| CTRI Number |
CTRI/2023/01/049022 [Registered on: 16/01/2023] Trial Registered Prospectively |
| Last Modified On: |
13/01/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Homoeopathic medicine plays a vital role in the treatment of Tinea and is very effective in in controlling recurrence too. |
|
Scientific Title of Study
|
Evaluating the Role of LM Potency in Treatment of Tinea Cruris and Tinea Corporis in Rural Area. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jwalantkumar Prajapati |
| Designation |
Reader |
| Affiliation |
Smt Malini Kishore Sanghvi Homoeopathic Medical College |
| Address |
Opp Sumeru Navkar Tirth Karjan amod road miyagam karjan
Vadodara
GUJARAT
391240
India |
| Phone |
9824509219 |
| Fax |
|
| Email |
jwalantprajapati@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hema Parikh |
| Designation |
Professor |
| Affiliation |
Smt Malini Kishore Sanghvi Homoeopathic Medical College |
| Address |
Opp Sumeru Navkar Tirth Karjan amod road miyagam karjan
Vadodara
GUJARAT
391240
India |
| Phone |
9825944977 |
| Fax |
|
| Email |
drhmparikh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jwalantkumar Prajapati |
| Designation |
Reader |
| Affiliation |
Smt Malini Kishore Sanghvi Homoeopathic Medical College |
| Address |
Opp Sumeru Navkar Tirth Karjan amod road miyagam karjan
Vadodara
GUJARAT
391240
India |
| Phone |
9824509219 |
| Fax |
|
| Email |
jwalantprajapati@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Smt Malini Kishore Sanghvi Homoeopathic Medical college
Opp Sumeru Navkar Tirth Karjan amod road miyagam karjan
Vadodara
GUJARAT
391240
India |
|
|
Primary Sponsor
|
| Name |
Dr Jwalantkumar Prajapati |
| Address |
Smt Malini Kishore Sanghvi Homoeopathic Medical college
opp Sumeru Navkar Tirth
Miyagam Karjan Vadodara |
| 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 Hema Parikh |
Smt Malini Kishore Sanghvi Homoeopathic Medical College |
Department of Dermatology Room Number 11 Ground Floor
Opp Sumeru Navkar Tirth Amod karjan road miyagam karjan
Vadodara
GUJARAT |
9825944977
drhmparikh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical committee, Smt. Malini Kishore Sanghvi Homoeopathic Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L088||Other specified local infections of the skin and subcutaneous tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Homoeopathic Medicine |
Homoeopathic medicine [acute medicine chronic medicine anti miasmatic medicine] in LM potency
dose and frequency as per the assessment of susceptibility
total duration- till patient improve symptomatically
route of administration - oral |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed with Tinea cruris or Tinea corporis or both
Patients belong to any age group
|
|
| ExclusionCriteria |
| Details |
k/c/o Comorbid Clinical conditions like DM, immunocompromised person,
Cushing syndrome, on immunosuppression drugs
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effects of Homoeopathic Medicines in LM potency in the management of Tinea cruris and tinea corporis in rural areas. |
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To explore commonly coming Medicines in the treatment of tinea cruris and tinea corporis.
|
24 weeks |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
16/01/2023 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Patients come with TINEA CRURIS AND TINEA CORPORIS most
frequently for treatment in the dermatology OPD. Its prevalence is increasing day by day. It is spread easily and fast to another person also. People are most bothered by this disease as it spread to any area of the body. Many times disease creates an embarrassing situation for patients.
Even
after taking allopathic treatment from various Dermatologists and for a longer
duration, there was no expected result. The disease remains hidden or silent for
some time and again comes back at the same location or a different location. The disease came back in a more vigorous form. Ultimately even after spending so much time
and money patient did not get permanent improvement. The homoeopathic treatment avoids the recurrence of the disease, suppression of disease, and cures the disease from root. |