surat
GUJARAT |
9898018149
drditikumaripatel@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Of C.D. Pachchigar College Of Homoeopathic Medicine And Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L088||Other specified local infections of the skin and subcutaneous tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Homoeopathic medicine THUJA will be given to one group |
Cases where Thuja is indicated will be given internally in different potencies like 30, 200 and 1M depending upon the susceptibility of the cases. |
| Comparator Agent |
Thuja medicine will be given internally with Thuja ointment as external application to another group |
Thuja medicine dose will be as per requirement of case and given internally in different potency depending upon the susceptibility of the patient and simultaneously Thuja ointment of SBL pharmacy will be advised to apply on the wart within time period of 9 months |
|
|
Inclusion Criteria
|
| Age From |
0.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Cases with Warts will be selected irrespective of age and gender.
previously surgically treated Warts will be taken. |
|
| ExclusionCriteria |
| Details |
Cases with irreversible pathological changes.
Cases with genital warts.
Cases with malignant changes.
Cases with irregular follow ups.
Cases can withdraw their consent anytime during the course of the study. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the effectiveness of Thuja in cases of warts |
Homoeopathic Medicine Dose As per Requirement of case through Sublingual Mode of Administration within Time Duration of 9 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study effectiveness of Thuja medicine as internal medicine and external application |
9 months |
|
|
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
07/01/2025 |
| 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="0"
Months="9"
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
|
Wart is the most common dermatological condition found amongst population.It is a common ,benign,epidermal lesion caused by Human Papilloma Virus infection.They are appear anywhere on the body in a variety of morphologies. Approximately 10% of people worldwide suffer from Warts.While uncommon in infancy and early childhood,overall prevalence among school-age children can reach 10-20%,peaking at 12 to 16 years.The Indian population exhibits a similar situation,with 46% of cases occurring in the 14-20 age range.India’s climate,which is primarily tropical,makes viral infections like Warts more common there.Many treatments including local applications as well as surgical excision are available in market.Since the development of Homoeopathic medicines, Thuja is well known as antisychotic medicine being useful in management of Warts. Up til now many researchers have been done related to effect of Thuja as Wart medicine but minimum study focused on role of Thuja as internal and external application in management of Warts.So,it is time to analyse the effect of prescribed Thuja medicine for Warts by dispensing it either in oral route and oral route along with external application. |