| CTRI Number |
CTRI/2024/01/061534 [Registered on: 16/01/2024] Trial Registered Prospectively |
| Last Modified On: |
07/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Homoeopathy in heel pain for plantar fasciitis |
|
Scientific Title of Study
|
A Prospective Open Label Clinical Trial to evaluate the response of Homoeopathic intervention in plantar fascitis including calcaneal spur |
| Trial Acronym |
PF |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Suraia Parveen |
| Designation |
Research officer (H)/S-3, |
| Affiliation |
Dr. Anjali Chatterji Regional Research Institute for Homoeopathy |
| Address |
Dr. Anjali Chatterji Regional Research Institute for Homoeopathy
50, Rajendra Chatterjee road
Kolkata
WEST BENGAL
700035
India |
| Phone |
7001510319 |
| Fax |
|
| Email |
drsuraiya2009@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suraia Parveen |
| Designation |
Research officer (H)/S-3, |
| Affiliation |
Dr. Anjali Chatterji Regional Research Institute for Homoeopathy |
| Address |
Dr. Anjali Chatterji Regional Research Institute for Homoeopathy
50, Rajendra Chatterjee road
Kolkata
WEST BENGAL
700035
India |
| Phone |
7001510319 |
| Fax |
|
| Email |
drsuraiya2009@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suraia Parveen |
| Designation |
Research officer (H)/S-3, |
| Affiliation |
Dr. Anjali Chatterji Regional Research Institute for Homoeopathy |
| Address |
Dr. Anjali Chatterji Regional Research Institute for Homoeopathy
50, Rajendra Chatterjee road
Kolkata
WEST BENGAL
700035
India |
| Phone |
7001510319 |
| Fax |
|
| Email |
drsuraiya2009@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central council for research in Homoeopathy, NEW DELHI |
|
|
Primary Sponsor
|
| Name |
Central council for research in Homoeopathy |
| Address |
61-65, Institutional area, Janakpuri, New Delhi-110058 |
| Type of Sponsor |
Research institution |
|
|
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 Suraia Parveen |
Dr. Anjali Chatterji Regional Research Institute |
Room no 4
Department Homoeopathy Division Clinical research,
50, Rajendra Chatterji Road
Kolkata-700035
Kolkata
WEST BENGAL |
7001510319
drsuraiya2009@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE DACRRI KOLKATA |
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 |
Homoeopathic medicines |
Homoeopathic medicines in centesimal potencies shall be used in the trial. The selection of the medicine will be based upon totality of symptoms after thorough case taking of the patient in the given Case Recording Format. Investigators at the study centers will be free to prescribe the selected medicine in the potency deemed appropriate by them. The dose of the medicine will be given as per requirement of the patient. Each dose of indicated medicine shall consist of 4 globules (size no. 30). The homoeopathic medicines for the trial shall be procured from any of the licensed firm by the Council. Same batch of medicine shall be used throughout the trial. Intervention medicines will be administered orally. The medicine will be repeated depending on the potency and complaints of the patient in accordance with the principles of Homoeopathy. Once the improvement sets in, placebo is to be continued till the medicine continues to act. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients aged 18 to 65 years
2. Patients of both sexes
3. Diagnosed case of heel pain with plantar fascitis may be unilateral or bilateral
4. Pain in heel (unilateral or bilateral ) in the morning after waking up or first few steps after sitting down or rest for a long time,
5. Local pain and tenderness where the plantar fascia attaches to the heel,
6. Increasing pain in heel with extended walking or standing for more than 15 min.
7. Written Informed consent from the patient.
8. Wash-out period of at least two weeks for any ongoing conventional medicines.
|
|
| ExclusionCriteria |
| Details |
1. Subjects with diagnosed cases of advanced stage of Metabolic disorders like advanced-stage of Diabetes, CKD, and Cardiovascular diseases.
2. Subjects with Focal neurological diseases.
3. Subjects with impaired lower limb circulation.
4. Subjects with infectious diseases of the lower limb.
5. Subjects with congenital deformities of foot and ankle.
6. Subjects who are on other medications.
Pregnant and lactating mother.
7. Subjects not willing to participate in the study.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| To evaluate the outcome of homoeopathic intervention on heel pain and functional ability in patients with plantar fasciitis as measured by the Visual Analogue Scale (VAS) and the Plantar Fasciitis Pain and Disability Scale (PFPS) |
every 6-week intervals for 6 months |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
1. To evaluate the outcome of homoeopathic intervention on heel pain, general well-being, & quality of life (QoL) using the Outcome Related to Impact on Daily Living (ORDIL) scale
2. To assess the changes in plantar fascia thickness by ultrasonography & in calcaneal spur (if associated with plantar fasciitis) by digital radiography following homoeopathic intervention.
|
1. ORIDL Scales at 6 week intervals for 6 months.
2. To compare changes in plantar fascia thickness measured by ultrasonography (USG) at baseline & at the end of six months of treatment
To compare changes in calcaneal spur assessed by digital radiography at baseline & at the end of six months of treatment
|
|
|
Target Sample Size
|
Total Sample Size="165"
Sample Size from India="165"
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)
|
20/01/2024 |
| 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
Modification(s)
|
Years="2"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
As per a suitable journal |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This is a prospective, open-label clinical trial to evaluate the response to homeopathic intervention in plantar fasciitis, including calcaneal spur, which will be conducted at the Dr. Anjali Chatterji Regional Research Institute for Homoeopathy in Kolkata. All participants aged 18 to 65 years who have symptoms of plantar fasciitis (with or without calcaneal spur) will be studied. As per the inclusion criteria, clinically and radiologically diagnosed cases of plantar fasciitis will be treated with Individualized homeopathic medicine in centesimal potencies manufactured by a licensed homeopathic pharmaceutical company approved by the Council. The duration of the study intervention is six months. The primary outcome measures shall be assessment of symptoms clinically and utilizing the Plantar fasciitis pain & disability scale (PFPS), including VAS at every 6 weeks up to 6 months. The secondary outcome measures shall assess the general wellbeing and QoL using ORDIL Scales at every 6 weeks for 6 months and compare the changes in Calcaneal spur and in the thickness of Plantar Fascia through assessment by Radiography and USG respectively at baseline and at the end of 6 months of treatment. Upon completion of the study, data will be statistically analyzed (paired t-test and one-way repeated measures of ANOVA using appropriate statistical software (SPSS) to determine the usefulness of individualized homeopathy in managing symptoms of Plantar fasciitis and improving quality of life. The results are intended to be disseminated to the medical community. |