| CTRI Number |
CTRI/2024/12/077610 [Registered on: 03/12/2024] Trial Registered Prospectively |
| Last Modified On: |
29/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect Of Homoeopathic Medicines In The Management Of Calcaneal Spur |
|
Scientific Title of Study
|
Assessing The Effectiveness Of Individualised Homoeopathic Medicines In The Management Of Calcaneal Spur Using Homoeopathic Medical Repertory By Robin Murphy A Prospective Single Arm Pre Post Comparison Clinical 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 Vibhor Bhartiya |
| Designation |
PG Scholar |
| Affiliation |
Bakson Homoeopathic Medical College And Hospital |
| Address |
Department Of Case Taking And Repertory
Basement
Room no B 15
Bakson Homoeopathic Medical College And Hospital
36 B
Phase 1
Knowledge Park 1
Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9910511046 |
| Fax |
|
| Email |
vibhorbhartiya1996@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shailja Upadhyay |
| Designation |
Guide and Associate professor |
| Affiliation |
Bakson Homoeopathic Medical College And Hospital |
| Address |
Bakson Homoeopathic Medical College And Hospital
36 B
Phase 1
Knowledge Park 1
Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
8447753501 |
| Fax |
|
| Email |
drshailjaupadhyay22@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashwini Nair |
| Designation |
PG Incharge |
| Affiliation |
Bakson Homoeopathic Medical College And Hospital |
| Address |
Department Of Homoeopathic Materia Medica
Second Floor
Room no S 1
Bakson Homoeopathic Medical College And Hospital
36 B
Phase 1
Knowledge Park 1
Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9990178024 |
| Fax |
|
| Email |
pginchargebakson@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bakson Homoeopathic Medical College And Hospital
Bakson Homoeopathic Medical College And Hospital
36 B
Phase 1
Knowledge Park 1
Greater Noida
201310
Uttar Pradesh |
|
|
Primary Sponsor
|
| Name |
Bakson Homoeopathic Medical College And Hospital |
| Address |
Principal Office
Ground Floor
Room number G 22
Bakson Homoeopathic Medical College And Hospital
36 B
Phase 1
Knowledge Park 1
Greater Noida
201310
Uttar Pradesh |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vibhor Bhartiya |
Bakson Homoeopathic Medical College And Hospital |
Out patient department (OPD)
Ground floor
Room number 1
Bakson Homoeopathic Medical College And Hospital
36 B
Phase 1
Knowledge park 1
Greater noida 201310
Gautam Buddha Nagar
UTTAR PRADESH |
9910511046
vibhorbhartiya1996@gmail.com |
| Dr Vibhor Bhartiya |
Dr DP Rastogi Central Research Institute Of Homoeopathy |
Out patient department (OPD)
Ground floor
A1/1
Room number 110
Sector 24
Noida
201301
Gautam Buddha Nagar
UTTAR PRADESH |
9910511046
vibhorbhartiya1996@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Bakson Homoeopathic Medical College and Hospital |
Approved |
| Kendriya Homoeopathy Anusandhan Parishad |
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 |
Homoeopathic medicine |
Oral route of administration
Pill form
30 pill size
oral route of administration
centesimal scale
first dose at the time of case taking
subsequent doses according to the follow up
follow up for 6 months |
| Comparator Agent |
Nil |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
64.00 Year(s) |
| Gender |
Both |
| Details |
Participants suffering from calcaneal spur
Participants aged between 25-64 irrespective of their sex socio economic status and occupation
Participants with radiological evidence X ray indicating calcaneal spur
Participants giving written consent to participate in the study
|
|
| ExclusionCriteria |
| Details |
Participants suffering from uncontrolled systemic illnesses (metabolic neurological immunocompromised) or substance abuse
Participants with any other osteo-porotic or bone disease
Participants with tenosynovitis or bursitis
Pregnant and lactating women
Participants with psychiatric diseases
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the changes in scores of pain disability and activity limitation of foot using foot function index (FFI) in cases of calcaneal spur |
15 months study
6 months enrolment
6 months follow up
3 months data analysis and report writing
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To obtain a group of homoeopathic medicines most useful in cases of calcaneal spur |
15 months study
6 months enrolment
6 months follow up
3 months data analysis & report writing |
|
|
Target Sample Size
|
Total Sample Size="31"
Sample Size from India="31"
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)
|
12/12/2024 |
| 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="3"
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
|
This study is to assess the role of Homoeopathic Medicines in the management of calcaneal spur .Total Sample size 31 15 month study
Participants having calcaneal spur will be assessed on the basis of intensity of pain, disability in performing daily activities and limitations in the movement of foot. Assessment will be done by applying foot function index at baseline, after 3rd months and at 6th month. |