| CTRI Number |
CTRI/2025/03/082639 [Registered on: 18/03/2025] Trial Registered Prospectively |
| Last Modified On: |
18/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Other |
|
Public Title of Study
|
Comparing the Effectiveness of External application and Homoeopathic Medicines for Cracked Heels |
|
Scientific Title of Study
|
Examining the efficacy of external medicine and internal homoeopathic medications for heel cracks:A comparative 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 Krushangi Sakhiya |
| Designation |
PG Scholer |
| Affiliation |
Rajkot Homoeopathic Medical College,Parul University |
| Address |
Department of Practice of Medicine, Rajkot Homoeopathic
Medical College, behind jaynath complex, makkam chowk, Rajkot 360002 GUJARAT India
Rajkot GUJARAT 360002 India |
| Phone |
9723281383 |
| Fax |
|
| Email |
krushangisakhiya562@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Hitarth Mehta |
| Designation |
HOD/Professor |
| Affiliation |
Rajkot Homoeopathic Medical College,Parul University |
| Address |
Department of Practice of Medicine, Rajkot Homoeopathic
Medical College, behind jaynath complex, makkam chowk, Rajkot
GUJARAT 360002 India
Rajkot GUJARAT 360002 India |
| Phone |
9825340073 |
| Fax |
|
| Email |
hitarth.mehtarhmc@paruluniversity.ac.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Krushangi Sakhiya |
| Designation |
PG Scholer |
| Affiliation |
Rajkot Homoeopathic Medical College,Parul University |
| Address |
Department of Practice of Medicine, Rajkot Homoeopathic
Medical College, behind jaynath complex, makkam chowk, Rajkot 360002 GUJARAT India
Rajkot GUJARAT 360002 India |
| Phone |
9723281383 |
| Fax |
|
| Email |
krushangisakhiya562@gmail.com |
|
|
Source of Monetary or Material Support
|
| RAJKOT HOMOEOPATHIC MEDICAL COLLEGE, PARUL UNIVERSITY RAJKOT 360002 GUJARAT INDIA |
|
|
Primary Sponsor
|
| Name |
DEPARTMENT OF PRACTICE OF MEDICINE RAJKOT HOMOEOPATHIC MEDICAL COLLEGE, PARUL UNIVERSITY |
| Address |
DEPARTMENT OF PRACTICE OF MEDICINE RAJKOT HOMOEOPATHIC MEDICAL COLLEGE, B/H JAINATH COMPLEX, MAKKAM CHOWK, RAJKOT GUJARAT 360002 INDIA RAJKOT GUJRAT 360002 INDIA |
| 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 |
| Krushangi sakhiya |
Department of Practice of medicine,Rajkot homoeopathic medical college |
Department of Practice of Medicine,Rajkot homoeopathic medical college, B/H jaynath complex, Makkam chowk, Gondal road, Rajkot 360002 Rajkot GUJARAT |
9723281383
krushangisakhiya562@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 |
Homoeopathic Therapeutic Medicine/Local Application |
Homoeopathic Therapeutic Medicine selected by non repetorial Approach. Mode of Administration: Oral (sublingual)/Local Application Selection of potency, dose and repetition: individualised medicine will be presecribed 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 |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
11.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
-Case will be selected both acute and chronic cases,
-Cases with other systemic illness (known case of Diabetes, Palmoplanter psoriasis etc)
|
|
| ExclusionCriteria |
| Details |
1.Cases of under 0-10 years of age group.
2.Cases with irregular follow up.
|
|
|
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 imrovement after prescribing Homoeopathic Medicine in duration of 3 months |
There will be some imrovement after prescribing Homoeopathic Medicine in duration of 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| There will be some improvement after applying Local application in duration of 3 months |
There will be some improvement after applying Local application in duration of 3 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 3 |
|
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
Modification(s)
|
Years="0" Months="9" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Heel fissures, another name for cracked heels, are a common foot ailment that can cause pain or discomfort in addition to being an aesthetic problem. A significant percentage of the population is prone to heel cracks, which are more common in specific populations such as the elderly, people with diabetes, and people whose jobs require standing for extended periods of time. Housewives and maids are especially prone to heel cracks because of a number of distinctive aspects of their work environment and everyday activities: A lot of the time, housewives and maids stand, walk, and work long hours on household duties. Performing household chores like dishwashing, mopping floors, and laundry frequently exposes one to water and cleaning supplies. Detergents and cleaning products can be abrasive to the skin, making it more prone to dryness and irritation. Without protective gear like gloves, prolonged exposure to these chemicals can worsen skin dryness and cause cracked heels. Farmers are also prone to heel cracks, especially if they operate in inadequate footwear or barefoot and routinely do chores that require extended exposure to soil and water. Severe heel cracks can impair mobility and negatively impact day-to-day activities by causing pain, discomfort, and trouble walking. According to the (IJDVL) Indian Journal of Dermatology Venerology and Leprology “Prevalence and correlates of fissure foot in a rural area, the prevalence is found to be more among the females (58.4%) than in males (33.3%) and it is more among the housewives(63.7%), and among the farmers(41.9%).Low weight and non-use of footwear are significantly associated with fissuring,40% of the affected group felt that this is more acute during winter. Classic homeopathic medicine can be used as a holistic natural treatment of heel cracks. Potential advantages of incorporating homeopathic medicine in the conventional dermatology practice include low cost, availability, ease of administration, patient acceptability, and reduction in topical steroid use. Sometimes patient may experience burning and stinging after application of topical agents, such as topical steroids and Particularly in those with sensitive skin or allergies, topical therapies can occasionally result in irritation, allergic reactions, or side effects. Additionally, patients also may see improvements in symptoms caused by seemingly unrelated medical conditions when their cracked heel is treated holistically with homeopathic medicine. External application able to lock moisture into the damaged skin on the cracked heels .this may prevent the skin from drying out and cracking. It can effectively reduce pain and heel crack. Petroleum jelly has been widely used for its moisturizing and protective properties, making it a potential solution for managing heel fissures. This study aims to evaluate the efficacy of petroleum jelly as an external application in the treatment of heel fissures. The research focuses on understanding its role in enhancing skin hydration, forming a protective barrier to prevent moisture loss, promoting healing, and reducing the risk of infections.
RESEARCH QUESTION: Whether the patient suffering from heel cracks will get beneficial result after taking homoeopathic medicines or External application? Hypothesis Null Hypothesis:There is no significant difference in the treatment outcomes of heel cracks between patients treated with external medication and those treated with internal homoeopathic medicines. Alternative Hypothesis: There is a significant difference in the treatment outcomes of heel cracks between patients treated with external medication and those treated with internal homoeopathic medicines. |