| CTRI Number |
CTRI/2025/03/082522 [Registered on: 18/03/2025] Trial Registered Prospectively |
| Last Modified On: |
18/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Use of Kent Repertory in the management of Calcaneal spur |
|
Scientific Title of Study
|
Utility of Repertory of Homoeopathic Materia Medica by Dr James Tyler Kent in selection of Individualized Homoeopathic Medicine for management of Calcaneal spur |
| 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 Richa Chaudhary |
| Designation |
Post Graduate trainee |
| Affiliation |
State National Homoeopathic Medical College and Hospital, Viraj Khand 1, Gomti Nagar, Lucknow |
| Address |
Department of case Taking and Homoeopathic Repertory State National Homoeopathic Medical College and Hospital Viraj Khand 1 Gomti Nagar Lucknow
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
7991809190 |
| Fax |
|
| Email |
rc23nov@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vinay Shankar Tiwari |
| Designation |
Reader |
| Affiliation |
State National Homoeopathic Medical College and Hospital, Viraj Khand 1, Gomti Nagar, Lucknow |
| Address |
Department of Homoeopathic Pharmacy State National Homoeopathic Medical College and Hospital Viraj Khand 1 Gomti Nagar Lucknow
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
9893084182 |
| Fax |
|
| Email |
drvinaytiwariarogya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Richa Chaudhary |
| Designation |
Post Graduate Trainee |
| Affiliation |
State National Homoeopathic Medical College and Hospital, Viraj Khand 1, Gomti Nagar, Lucknow |
| Address |
Department of case Taking and Homoeopathic Repertory State National Homoeopathic Medical College and Hospital Viraj Khand 1 Gomti Nagar Lucknow
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
7991809190 |
| Fax |
|
| Email |
rc23nov@gmail.com |
|
|
Source of Monetary or Material Support
|
| Out Patient Department of State National Homoeopathic Medical College and Hospital Viraj Khand 1 Gomti Nagar Lucknow Uttar Pradesh 226010 |
|
|
Primary Sponsor
|
| Name |
Dr Richa Chaudhary |
| Address |
Department of Case Taking and Homoeopathic Repertory State National Homoeopathic Medical College and hospital Viraj Khand 1 Gomti Nagar Lucknow Uttar Pradesh 226010 |
| Type of Sponsor |
Other [] |
|
|
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 Richa Chaudhary |
State National Homoeopathic Medical College and Hospital Lucknow |
OPD-08 Department of Case Taking and Homoeopathic Repertory State National Homoeopathic Medical College and Hospital Viraj Khand 1 Gomti Nagar Lucknow Uttar Pradesh 226010
Lucknow
UTTAR PRADESH |
7991809190
rc23nov@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of State National Homoeopathic Medical College and Hospital Lucknow |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M773||Calcaneal spur, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized Homoeopathic Medicine using Repertory of Homoeopathic Materia Medica by Dr James Tyler Kent |
Patients qualifying to inclusion criteria will be included in the study. Proper case taking of all enrolled patients will be done in standardized case taking proforma which is being used in State National Homoeopathic medical college and hospital. Homoeopathic medicines will be prescribed to all patients after analysis and evaluation of symptoms and proper repertorization using Repertory of Homoeopathic Materia Medica by Dr James Tyler Kent. Indicated homoeopathic remedy will be administered as decided appropriate to the case or condition in appropriate potency (30CH, 200CH, 1M) and doses. Medicines will be given by oral route. Each case will be followed up at regular interval preferably at a period of 15 days or as per requirement. Patient will be studied for 6 months after enrollment in study. Outcome assessment of the patients will be carried out after 6 months of homoeopathic medication based on Visual Analogue Scale 0-100mm at the end of 6 months. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
.Patient fulfilling the diagnostic criteria of calcaneal spur i.e.x-ray of heel,VAS scale
.patient giving consent to participate.
.patient having no other complicated systemic disease.
.patient presenting with non-traumatic heel pain. |
|
| ExclusionCriteria |
| Details |
.patient presenting with traumatic heel pain.
.cases already taking homoeopathic treatment for any other systemic illness.
.patient who were not willing to come for follow up.
.patients having any serious medical illness.
.pregnant and lactating mothers. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of individualized homoeopathic medicine selected using repertory of homoeopathic materia medica by dr James tyler kent using visual analogue scale before and after treatment. |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The study will determine whether the quality of life of patients suffering from calcaneal spur can be improved by using individualized homoeopathic medicine. |
3 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
23/03/2025 |
| 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
|
Calcaneal spur is a small calcification occuring at the insertion of the planter fascia to the periosteum on the under surface of the calcaneous .It is more common in those who have decreased elasticity of the plantar heel fat pad that occurs in older people,females,overweight or obese,frequently in runners ,aerobic exercise dancers and ballet dancers. At the end of the study,it is expected that homoeopathic medicine selected with the help of kent repertory will prove effective in the management of calcaneal spur.It is also expected that the patient improves symptomatically which is evident through the valid scale ( visual analogue scale) and x-ray of the ankle joint. |