| CTRI Number |
CTRI/2024/04/065561 [Registered on: 12/04/2024] Trial Registered Prospectively |
| Last Modified On: |
06/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A study to assess the role of indicated Homoeopathic medicines for management of pain in the cases of Calcaneal Spur |
|
Scientific Title of Study
|
A Randomized Placebo Controlled Trial to assess the efficacy of indicated Homoeopathic medicines for management of pain in the cases 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 Tanya Vaish |
| Designation |
PG Scholar |
| Affiliation |
Dr M P K Homoeopathic Medical College Hospital And Research Centre |
| Address |
Department Of Materia Medica Dr M P K Homoeopathic Medical College Hospital And Research Centre A Constituent College Of Homoeopathy University Saipura Sanganer Jaipur Rajasthan
Jaipur
RAJASTHAN
302029
India |
| Phone |
9935015887 |
| Fax |
|
| Email |
dr.tanyavaish25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vanija Sharma |
| Designation |
Head Of The Department Of Materia Medica |
| Affiliation |
Dr M P K Homoeopathic Medical College Hospital And Research Centre |
| Address |
Department Of Materia Medica Dr M P K Homoeopathic
Medical College Hospital And Research Centre A Constituent College Of Homoeopathy University Saipura Sanganer Jaipur Rajasthan
Jaipur
RAJASTHAN
302029
India |
| Phone |
9680438770 |
| Fax |
|
| Email |
drvanijasharma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tanya Vaish |
| Designation |
PG Scholar |
| Affiliation |
Dr M P K Homoeopathic Medical College Hospital And Research Centre |
| Address |
Department Of Materia Medica Dr M P K Homoeopathic Medical College Hospital And Research Centre A Constituent College Of Homoeopathy University Saipura Sanganer Jaipur Rajasthan
Jaipur
RAJASTHAN
302029
India |
| Phone |
9935015887 |
| Fax |
|
| Email |
dr.tanyavaish25@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of Materia Medica Dr Girendra Pal Homoeopathic Hospital And Research Centre Collegiate Hospital Of Dr M P K Homoeopathic
Medical College Hospital And Research Centre A
Constituent College Of Homoeopathy University
Saipura Sanganer Jaipur Rajasthan 302029 |
|
|
Primary Sponsor
|
| Name |
Dr M P K Homoeopathic Medical College Hospital And Research Centre |
| Address |
10 11 12 Ward No 36 Saipura Sanganer Jaipur Rajasthan |
| 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 |
| Dr Tanya Vaish |
Dr Girendra Pal Homoeopathic Hospital And Research Centre |
Department Of Materia Medica OPD Room No 4 Dr M P K Homoeopathic Medical College Hospital And Research Centre A
Constituent College Of Homoeopathy University 10 11 12 Ward No 36 Saipura Sanganer Jaipur Rajasthan 302029
Jaipur
RAJASTHAN |
9935015887
dr.tanyavaish25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Homoeopathy University Jaipur |
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 |
Indicated Homoeopathic Medicines |
According To The Requirement Of Patients Susceptibility And Homoeopathic Principles Homoeopathic Medicine Shall Be Given Orally Potency 6C And 30C Will Be Given In 2 Globlues Size 40 Dosage And Repetition TDS Per Day And If Higher Potency Will Be Given In 200C And Above Then A Single Dose 4 globules Of It Shall Be Followed By Placebo 2 Globules Dosage And Repetition TDS Per Day Reassessment At The End Of 3 Months |
| Comparator Agent |
Placebo |
Oral Administration Of Placebo In Form Globules Size 40 Dosage And Repetition TDS Reassessment At The End Of 3 Months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
79.00 Year(s) |
| Gender |
Both |
| Details |
1 Previously diagnosed cases of Calcaneal spur seeking Homoeopathic treatment
2 Newly diagnosed cases of Calcaneal spur on basis of radiological finding that is X ray foot lateral view
3 ICD-10 code M7730 Calcaneal spur
4 Patient with clinical Sign and symptoms Minimum 3 of the following must be present to enrolling study Pain and tenderness over ball of the heel causes difficulty in walking Slight swelling morning aggravation in pain stitching type of pain Pain usually increases after long walks and routine activities, especially at night or after work while resting |
|
| ExclusionCriteria |
| Details |
1 Patient not giving consent
2 Female who are pregnant or lactating
3 Cases which require any emergency treatment
4 History of previous ankle or heel fracture or surgery Patient with any neurological, autoimmune diseases and systemic diseases with any complication, which requires other mode of treatment
5 Patient pursuing other treatment and not willing to leave it
6 Immuno compromised patient such as suffering from HIV, Hepatitis B or C etc |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
According to the scores obtained (pre and post
treatment) from the Numeric Rating Scale (NRS) |
Pre score will be taken at baseline of treatment
and post score will assessed at the end of 12
weeks using Numeric Rating Scale |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the role of indicated Homoeopathic medicines for management of pain in the cases of Calcaneal Spur |
12 Months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
17/04/2024 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Aim- To assess the efficacy of indicated homoeopathic medicines for management of pain in the cases of Calcaneal spur Objective- To assess the efficacy of indicated homoeopathic medicines for management of pain in the cases of Calcaneal spur through analysis of pre and post treatment NRS scores |