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CTRI Number  CTRI/2024/12/077998 [Registered on: 12/12/2024] Trial Registered Prospectively
Last Modified On: 11/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Single Arm Study 
Public Title of Study   Homoeopathic treatment for Tinea versicolor among patients of early adulthood 
Scientific Title of Study   Effectiveness of individualized homoeopathic medicine in the treatment of Tinea Versicolor using Kents Repertory among the patients of early adulthood A pre-post 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 Sanjay Sikder 
Designation  Post graduate trainee 
Affiliation  Mahesh Bhattacharyya Homoeopathic Medical College and Hospital 
Address  Department of Repertory, Dr.B.N. Chakraborty Sarani, Doomurjola, Howrah, West Bengal

Haora
WEST BENGAL
711104
India 
Phone  8918025473  
Fax    
Email  sanjay981997@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Pradip Kumar Bairi 
Designation  Professor, HOD 
Affiliation  Mahesh Bhattacharyya Homoeopathic Medical College and Hospital 
Address  Department of Repertory, Dr.B.N. Chakraborty Sarani, Doomurjola, Howrah, West Bengal

Haora
WEST BENGAL
711104
India 
Phone  9433122932  
Fax    
Email  drpkbairi@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Pradip Kumar Bairi 
Designation  Professor, HOD 
Affiliation  Mahesh Bhattacharyya Homoeopathic Medical College and Hospital 
Address  Department of Repertory, Dr.B.N. Chakraborty Sarani, Doomurjola, Howrah, West Bengal


WEST BENGAL
711104
India 
Phone  9433122932  
Fax    
Email  drpkbairi@gmail.com  
 
Source of Monetary or Material Support  
Mahesh Bhattacharyya Homoeopathic Medical College and Hospital, Dr.B.N. Chakraborty Sarani, Doomurjola, Howrah, 711104, West Bengal, India 
 
Primary Sponsor  
Name  Dr Sanjay Sikder 
Address  Dr.B.N. Chakraborty Sarani, Doomurjola, Howrah-711104, West Bengal 
Type of Sponsor  Other [self] 
 
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 Sanjay Sikder  Mahesh Bhattacharyya Homoeopathic Medical College and Hospital  Dr.B.N. Chakraborty Sarani, Doomurjola, Howrah-711104, West Bengal
Haora
WEST BENGAL 
8918025473

sanjay981997@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Mahesh Bhattacharyya Homoeopathic Medical College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: B360||Pityriasis versicolor,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Individualized Homoeopathic Medicine  All patients enrolled in the study will receive individualized homoeopathic medicine. Medicine will be given orally. Doses will based on every patients those who will be enrolled. Centesimal potencies will be used. All medicines procured are GMP-certified. Participants will receive dietary and lifestyle advice to support overall health. 
Comparator Agent  Not applicable  Not applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  39.00 Year(s)
Gender  Both 
Details  Patients presenting with clinical features of Tinea versicolor.
Patient whose skin scraping sample shows KOH Test positive.
Patients of young adult age group 18-39yrs.
Patients who are not under any homoeopathic treatment for last four weeks. 
 
ExclusionCriteria 
Details  Pregnant and lactating mothers.
Diagnosed cases of unstable psychiatric illness or other life threatening issues affecting quality
of life.
Patients with underlying malignancy or any such conditions which needs emergency medical
intervention.
History of using any topical lotion or ointment for treatment that condition.  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Assessment the effectiveness of Individualized Homoeopathic Medicine using Kent’s
Repertory.
To assess the changes of sign of TV using Rating scale of Pityriasis versicolor pigmentation
percentage. 
Each patient will get follow-up for at least 3
months at the interval of 4 weeks. 
 
Secondary Outcome  
Outcome  TimePoints 
Changes in quality of life using DLQI Questionnaire.
Assessment the presence of hyphae on skin using KOH Test after intervention. 
Each patient will get follow-up for at least 3
months at the interval of 1 month 
 
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)   22/12/2024 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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  
INTRODUCTION:
Tinea versicolor or Pityriasis versicolor [1F2D.0 (ICD-11)] is a fungal infection that causes small patches of discolored spots on human skin. It is a superficial fungal infection caused by Malassezia (M. globose, M. furfur). It results from the over activity of the fungal growth on skin. This fungus is a part of the normal skin flora but it can cause disease when it converts to its pathogenic hyphal form which most localized to stratum cornium of the skin. Certain Genetical & Environmental, immunosuppressive factors can predispose to this pathogenic conversion and contribute to the development of disease. This is a chronic usually asymptomatic infection, although some patient experience mild pruritus. Epidemiologically Tinea versicolor is a disease of worldwide in distribution, but it is the most prevalent in tropical countries with hot and humid climate. Subsequently prevalence in the cold climate countries is low. The prevalence of Tinea versicolor (TV) is about 50% in tropical countries and very low as less than 1.1% in cold climates countries such as Sweden. TV occurs more frequently in young adults probably due to the increase of sebum production by the sebaceous glands which allow for more lipid rich environment. Men and women are equally affected and there is no specific predominancy.
TV skin lesions are perifollicular (often coalescing), may be hypopigmented, hyperpigmented, or erythematous macules surmounted with branny scale, accentuated by scratching. The distribution of affected skin reflects the lipophilic nature of the fungus since the seborrheic areas (upper trunk, neck, and/or deltoid) are predominantly involved. 
In conventional medicine topical as well as oral treatment are present. But in Homoeopathy there is no specific drug is present for a particular disease (Tinea versicolor), but there are some symptoms that are presented by patients and according to that presentation different medicine is to be prescribe with the guidance of Homoeopathic Materia Medica as well as Homoeopathic Repertory.
 
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