| CTRI Number |
CTRI/2025/08/093374 [Registered on: 21/08/2025] Trial Registered Prospectively |
| Last Modified On: |
20/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Homoeopathic medicine for adults with sharp or stabbing pain in the heel |
|
Scientific Title of Study
|
Efficacy of individualized homoeopathic medicines in the pain management of plantar fasciitis in adults: A double-blind, randomized, placebo-controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1327-0681 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sudipta Samanta |
| Designation |
Postgraduate Trainee |
| Affiliation |
D.N.De Homoeopathic Medical College and Hospital |
| Address |
Dept. of Practice of Medicine, 12, Gobinda Khatick Road, Tangra, Kolkata 700046, West Bengal
Kolkata
WEST BENGAL
700046
India |
| Phone |
9775316571 |
| Fax |
|
| Email |
samantasudipta72@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sudipta Samanta |
| Designation |
Postgraduate Trainee |
| Affiliation |
D N De Homoeopathic Medical College and Hospital |
| Address |
Dept. of Practice of Medicine, 12, Gobinda Khatick Road, Tangra, Kolkata 700046, West Bengal
Kolkata
WEST BENGAL
700046
India |
| Phone |
9775316571 |
| Fax |
|
| Email |
samantasudipta72@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sumana Sengupta |
| Designation |
Lecturer, Dept. of Practice of Medicine |
| Affiliation |
D N De Homoeopathic Medical College and Hospital |
| Address |
Lecturer, Dept. of Practice of Medicine, 12, Gobinda Khatick Road, Tangra, Kolkata 700046, West Bengal
Kolkata
WEST BENGAL
700046
India |
| Phone |
9748192242 |
| Fax |
|
| Email |
sumanaseng@gmail.com |
|
|
Source of Monetary or Material Support
|
| D.N.De Homoeopathic Medical College and Hospital, 12, Gobinda Khatick Road, Tangra, Kolkata 700046
West Bengal |
|
|
Primary Sponsor
|
| Name |
D.N.De Homoeopathic Medical College and Hospital |
| Address |
12, Gobinda Khatick Road, Tangra, Kolkata 700046
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 |
| Dr Sudipta Samanta |
D N De Homoeopathic Medical College and Hospital |
Dept. of Practice of Medicine, OPD No. 1 and PG 5 OPD, 12, Gobinda Khatick Road, Tangra, Kolkata 700046, West Bengal
Kolkata
WEST BENGAL |
9775316571
samantasudipta72@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of D N De Homoeopathic Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M722||Plantar fascial fibromatosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized homoeopathic medicines and concomitant care |
Intervention is planned as administering indicated homoeopathic medicines in centesimal potencies (CH). Each dose will consist of 3-4 globules (no. 30) of cane sugar, moistened with the indicated medicine (preserved in 90% v/v ethanol), to be taken orally on a clean tongue in an 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 their 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 considering presenting symptom totality, clinical history details, constitutional features, miasmatic expressions, repertorization using HOMPATH/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.
• Concomitant care (CC): Distribution of the post-intervention variable will be checked between groups. All the enrolled patients will receive advices on general management which includes ice cube massage over the painful foot, wear cushioned shoe, calf stretches and plantar fascia-specific stretches ( towel stretch, wall stretch), tennis ball or frozen water bottle for rolling, the use of an orthosis (heel pads, heel cups, arch supports, or night splints), Stretching of the gastrocnemius muscle is a main stay of treatment of PF. Also patients will be advised to take food rich in vitamin C, vitamin D, vitamin E and calcium. All the dietary recommendation will be customised according to the socio-economic and cultural background of the participants and as instructed by the dietician.
Duration of therapy - 3 months. |
| Comparator Agent |
placebo and Concomitant care |
This arm will receive a placebo plus standard care. The placebo is identical in appearance to the verum. Each dose of placebo will consist of 3-4 globules (no. 30) of cane sugar, moistened with rectified spirit, to be taken orally on a clean tongue with an empty stomach; dosage and repetition depend upon the individual requirement of the cases.
Concomitant care (CC): Distribution of the post-intervention variable will be checked between groups. All the enrolled patients will receive advices on general management which includes ice cube massage over the painful foot, wear cushioned shoe, calf stretches and plantar fascia-specific stretches ( towel stretch, wall stretch), tennis ball or frozen water bottle for rolling, the use of an orthosis (heel pads, heel cups, arch supports, or night splints), Stretching of the gastrocnemius muscle is a main stay of treatment of PF. Also patients will be advised to take food rich in vitamin C, vitamin D, vitamin E and calcium. All the dietary recommendation will be customised according to the socio-economic and cultural background of the participants and as instructed by the dietician.
Duration of therapy: 3 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Cases suffering from PF for a minimum of 12 weeks
2. Had not taken any form of treatment for the past 2 weeks
3. Age between 18 and 65 years.
4. Participants of either sex or transgender. |
|
| ExclusionCriteria |
| Details |
1. Patient denying consent to participate in the trial.
2. Vulnerable population – unconscious, non-ambulatory, too sick for consultation; differently abled; or terminally or critically ill subjects
3. Suffering from calcaneal spur or any bony deformity or foot pathology (ex. Flat foot)
4. Elevated serum uric acid level.
5. Diagnosed cases of unstable mental or psychiatric illness or other uncontrolled or life-threatening illness affecting quality of life or any organ failure
6. Pregnant and puerperal women, lactating mothers
7. Tobacco chewing and/or smoking, alcoholism, and/or any other form(s) of substance abuse and/or dependence
8. Undergoing homeopathic treatment for any chronic disease(s) within last 6 months
9. Simultaneous participation in any other clinical trials |
|
|
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 |
| Foot Function Index (FFI) |
At baseline, monthly up to 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| McGill Pain Questionnaire 1.0 (SF-MPQ) |
At baseline, monthly up to 3 months |
| Measure Yourself Medical Outcome Profile version 2 (MYMOP-2) |
At baseline, monthly up to 3 months |
|
|
Target Sample Size
|
Total Sample Size="106"
Sample Size from India="106"
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)
|
01/09/2025 |
| 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) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
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 - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [samantasudipta72@gmail.com].
- For how long will this data be available start date provided 01-01-2028 and end date provided 31-12-2032?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Plantar fasciitis (PF) is a chronic degenerative condition causing marked thickening and fibrosis of the plantar fascia, and collagen necrosis, chondroid metaplasia, and calcification. Microtears at the calcaneal origin of the plantar fascia, provoking an inflammatory response thought to be produced by repetitive traction of the plantar fascia during walking or running [2]. Patients usually complain of pain at the anteromedial prominence of the calcaneum. The pain is exacerbated by passive dorsiflexion of the toes. Symptoms may have been present for weeks or months at the time of presentation. The pain is worse when first standing after rest, typically early in the morning. Once the patient starts walking, the pain tends to recede. Obesity and reduced ankle dorsiflexion are recognized risk factors for the condition. Under such circumstances, we intend to undertake this research project to evaluate the efficacy and safety of IHMs in the pain management of patients with plantar fasciitis in adults. A double-blind, randomized (2:1), placebo-controlled trial will be conducted on 106 adults who are suffering from plantar fasciitis at the outpatient department of D. N. De Homoeopathic Medical College and Hospital. Assessment will be done by Foot Function Index (FFI) [primary outcomes], MYMOP-2 (Measure Yourself Medical Outcome Profile) [secondary outcomes], and Short-Form McGill Pain Questionnaire 1.0 (SF-MPQ) every month up to 3 months. Comparative analysis will be carried out to detect group differences. |