| CTRI Number |
CTRI/2025/03/082142 [Registered on: 11/03/2025] 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 Medicine in Cases of corns |
|
Scientific Title of Study
|
Prospective Experimental Study Of Homeopathic Intervention For Management Of Corns Assessed By Using MFPDI 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 Vaibhavee Dasadiya |
| 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 |
8849445515 |
| Fax |
|
| Email |
dasadiyavaibhavee31@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 Colloge , 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 Vaibhavee Dasadiya |
| 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 |
8849445515 |
| Fax |
|
| Email |
dasadiyavaibhavee31@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rajkot Homoeopathic Medical College attached with Sainath Hospital , Parul University,behind jainath complex, makkam chowk,gondal road,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
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vaibhavee Dasadiya |
Rajkot Homoeopathic Medical College attached with sainath hospital,Parul University |
Behind jainath complex,Makkam chowk,Gondal road,Rajkot ,Gujarat,India 360002.
Rajkot
GUJARAT |
8849445515
dasadiyavaibhavee31@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: L84||Corns and callosities, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized Homoeopathic Medicine |
Individualized homoeopathic
medicine. 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,Total Duration of study 9 months. |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patient age 18 to 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 corns.
Cases with foot corns.
All socio-economical classes are considered.
|
|
| ExclusionCriteria |
| Details |
Patients with other systemic illness like Diabetes Mellitus , Hypo or Hyper thyroidism.
Immune compromised patients, patient with other skin diseases with same manifestation and complicated study diabetic foot ulcer, septic Arthritis, Peripheral neuropathy, Osteoarthritis, Tinea Pedis.
Pregnant and lactating mothers.
Patients above 65 years and below 18 years of age.
Patients taking other therapeutic measures for corns and other skin diseases.
Patient with serious or irreversible pathological conditions, Autoimmune conditions, life threatening conditions and psychiatric illness.
Cases of Corns on other locations.
|
|
|
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
|
Outcome will be assessed at 6 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Cure – complete clearance of number of corns with relief of all the symptoms without recurrence of complaints.
Moderate improvement – partial clearance of corns with relief of all the symptoms without recurrence of complaints.
No improvement / Status que – no changes in corns 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
|
A corn, it is a popular lesion in the plantar surface of the foot (sole
of the foot). Corns due to physical agents which can affect the integument. They
produce a large percentage of dermatoses seen in general practice; the majority
of these dermatoses are minor problems, only a very small percentage are
serious. Apart from the intensity and quality of the physical agents ,the
sensitivity and vitality of the individual also plays an important part in the
bringing about the skin disorders.
Intermittent pressure and friction over a long period is likely to
produce a corn.it represents hyperkeratosis formed by nature to protect the
sensitivity part of the skin and the underlying structure from such pressure
and friction. A corn raised, uniform painless plaque pf hyperkeratosis appearing
on the hands and dorsum of feet.
The incidence of corns on feet has been reported to be ranging anywhere
from 14% to 48% individuals with darkly pigmented skin are more prone to
developing corns .corns may be symptomatic in as many as 18% of a working
population with mode age of symptomatic onset towards the end of working life.
Women suffered with corns more frequently than man. Dominant side and
variations in vertical loading does not appear to be influential etiology in
the formation of planter forefoot callus.
Through advancements in
conventional medical treatment there is last option for removal of corn with
surgical intervention .Due to surgical Intervention patient may goes to painful
condition and may suffer with side effects .even after removal there is no
surity that it not developed again due to this limitation, The Aim of this
prospective study to Homoeopathic Intervention can managed corns without any
surgical intervention.
Homoeopathy is
known for its holistic approach to patient care ,considering individual symptoms,
lifestyle and emotional well being. Examining the holistic aspects of
homoeopathic treatment may contribute to amore comprehensive understanding of
managing corns.
MFPDI scale is
recognized for assessment of corns. Utilizing this scale in the study will allow
for a comprehensive evaluation of the effectiveness of Homoeopathic
Intervention in managing of corns.
RESEARCH
QUESTION
Whether the
patient suffering from corns will get beneficial results after prescribing
homoeopathic medicine ?
HYPOTHESES :
v
Null
hypothesis(H0) : There will be no improvement in patients suffering from corns
after prescribing Homoeopathic medicines.
v
Alternative
hypothesis(H1): There will be improvement in patients suffering from corns
after prescribing Homoeopathic
medicines |