| CTRI Number |
CTRI/2022/07/044299 [Registered on: 25/07/2022] Trial Registered Prospectively |
| Last Modified On: |
16/07/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Pain management in case of heel pain by Homoeopathic medicines. |
|
Scientific Title of Study
|
Efficacy of Individualized Homoeopathic Medicines in the Pain Management of Calcaneal spur: A Double-blind, Randomized Placebo-controlled Clinical Trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pratima Pramanik |
| Designation |
Post graduate trainee |
| Affiliation |
The Calcutta Homoeopathic Medical College and Hospital |
| Address |
Department of practice of Medicine; OPD Room no 14; 265-266, Acharya Prafulla Chandra Road, Kolkata
Kolkata
WEST BENGAL
700009
India |
| Phone |
9748199750 |
| Fax |
|
| Email |
pratima.pramanik1920@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Veena Prakash Bharti |
| Designation |
Lecturer |
| Affiliation |
The Calcutta Homoeopathic Medical College and Hospital |
| Address |
Department of Practice of Medicine; OPD Room no 14; 265-266, Acharya Prafulla Chandra Road, Kolkata
Kolkata
WEST BENGAL
700009
India |
| Phone |
9231692840 |
| Fax |
|
| Email |
drvpbharti@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Veena Prakash Bharti |
| Designation |
Lecturer |
| Affiliation |
The Calcutta Homoeopathic Medical College and Hospital |
| Address |
Department of Practice of Medicine; OPD Room no 14; 265-266, Acharya Prafulla Chandra Road, Kolkata
Kolkata
WEST BENGAL
700009
India |
| Phone |
9231692840 |
| Fax |
|
| Email |
drvpbharti@gmail.com |
|
|
Source of Monetary or Material Support
|
| The Calcutta Homoeopathic Medical College and Hospital,265-266, Acharya Prafulla Chandra Road, Kolkata 700009, West Bengal. |
|
|
Primary Sponsor
|
| Name |
The Calcutta Homoeopathic Medical College and Hospital |
| Address |
265-266, Acharya Prafulla Chandra Road, Kolkata 700009, West Bengal |
| Type of Sponsor |
Government 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 |
| Pratima Pramanik |
The Calcutta Homoeopathic Medical College and Hospital |
Department of Practice of Medicine OPD Room no-14 265-266, Acharya Prafulla Chandra Road
Kolkata
WEST BENGAL |
9748199750
pratima.pramanik1920@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Calcutta Homoeopathic Medical College and Hospital Institutional Ethical Committee |
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 |
| Comparator Agent |
Identical-looking placebos |
This group will receive
indistinguishable placebos
along with advices on general
management (if any). Each
dose will consist of 4 cane
sugar globules no. 10
moistened with 90% v/v ethanol, to be taken orally on clean tongue in empty stomach;
dosage and repetition were
maintained depending upon the
individual requirement of the
cases. All sundry items will be procured from a GMP certified firm. Concomitant care: All the enrolled patients will receive advices on general managements i.e., contrast bath, foot exercises plus use of shoes made of microcellular rubber along with psychological counselling to reduce anxiety of patient. Duration of therapy: 6
months.
|
| Intervention |
Individualized homoeopathic medicines in centesimal potencies |
Each dose will consist of 4 cane sugar globules no. 10
moistened with the indicated
medicine (preserved in 90% v/v
ethanol), to be taken orally on clean tongue with empty
stomach; dosage and repetition
depending upon the individual
requirement of the cases.
Patients will be advised to
refrain from handling the
globules or from eating,
drinking, smoking or brushing
teeth within 30 minutes of taking the globules and will be asked to suck the globules rather than simply swallowing those. Single individualized medicine will be prescribed on each occasion taking into account presenting symptom totality, clinical history
details, constitutional features, miasmatic expressions,
repertorization using RADAR
software when required with
due consultation of Materia
Medica and due consensus
among three homoeopaths. All
the medicines and sundry items
will be procured from a Good
Manufacturing Practice (GMP) -
certified firm. Along with the
medicines, the intervention arm will receive advices on general management. Concomitant care: All the enrolled patients will receive advices on general managements i.e., contrast bath, foot exercises plus use of shoes made of microcellular rubber. Duration of therapy 6 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Cases suffering from calcaneal spur (ICD 10 code M77.30)
2. Chronic nature of the condition in question (atleast 6 months of symptom manifestation).
3. Subject must be symptomatic at screening and willing to maintain same environment throughout the study.
4. Literate patient: ability to read Bengali and/ or, English and capability and willingness to give inform consent to comply with the study procedure.
5. Confirmed Radiological diagnosis of Calcaneal spur. |
|
| ExclusionCriteria |
| Details |
1. Cases too sick for consultation.
2. Patient unwilling to take part or not giving consent to join the study.
3. 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.
4. Undergoing any kind of treatment for chronic disease within last 3 months.
5. Self-reported immune compromised state.
6. Substance abuse and/or dependence.
7. Pregnant and lactating women.
8. Taking medications with analgesic or anti-inflammatory effects. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Visual analog scale (VAS) for pain. |
At baseline, after 3 months and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Lower Extremity Functional scale (LEFS) for measurement of lower extremity function and quality of life. |
At baseline, after 3 months and 6 months. |
|
|
Target Sample Size
|
Total Sample Size="128"
Sample Size from India="128"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/09/2022 |
| 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
|
None yet; to be published later. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A calcaneal spur, or commonly known as a heel spur, occurs when bony outgrowth forms on the heel bone. Calcaneal spur can be located at the back of the heel (Dorsal heel spur) or under the sole (Plantar heel spur). The Dorsal spur are usually associated with Achilles tendinopathy while spurs which are present under the sole are associated with Plantar fascitis. Frequency of calcaneal spurs rose with age in patients of Osteoarthritis and Rheumatoid arthritis. Prevalence is 16.3% and 6.5% for males and females respectively, though more frequent in females. The conservative treatment includes Non- steroidal anti-inflammatory drugs, Cortisone injection, Endoscopic plantar fasciotomy, In-step fasciotomy, Extracorporeal Shock Wave Therapy. In this double-blind, randomized, placebo-controlled trial at The Calcutta Homoeopathic Medical College and Hospital, 128 patients suffering from Calcaneal spur will be randomized to either individualized homoeopathic medicines (verum; n=64) or identical-looking placebo (control; n=64). We aim to investigate whether there are any differences in outcomes between these two groups over 6 months of intervention. Visual Analog Scale (VAS) for pain measurement and Lower Extremity Functional Scale (LEFS) for the measurement of lower extremity function and quality of life will be used as the primary and secondary outcome measures respectively. Comparative analysis will be carried out to examine group differences, if any. Results will be published in scientific journals. |