| CTRI Number |
CTRI/2025/01/078946 [Registered on: 17/01/2025] Trial Registered Prospectively |
| Last Modified On: |
17/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Utility Of Homoeopathic Medicines In Cases Of Warts |
|
Scientific Title of Study
|
Prospective Experimental Study Of Homoeopathic Intervention For Management Of Warts By Using Likert Scale |
| 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 Krupali Patel |
| Designation |
PG Scholar |
| Affiliation |
Rajkot Homoeopathic Medical College |
| Address |
Department of Practice of Medicine, Rajkot Homoeopathic Medical College, behind jainath complex, makkam chowk, Gondal road, Rajkot
Rajkot GUJARAT 360002 India |
| Phone |
9408539675 |
| Fax |
|
| Email |
pkrupalip@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Shailendra Bhamar |
| Designation |
Professor |
| Affiliation |
Rajkot Homoeopathic Medical College |
| Address |
Department Of Practice of Medicine, Rajkot Homoeopathic Medical College, behind jainath complex, makkam chowk, Gondal road, Rajkot
Rajkot GUJARAT 360002 India |
| Phone |
9131331597 |
| Fax |
|
| Email |
shailendra.bhamar17970@paruluniversity.ac.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Krupali Patel |
| Designation |
PG Scholar |
| Affiliation |
Rajkot Homoeopathic Medical College |
| Address |
Department of Practice of Medicine, Rajkot Homoeopathic Medical College, behind jainath complex, makkam chowk, Gondal road, Rajkot
Rajkot GUJARAT 360002 India |
| Phone |
9408539675 |
| Fax |
|
| Email |
pkrupalip@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rajkot Homoeopathic Medical college, Attached with Sainath Hospital, Parul University, Rajkot, Gujarat, India, 360002 |
|
|
Primary Sponsor
|
| Name |
Rajkot Homoeopathic Medical College Attached with Sainath Hospital Parul university |
| Address |
Rajkot Homoeopathic Medical College, behind jainath complex , makkam chowk, Gondal road, Rajkot, Gujarat, India, 360002 |
| 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 Krupali Patel |
Rajkot Homoeopathic Medical College |
Department Of Practice Of Medicine, Rajkot Homoeopathic Medical College, B/H Jainath complex Makkam chowk , Gondal road , Rajkot ,Gujrat, 360002 Rajkot GUJARAT |
9408539675
pkrupalip@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Human Research - Rajkot Homoeopathic Medical College (RHMC), Parul University, Gujrat |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B079||Viral wart, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized Homoeopathic Medicine |
Individualized homoeopathic
medicine.
Duration : 9 Months
Mode of Administration: Oral (sublingual)
Selection of potency, dose and
repetition : individualised
medicine will be prescribed in 30, 200, 1 M potency. selection of dosage, potency and repetition will be according to susceptibility of patient and principles of organon of medicine |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged 18-65 years.
Both genders (Male and Female) will be considered.
Cases will be selected on Diagnostic criteria mainly done on basis of clinical history presentation and examination finding or pre diagnosed cases of warts.
Cases with Head, neck, hand region warts.
All socio-economical classes are considered.
|
|
| ExclusionCriteria |
| Details |
Patients with serious or irreversible pathological conditions, autoimmune conditions, life threatening conditions, psychiatric conditions.
Immune compromised patients, patients with other skin diseases with same manifestation.
Pregnant and lactating mothers.
Patients above 65 years and below 18 years of age.
Patients taking other therapeutic measures for warts and other skin disease.
Cases with warts of other types or at other location of warts.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| There will be some improvement after prescribing Homoeopathic Medicines |
There will be some improvement after prescribing Homoeopathic Medicines After 4-8 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
o Cure – complete clearance of number of warts with relief of all the symptoms without recurrence of complaints.
o Moderate improvement –partial clearance of number of warts with relief of all the symptoms without recurrence of complaints.
o No improvement / status quo – no change in warts and in any symptoms. |
There will be some improvement after prescribing homoeopathic medicines after 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 2 |
|
Date of First Enrollment (India)
|
16/07/2025 |
| 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 Yet Recruiting |
| 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
|
Warts are cutaneous neoplasms caused by papillomaviruses. More than 100 different human papillomaviruses (HPVs) have been described. A typical wart, verruca vulgaris, is sessile, dome-shaped, and usually about a centimeter in diameter. Its surface is hyperkeratotic, consisting of many small filamentous projections. In a study done in India , extremities were involved in 57.72%, head/neck was affected in 24.9%, genitals in 6.87% and trunk in 11.36%. Extremities were more commonly involved due to increased chances of trauma and consequent infection in these sites. the age of the patients ranged from 9-67 years where 82% of patients belonged to the 2nd to 4th decades, 75.5% of patients fell in the 11-40 years age group. This relatively increased prevalence of warts in this age group could possibly be the result of their increased propensity to trauma facilitated-inoculation. Occupational stratification showed the most common occupation group was students (32%), labourers (28%) and housewives (16%).The higher incidence among the students could be attributable to the fact that they are physically more active and therefore at a higher risk of damage to the stratum corneum that serves as an entry point for the human papillomavirus. While conventional medical treatments are widely employed, there is a growing interest in alternative approaches, such as homeopathic intervention. This study aims to prospectively evaluate the efficacy of homeopathic treatments in managing warts with use of Likert scale. Despite advancements in conventional medical treatments, some patients may experience limitations, adverse effects, or inadequate responses. The study aims to identify whether homeopathic intervention can offer a viable approach to address the limitations of conventional treatments. Homeopathy is known for its holistic approach to patient care, considering individual symptoms, lifestyle, and emotional well-being. Examining the holistic aspects of homeopathic treatments may contribute to a more comprehensive understanding of managing warts. Likert Scale is a recognized for assessment of warts. Utilizing this scale in the study will allow for a comprehensive evaluation of the effectiveness of homeopathic interventions in managing the of warts.The study seeks to evaluate not only the symptoms changes but also patient-reported outcomes, considering factors such as emotional well-being. Understanding these patient-centric outcomes will contribute to a more comprehensive assessment of the overall effectiveness of homeopathic interventions. In conclusion, explore alternative treatments, overcome limitations in current approaches, and provide a more holistic perspective on patient care. The use of established scales and analytical tools will ensure a rigorous evaluation of the efficacy of homeopathic interventions in managing warts. RESEARCH QUESTION: Whether the patient suffering from warts will get beneficial result after taking homoeopathic medicines? HYPOTHESIS: v Null Hypothesis (H0): There is no significant difference in the treatment outcomes for warts individuals receiving homoeopathic intervention v Alternative Hypothesis (H1): There is a significant difference in the treatment outcomes for warts individuals receiving homoeopathic intervention |