| CTRI Number |
CTRI/2025/09/094277 [Registered on: 04/09/2025] Trial Registered Prospectively |
| Last Modified On: |
03/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To study the effect of homoeopathic medicines in patients with plantar fasciitis. |
|
Scientific Title of Study
|
Exploring the efficacy of individualized homoeopathic medicines in the management of plantar fasciitis in age group of 18 to 60 years |
| 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 Purvi Ashok Patel |
| Designation |
PG Student |
| Affiliation |
PG Scholar Department of Homoeopathic Materia Medica Dr D Y Patil Homoeopathic medical college and research centre |
| Address |
PG Scholar Department of Homoeopathic Materia Medica Dr D Y Patil Homoeopathic medical college and research centre Sant tukaram nagar Pimpri Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
8308861366 |
| Fax |
|
| Email |
2000purvipatel@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Purvi Ashok Patel |
| Designation |
PG Student |
| Affiliation |
PG Scholar Department of Homoeopathic Materia Medica Dr D Y Patil Homoeopathic medical college and research centre |
| Address |
PG Scholar Department of Homoeopathic Materia Medica Dr D Y Patil Homoeopathic medical college and research centre Sant tukaram nagar Pimpri Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
8308861366 |
| Fax |
|
| Email |
2000purvipatel@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Preeti Lamba |
| Designation |
Professor |
| Affiliation |
Professor, Department of Homoeopathic Materia Medica, Dr D Y Patil Homoeopathic medical college and research centre |
| Address |
Department of Homoeopathic Materia Medica, ground floor, Dr D Y Patil Homoeopathic medical college and research centre Sant tukaram nagar Pimpri Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9011076454 |
| Fax |
|
| Email |
preeti.lamba@dpu.edu.in |
|
|
Source of Monetary or Material Support
|
| OPD IPD Complex Department of Homoeopathic Materia Medica Ground Floor Dr D Y Patil Homoeopathic medical college and research centre Sant Tukaram Nagar Pimpri Pune 411018 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 Purvi Ashok Patel |
Dr D Y Patil Homoeopathic medical college and research centre Sant Tukaram Nagar Pimpri Pune India |
OPD IPD Complex 1st Floor Department of Homoeopathic materia medica
Pune
MAHARASHTRA |
08308861366
2000purvipatel@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr D Y Patil Homoeopathic Medical College and Research centre Institutional Ethics Committee |
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 |
Individualized Homoeopathic Medicines |
Dose Centicimal scale
Frequency TDS
Route of administration Oral
Duration 6 months |
| Comparator Agent |
NIL |
NIL as Single Arm Study |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Suspected cases of plantar fasciitis that fulfil the diagnostic criteria and also confirmed by clinical features and clinical examination
Patients having normal view in X ray lateral view of foot
|
|
| ExclusionCriteria |
| Details |
Patient having calcaneal spur
Known case of gout
Diagnosis of fracture in calcaneal region
Open wound in calcaneal region
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To reduce the pain of Plantar Fasciitis |
Baseline Fortnightly till end of 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in Foot Function Index |
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)
|
30/10/2025 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Single arm interventional study This study explores the use of individualized homoeopathic medicines for managing plantar fasciitis in age group of 18 to 60 years To assess the treatment effectiveness Foot Function Index will be used 50 patients of plantar fasciitis that fulfil the diagnostic criteria and also confirmed by clinical features and clinical examination will be enrol in the study |