| CTRI Number |
CTRI/2024/04/065685 [Registered on: 15/04/2024] Trial Registered Prospectively |
| Last Modified On: |
04/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Role of Homoeopathic Medicines versus physiotherapy in the treatment of Plantar Fasciitis |
|
Scientific Title of Study
|
A Comparative Study of Usefulness of Individualized Homoeopathic Medicines With Physiotherapy in the Management of Plantar Fasciitis: Randomized Placebo Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Swati Saini |
| Designation |
P G Scholar |
| Affiliation |
Bakson Homoeopathic Medical College and Hospital |
| Address |
Room no B 17
Basement
36 B Knowledge Park 1
Greater Noida
N/A
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
7982976283 |
| Fax |
|
| Email |
swatisaini.saini660@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Swati Saini |
| Designation |
P G Scholar |
| Affiliation |
Bakson Homoeopathic Medical College and Hospital |
| Address |
Room no B 17
Basement
36 B Knowledge Park 1
Greater Noida
N/A
UTTAR PRADESH
201310
India |
| Phone |
7982976283 |
| Fax |
|
| Email |
swatisaini.saini660@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Man Mohan Chamoli |
| Designation |
Assisstant Professor and Guide |
| Affiliation |
Bakson Homoeopathic Medical College and Hospital |
| Address |
Room no B 17
Basement
36 B Knowledge Park 1
Greater Noida
N/A
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
7838034913 |
| Fax |
|
| Email |
manu0001sm@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bakson Homoeopathic Medical College and Hospital |
|
|
Primary Sponsor
|
| Name |
Bakson Homoeopathic Medical College and Hopital |
| Address |
Room No G22
Ground Floor
Principal Office
Bakson Homoeopathic Medical College and Hospital
36-B,Knowledge Park-1,Greater Noida, Uttar Pradesh [ |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Swati Saini |
Bakson Homoeopathic Medical College and Hospital |
Out Patient Department No 1
Ground Floor
Bakson Homoeopathic Medical College and Hospital
Gautam Buddha Nagar
UTTAR PRADESH |
7982976283
swatisaini.saini660@gmail.com |
| Dr Swati Saini |
Dr D P Rastogi Central Research Institute of Homoeopathy |
Out Patient Department
Room No 110
Ground Floor
A-1/1 Sector 24
Noida
Gautam Buddha Nagar
UTTAR PRADESH |
7982976283
swatisaini.saini660@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Bakson Homoeopathic Medical College and Hospital |
Approved |
| Kendriya Homoeopathy Anusandhan Parishadh |
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 Medicine |
15 months study
6 months: enrollment of cases
6 months: followup of cases
3 months: data analysis
Oral route of administration
Pill form
30 pill size
Centisemal scale
First dose after taking the
case
Subsequent doses after each follow up
Potency according to the case
|
| Comparator Agent |
NIL |
N/A |
| Intervention |
Placebo |
15 months study
6 months: enrollment of cases
6 months: followup of cases
3 months: data analysis
Oral route of administration
Poppy sized globule
30 pill size
Centisemal scale
First dose after taking the case
Subsequent doses after each follow up
Potency according to the case
|
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
59.00 Year(s) |
| Gender |
Both |
| Details |
1.Those aged between 19 and 59 years of either sex
2.Cases suffering from Plantar Fasciitis
3.Willing to take only homeopathic medicines.
4.Will give written consent to participate in the study
|
|
| ExclusionCriteria |
| Details |
1 Suffering from any bony deformity
2 Cases suffering from uncontrolled systemic illness (metabolic diseases like diabetes mellitus and neurological diseases)
3 Pregnant or puerperal or lactating women
4 Participant with psychiatric diseases and self-reported immune-compromised states.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| It is expected to have positive changes on Foot Function Index (FFI) scale |
15 months study
6 months enrollment
6 months follow up
3 months data analysis
FFI scale to be used at baseline, 4 weeks, 8 weeks,12 weeks till 24 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
N/A |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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)
|
19/04/2024 |
| 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
|
Years="1"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is to assess the role of homeopathic medicines in the treatment of plantar fasciitis. Sample size :64 Randomized placebo controlled trial- 15 months study Scale used for assessment: Foot Function Index It is expected to see positive changes in Foot Function Index |