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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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

 
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