| CTRI Number |
CTRI/2026/02/104872 [Registered on: 26/02/2026] Trial Registered Prospectively |
| Last Modified On: |
25/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of Homeopathy Medicine in Heel and Foot Pain |
|
Scientific Title of Study
|
Assessing the Role of Constitutional Medicine in the Management of Plantar Fasciitis by using Plantar Fasciitis Pain, Disability Scale In 40 To 60 Years Of Age Group |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NOT APPLICABLE |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aishwarya Kulkarni |
| Designation |
PG Scholar |
| Affiliation |
Bharatesha Homoeopathic Medical College & Hospital |
| Address |
OPD No 02 and IPD Department of Organon of Medicine and Homoeopathic Philosophy Bharatesh Homoeopathic Medical College & Hospital Sy No 16 Basavan Kudachi Extension Shindoli Road Belagavi
Belgaum KARNATAKA 591124 India |
| Phone |
8971529300 |
| Fax |
|
| Email |
dr.aishwaryamkulkarni@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Lingaraj B Magadum |
| Designation |
Professor |
| Affiliation |
Bharatesha Homoeopathic Medical College & Hospital |
| Address |
OPD No 02 and IPD Department of Organon of Medicine and Homoeopathic Philosophy Bharatesh Homoeopathic Medical College & Hospital Sy No 16 Basavan Kudachi Extension Shindoli Road Belagavi
Belgaum KARNATAKA 591124 India |
| Phone |
9901591449 |
| Fax |
|
| Email |
dr.lingarajmagadum@bhmc.edu.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Lingaraj B Magadum |
| Designation |
Professor |
| Affiliation |
Bharatesha Homoeopathic Medical College & Hospital |
| Address |
OPD No 02 and IPD Department of Organon of Medicine and Homoeopathic Philosophy Bharatesh Homoeopathic Medical College & Hospital Sy No 16 Basavan Kudachi Extension Shindoli Road Belagavi
Belgaum KARNATAKA 591124 India |
| Phone |
9901591449 |
| Fax |
|
| Email |
dr.lingarajmagadum@bhmc.edu.in |
|
|
Source of Monetary or Material Support
|
| Bharatesh Homoeopathic Medical College & Hospital Sy No 16 Basavan Kudachi Extension Shindoli Road Belagavi - 591124 |
|
|
Primary Sponsor
|
| Name |
Dr. Aishwarya Kulkarni |
| Address |
OPD No 02 and IPD Department of Organon of Medicine and Homoeopathic Philosophy Bharatesh Homoeopathic Medical College & Hospital Sy No 16 Basavan Kudachi Extension Shindoli Road Belagavi - 591124 |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Not Applicable |
Not Applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Aishwarya Kulkarni |
Bharatesh Homoeopathic Medical College & Hospital |
OPD No 02 and IPD Department of Organon of Medicine and Homoeopathic Philosophy Bharatesh Homoeopathic Medical College & Hospital Sy No 16 Basavan Kudachi Extension Shindoli Road Belagavi - 591124 Belgaum KARNATAKA |
8971529300
dr.aishwaryamkulkarni@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee BETs Bharatesh Homeopathic Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M722||Plantar fascial fibromatosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Constitutional Medicine |
Constitutional Medicine will be administerd based on the study subject Constitution suffering from Plantar Fasciitis orally for the duration of once in 15 days for 2 months and later monthly for 4 months. |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Subjects of either genders, irrespective of occupation and socio - economic status.
Subjects willing to give written consent.
Subjects with clinically diagnosed cases of Plantar Fasciitis. |
|
| ExclusionCriteria |
| Details |
Subjects suffering from acute uncontrolled systemic illness like Diabetes mellitus, Hypertension etc. Self-reported immunocompromised state like AIDS and All case of psychiatric illness.
History of systemic diseases that could contribute to heel pain like diabetes mellitus (especially with neuropathy), Rheumatoid arthritis or other inflammatory arthropathies, Gout, Seronegative spondyloarthropathies.
Unwilling to take part and not giving consent to join the study.
Subjects on hormonal treatment, pregnant women, and lactating mother.
Subjects with trauma or injury to the heel in the last 6 months.
Subjects who are under surgical treatments or steroid injection for Plantar Fasciitis in the last 6 months.
Subjects who are having flat feet (pea planus) or high -arched feet deformities. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Recovered
No recurrence of the complaints and symptoms during study period with general wellbeing of the subjects and changes in Plantar Fasciitis pain and disability scale (PFPS) with greater or equal to 75% reduction will be considered Recovered
Improved
Decrease in the intensity of the symptoms without complete recovery. PFPS with 30% to 74.99% reduction will be Improved.
Not improved
Those with less than 30% reduction or worsening or dropped out cases will be categorized as not Improved. |
once in 15 days for 2 months and later monthly for 4 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not Applicable |
Not Applicable |
|
|
Target Sample Size
|
Total Sample Size="39" Sample Size from India="39"
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)
|
31/03/2026 |
| 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="2" Months="0" 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
|
Plantar Fasciitis is a prevalent and disabling musculoskeletal condition, affecting approximately 4% to 7% of the population at any given time. This figure is notably higher among individuals who engage in occupations or activities that require prolonged standing, walking, or running, such as healthcare workers, teachers, athletes, and factory employees. Despite its seemingly localized presentation, Plantar Fasciitis has far-reaching consequences on an individual’s quality of life, including physical discomfort, 5 psychological stress, emotional distress, and socioeconomic burden due to reduced productivity and absenteeism.10 • The condition is characterized by chronic heel pain, particularly severe during the first steps after rest or prolonged standing, and may persist for months or even years if not addressed appropriately. Over time, the constant pain can lead to functional limitations, altered gait, compensatory injuries, and mental fatigue, underscoring the necessity for a treatment approach that not only addresses symptoms but also targets the underlying constitutional susceptibilities of the individual. • Constitutional Homoeopathy offers a distinct and holistic treatment modality, rooted in the principle of individualization. This system of medicine aims to stimulate the body’s innate healing capacity by selecting a remedy that corresponds most closely to the patient’s totality of symptoms – physical, mental, and emotional. Rather than suppressing symptoms, constitutional treatment seeks to restore balance at a systemic level, thereby addressing the root cause and preventing recurrence. • Despite the increasing use of homoeopathy globally, there exists a notable paucity of systematic clinical research focusing on its efficacy in musculoskeletal disorders, particularly in Plantar Fasciitis. Existing literature has predominantly concentrated on mechanical interventions, physiotherapy, or pharmacological modalities, often overlooking the potential benefits of individualized homoeopathic treatment. In this context, my study seeks to bridge this gap by exploring the role of constitutional homoeopathic remedies in the management of Plantar Fasciitis using validated outcome tools such as the Plantar Fasciitis Pain Scale (PFPS). • The present study is undertaken with the intent to evaluate the scope of constitutional homoeopathic treatment in managing Plantar Fasciitis through individualized case analysis and outcome assessment. By employing the PFPS scale, it becomes possible to systematically measure changes in pain intensity and disability, thereby ensuring a structured and objective approach to clinical evaluation. 6 • This research aims to offer evidence on the therapeutic potential of constitutional remedies in reducing pain, improving mobility, and enhancing the overall quality of life in patients suffering from Plantar Fasciitis. The findings may provide a foundation for more extensive clinical trials in the future and help promote the integration of homoeopathy as a safe, cost-effective, and patient-centric approach to chronic musculoskeletal conditions. |