| CTRI Number |
CTRI/2018/10/016014 [Registered on: 15/10/2018] Trial Registered Prospectively |
| Last Modified On: |
22/09/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Homeopathic treatment of foot pain |
|
Scientific Title of Study
|
Efficacy of Individualized Homeopathic Medicines in Plantar Fasciitis:
A Double-blind, Randomized, Placebo-controlled Clinical Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1221-8429 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sana Shahid |
| Designation |
Postgraduate Trainee |
| Affiliation |
Mahesh Bhattacharyya Homoeopathic Medical College and Hospital |
| Address |
Drainage Canal Road, Doomurjola, Howrah 711104
Haora
WEST BENGAL
711104
India |
| Phone |
8478980104 |
| Fax |
|
| Email |
drsanashahid1503@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shubhamoy Ghosh |
| Designation |
Professor and Head, Department of Pathology and Microbiology |
| Affiliation |
Mahesh Bhattacharyya Homoeopathic Medical College and Hospital |
| Address |
Drainage Canal Road, Doomurjola, Howrah 711104
Haora
WEST BENGAL
711104
India |
| Phone |
9831034229 |
| Fax |
|
| Email |
shubhamoy67@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shubhamoy Ghosh |
| Designation |
Professor and Head, Department of Pathology and Microbiology |
| Affiliation |
Mahesh Bhattacharyya Homoeopathic Medical College and Hospital |
| Address |
Drainage Canal Road, Doomurjola, Howrah 711104
WEST BENGAL
711104
India |
| Phone |
9831034229 |
| Fax |
|
| Email |
shubhamoy67@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahesh Bhattacharyya Homoeopathic Medical College and Hospital; Drainage Canal Road, Doomurjola, Howrah - 711104; West Bengal; India |
|
|
Primary Sponsor
|
| Name |
Mahesh Bhattacharyya Homoeopathic Medical College and Hospital |
| Address |
Drainage Canal Road, Doomurjola, Howrah 711104, West Bengal, India |
| 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 |
| Sana Shahid |
M. B. Homoeopathic Medical College & Hospital |
OPD room no 4, Dept of Surgery; Drainage Canal Road, Doomurjola, Howrah 711104
Haora
WEST BENGAL |
8478980104
drsanashahid1503@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M722||Plantar fascial fibromatosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized homeopathic medicines in centesimal potencies plus conservative management |
Intervention is planned as administering indicated homeopathic remedies in centesimal potencies. Each dose will consist of 4-6 cane sugar globules 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. All medicines will be procured from a Good Manufacturing Practice (GMP) certified firm. Along with medicines, the intervention arm will receive conservative treatment, i.e., contrast bath, foot exercises plus use of shoes made of microcellular rubber. Duration of therapy is 3 months. |
| Comparator Agent |
Placebo plus conservative management |
This group will receive indistinguishable placebo along with conservative management. Each dose will consist of 4-6 cane sugar globules moistened with 90% v/v ethanol, to be taken orally on clean tongue with empty stomach. Along with placebo, this arm will receive conservative treatment, i.e., contrast bath, foot exercises plus use of shoes made of microcellular rubber. Duration of therapy is 3 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
a) Cases suffering from Plantar fascitis (ICD10 code M72.2)
b) Age 18-65 yrs
c) Both sexes
d) Literate patients; ability to read Bengali and/or English and capability and willingness to give informed consent and to comply with the study procedure |
|
| ExclusionCriteria |
| Details |
a) Cases too sick for consultation
b) Cases unwilling to stay after the doctor’s visit
c) Patients unable to read patient information sheet
d) Patients unwilling to take part or not giving consent to join the study
e) Cases suffering from calcaneal spur or some bony deformities or foot pathology
f) 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
g) Patient with psychiatric disorders
h) Undergoing homoeopathic treatment for chronic disease within last 6 months
i) Self-reported immune-compromised state
j) Substance abuse and/or dependence
k) Pregnant and lactating women |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Foot Function Index (FFI) questionnaire |
At baseline, every month up to 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| None |
NA |
|
|
Target Sample Size
|
Total Sample Size="128"
Sample Size from India="128"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/11/2018 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet; to be published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Plantar fasciitis affects millions of Americans every or 10 percent of
the population of the United States. Economic costs from third-party payers relating to the treatment of
plantar fasciitis have been estimated to range from $192 to $376 million per
year. Recent findings suggest plantar fasciitis be a chronic degeneration
causing marked thickening and fibrosis of the plantar fascia along with
collagen necrosis, chondroid metaplasia, and calcification. Little convincing evidence are there to support various approaches for treating
plantar fasciitis including homeopathy. This trial is aimed at exploring the efficacy of individualised homeopathic medicines against placebo in treatment of plantar fasciitis. In this prospective, double
blind, randomised, placebo controlled, parallel arm trial at Mahesh
Bhattacharyya Homoeopathic Medical College and Hospital, 128 patients suffering
from plantar fasciitis will be randomised in 1:1 ratio into either individualised
homeopathic medicines or identical placebo. Foot Function Index (FFI) will be used as the outcome measure, measured at baseline, and every
month up to 3 months. At the end of 3 months, comparative analysis will be
carried out to detect group differences, if any. Results will be published in
scientific journals. |