| 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
|
|
|
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
|
|
|
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. |