| CTRI Number |
CTRI/2022/09/045249 [Registered on: 06/09/2022] Trial Registered Prospectively |
| Last Modified On: |
22/08/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Homeopathy
Diagnostic
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Heel pain in adults and its homoeopathic treatment |
|
Scientific Title of Study
|
Effectiveness of individualized homoeopathic medicines in pain control and improvement of quality of life in adults with calcaneodynia-A single group of pre-post interventional study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nagasaram Nagaraju |
| Designation |
post graduate trainee |
| Affiliation |
Mahesh Bhattacharyya Homoeopathic Medical College and Hospital |
| Address |
Department of Homoeopathic Materia Medica, Mahesh Bhattacharyya Homoeopathic Medical College and Hospital, Dr B.N.Chakraborty sarani, Dumurjola, Howrah-711104
Haora
WEST BENGAL
711104
India |
| Phone |
8919479900 |
| Fax |
|
| Email |
nagasaramnagaraju@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mihir kanti biswas |
| Designation |
Professor |
| Affiliation |
Mahesh Bhattacharyya Homoeopathic Medical College and Hospital |
| Address |
Department of Homoeopathic Materia Medica, Mahesh Bhattacharyya Homoeopathic Medical College and Hospital, Dr B.N.Chakraborty sarani, Dumurjola, Howrah-711104
Haora
WEST BENGAL
711104
India |
| Phone |
9051236301 |
| Fax |
|
| Email |
drmkb33@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mihir kanti biswas |
| Designation |
Professor |
| Affiliation |
Mahesh Bhattacharyya Homoeopathic Medical College and Hospital |
| Address |
Department of Homoeopathic Materia Medica, Mahesh Bhattacharyya Homoeopathic Medical College and Hospital, Dr B.N.Chakraborty sarani, Dumurjola, Howrah-711104
Haora
WEST BENGAL
711104
India |
| Phone |
9051236301 |
| Fax |
|
| Email |
drmkb33@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Homoeopathic Materia Medica, Mahesh Bhattacharyya Homoeopathic Medical College and Hospital, Dr B.N.Chakraborty sarani, Dumurjola, Howrah-711104 |
|
|
Primary Sponsor
|
| Name |
Dr Nagasaram Nagaraju |
| Address |
Department of Homoeopathic Materia Medica, Mahesh Bhattacharyya Homoeopathic Medical College and Hospital, Dr B.N.Chakraborty sarani, Dumurjola, Howrah-711104 |
| Type of Sponsor |
Other [self] |
|
|
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 Nagasaram Nagaraju |
Mahesh Bhattacharyya Homoeopathic Medical College and Hospital |
out patients of Materia medica department, room no 11 of hospital
Haora
WEST BENGAL |
8919479900
nagasaramnagaraju@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M773||Calcaneal spur, (2) ICD-10 Condition: M766||Achilles tendinitis, (3) ICD-10 Condition: M722||Plantar fascial fibromatosis, (4) ICD-10 Condition: M939||Osteochondropathy, unspecified, (5) ICD-10 Condition: M708||Other soft tissue disorders related to use, overuse and pressure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized Homoeopathic Medicine |
Homoeopathic Medicines will be selected based on the presenting complaints and totality of symptoms. The medicine will be prescribed in 30 centesimal potencies one dose for 14 days. All the medicines have been thoroughly proven and the details are written in Materia Medica Pura. the duration of intervention is 18 months. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Cases suffering from heel pain due to overuse, heavy strain and pressure.
2. Patients willing to do laboratory investigations when required for study.
3. Patients willing to participate and comply with the study procedure. |
|
| ExclusionCriteria |
| Details |
1. Cases too sick for consultation.
2. Patients unwilling to take part or not giving consent to join the study.
3. Cases suffering from some congenital bony deformities or foot pathology.
4. Patients requiring surgical interventions and orthopedic corrections.
5. Diagnosed cases of uncontrolled systemic diseases, unstable mental or psychiatric
illness or other uncontrolled or life-threatening illness affecting quality of life or any
organ failure.
6. Undergoing homoeopathic treatment for chronic disease within last 6 months.
7. Self-reported immune-compromised state.
8. Substance abuse and/or dependence.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The foot functional index is the scale that is used to assess the severity of pain. |
Baseline and at each follow up at an interval of 4 weeks for 3 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment of quality of life using SF-36 questionnaire. |
Baseline and at each follow up at an interval of 4 weeks for 3 months. |
|
|
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)
|
13/10/2022 |
| 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
|
Non yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [nagasaramnagaraju@gmail.com].
- For how long will this data be available start date provided 01-01-2024 and end date provided 01-06-2027?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Heel pain refers to any pain or discomfort felt in or around the back of the foot. A variety of soft tissues, osseous, and systemic disorders can cause heel pain, but the mechanical cause tops it all among the others which usually develops as a result of constant strain on the heel. it is estimated that roughly 10% of the general population is affected, with 83 percent of those affected being active working individuals between the age of 18 to 65. there are very few clinical studies are done on plantar fasciitis and calcanean spur, but no works are done on other causes of heel pain in related to homoeopathy management in heel pain and improvement of quality of life. so, this study is undertaken to justify the following question and hypothesis.
Research question: Does individualized homoeopathic medicines has a role in the treatment of pain control and improvement of quality of life of calcaneodynia in adults?
Hypothesis:
Null hypothesis: there is no significant role of individualized homoeopathic medicines in the control of pain and improvement of quality of life of calcaneodynia in adults
Alternative hypothesis: Individualized homoeopathic medicines have a significant role in control of pain and improvement of quality of life of calcaneodynia in adults |