| CTRI Number |
CTRI/2024/08/073019 [Registered on: 28/08/2024] Trial Registered Prospectively |
| Last Modified On: |
24/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Homoeopathic treatment for Ringworm (Tinea) |
|
Scientific Title of Study
|
An Observational Prospective Study of
Homoeopathic Medicines in Treatment of
Dermatophytosis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vijay Sorathiya |
| Designation |
PG Scholar |
| Affiliation |
Rajkot Homoeopathic Medical College, Parul University |
| Address |
Department of Practice of Medicine, Rajkot Homoeopathic Medical College, Behind Jaynath Complex, Makkam Chok, gondal Road, Rajkot
Rajkot
GUJARAT
360002
India |
| Phone |
7567590466 |
| Fax |
|
| Email |
sorthiyavijay9237@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shailendra Bhamar |
| Designation |
HOD/ Professor |
| Affiliation |
Rajkot Homoeopathic Medical College, Parul University |
| Address |
Department of Practice of Medicine, Rajkot Homoeopathic Medical College, Behind Jaynath Complex, Makkam Chok, gondal Road, Rajkot
Rajkot
GUJARAT
360002
India |
| Phone |
9131331597 |
| Fax |
|
| Email |
shailendra.bhamar17970@paruluniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shailendra Bhamar |
| Designation |
HOD/ Professor |
| Affiliation |
Rajkot Homoeopathic Medical College, Parul University |
| Address |
Department of Practice of Medicine, Rajkot Homoeopathic Medical College, Behind Jaynath Complex, Makkam Chok, gondal Road, Rajkot
Rajkot
GUJARAT
360002
India |
| Phone |
9131331597 |
| Fax |
|
| Email |
shailendra.bhamar17970@paruluniversity.ac.in |
|
|
Source of Monetary or Material Support
|
| Sainath Homoeopathic Hospital |
|
|
Primary Sponsor
|
| Name |
Rajkot Homoeopathic Medical College |
| Address |
Department of Practice of Medicine, Rajkot Homoeopathic Medical College, Behind Jaynath Complex, Makkam Chok, gondal Road, Rajkot |
| 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 Vijay Sorthiya |
Sainath Homoeopathic Hospital |
Department of Practice of Medicine, Rajkot Homoeopathic Medical College, Behind Jaynath Complex, Makkam Chok, gondal Road, Rajkot
Rajkot
GUJARAT |
7567590466
sorthiyavijay9237@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, Gujarat |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B359||Dermatophytosis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualised Homoeopathic Medicine |
mode of administeration - oral
route potency - 30, 200, 1m,
10m frequency - every week
continuation till improvement is
seen |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Patients of both sexes and age group between 18 years.
All socio-economic classes irrespective of religion and caste will be
considered.
Pre-diagnosed or recently diagnosed cases having no improvementor relief
after treatment.
Cases coming with clinical presentation of dermatophytosis. |
|
| ExclusionCriteria |
| Details |
Complicated cases with advanced and irreversible pathological
conditions.
Cases of children not consider. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To ascertain effectiveness of Individualized
Homoeopathic Medicines in Dermatophytosis. |
it will be achieved within 9 months of period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the clinical presentation of Dermatophytosis. |
it will be achieved within 9 months of period |
|
|
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
09/09/2024 |
| 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="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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [sorthiyavijay9237@gmail.com].
- For how long will this data be available start date provided 01-09-2024 and end date provided 31-12-2025?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
The skin is the outmost and largest organ in the human body. it protects us from
microbes, elements, caries secretory and synthetic functions, helps regulate body
temperature , and permits the sensations of touch , heat and cold.
Out of 3 layers of the skin (Epidermis ,Dermis , Subcutaneous fat layer) the outer
most layer –Epidermis is constantly bombarded with external stimuli resulting into
shredding . in affords safety and insulation ,prevents dehydration , and senses of
environment .But irritants , infections ,and genetic mutations causes disease , ranging from
mild cosmetic conditions to serious illnesses such as cancer.
Dermatophytosis is caused by dermatophytes, keratinophilic fungi which includes
three genera : 1) Trichophyton, 2) Microsporum and 3) Epidermaphyton. It is comman in hot
humid climate.Extensive dermatophytosis can occur in diabetics and immunocompromised
(HIV Patients).
Dermatophytes are the most common agents of superficial fungal infections
worldwide and widespread in the developing countries, especially in the tropical and
subtropical countries like India, where the environmental temperature and relative humidity
are high. Other factors such as increased urbanization including the use of occlusive
footwear and tight fashioned clothes, has been linked to higher prevalence.
Where the modern system of medicines makes the usage of external application
like ointments, fungicides etc., in treatment of any skin infections like ring worm or
dermatophytosis infection, which leads to suppression or palliation. So the disease tends to
recur often and becomes a chronic disease. Removal of local symptoms of by external
application leads to rousing up the internal disease and the other symptoms that previously
existed in a latent state side by side with the local affection.
So there is a wide scope for proper management and treatment of
Dermatophytosis in Homoeopathy. So the study aims to give holistic approach to patient
care, considering individual symptoms,,lifestyle ,and emotional wellbeing..Examining the
holistic aspects of homoeopathic treatment may contribute to a more comprehensive
understanding of managing Dermatophytosis in our system of medicine ‘we do not treat the
disease but we treat the individual who is suffering’ |