| CTRI Number |
CTRI/2025/02/080689 [Registered on: 17/02/2025] Trial Registered Prospectively |
| Last Modified On: |
15/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani
Other (Specify) [Therapeutic] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of pashoya therapy on pain management and functional improvement in heel pain. |
|
Scientific Title of Study
|
Evaluation of the Effect of Pashoya Therapy on Pain Management and Functional Improvement in Plantar Fasciitis Patients |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SAIMA NUZHAT MOHAMMADI |
| Designation |
BUMS FINAL YEAR STUDENT |
| Affiliation |
AJMAL KHAN TIBBIYA COLLEGE & HOSPITAL |
| Address |
Department of Ilaj-bit-Tadbeer, Faculty of Unani Medicine,
AMU,Aligarh
Aligarh
UTTAR PRADESH
202002
India
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
8271880544 |
| Fax |
|
| Email |
nuzhatsnm@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Mohd Anwar |
| Designation |
PROFESSOR |
| Affiliation |
Department of Ilaj-bit-Tadbeer, Faculty of Unani Medicine, AMU |
| Address |
Department of Ilaj-bit-Tadbeer,Faculty of Unani Medicine, AMU,
Aligarh
Aligarh
UTTAR PRADESH
202002
India
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9045655238 |
| Fax |
|
| Email |
manwar.ib@amu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
SAIMA NUZHAT MOHAMMADI |
| Designation |
BUMS FINAL YEAR STUDENT |
| Affiliation |
AJMAL KHAN TIBBIYA COLLEGE & HOSPITAL |
| Address |
Department of Ilaj-bit-Tadbeer,Faculty of Unani Medicine, AMU,
Aligarh
Aligarh
UTTAR PRADESH
202002
India
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
8271880544 |
| Fax |
|
| Email |
nuzhatsnm@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Ilaj-bit-Tadbeer,Faculty of Unani Medicine, AMU, Aligarh, U.P. India 202002 |
|
|
Primary Sponsor
|
| Name |
Department of Ilaj bit Tadbeer Ajmal Khan Tibbiya College |
| Address |
Faculty of Unani Medicine, AMU, Aligarh 202002 |
| 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 SAIMA NUZHAT MOHAMMADI |
Department of Ilaj-bit-Tadbeer, AKTC |
Faculty
of Unani
Medicine,Ajmal Khan
Tibbiya
College,AMU,Aligarh,
202002
Aligarh
UTTAR PRADESH
Aligarh
UTTAR PRADESH |
8271880544
nuzhatsnm@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Faculty of Unani Medicine, AMU, Aligarh |
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 |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Pashoya |
Method of Preparation of Pashoya
All the ingredients sourced from reputable suppliers will be dried and mixed with water and boiled. The mixture will be strained and when the temperature is suitable, foot will be immersed in the mixture. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Adults aged 18-65 years
Clinically diagnosed with plantar fasciitis based on the presence of heel pain for at least three months.
Pain levels of at least 4 on a scale of 0 to 10 during initial assessment.
Willingness to participate in the study and provide informed consent |
|
| ExclusionCriteria |
| Details |
Aged less than 18 and more than 65 years
History of surgical intervention for plantar fasciitis.
Recent treatment with corticosteroids or other anti-inflammatory medications within the last month.
Comorbid conditions affecting foot health (e.g., severe osteoarthritis, neuropathy).
Pregnancy or lactation.
Allergies to any components of Pashoya or placebo.
Patients with uncontrolled diabetes mellitus.
Patients with uncontrolled hypertension
Assessment |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Numeric Pain Rating Scale (NPRS)
Foot Function Index (FFI) |
Visit 1st : Baseline
Visit 2nd : 7th day
Visit 3rd : 14th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Heel pain particularly in the morning or following inactivity during the day
Stiffness of foot
Tenderness of heel
Swelling or inflammation in heel area |
Visit 1st : Baseline
Visit 2nd : 7th day
Visit 3rd : 14th day |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
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)
|
26/02/2025 |
| 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="0"
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 research proposal aims to evaluate the therapeutic potential of Pashoya as a complementary treatment for plantar fasciitis. By conducting a clinical study to assess its impact on pain reduction, inflammation, and functional improvement, the study seeks to determine whether Pashoya can provide effective relief and serve as a viable alternative or adjunct to conventional treatments. The findings could expand the current therapeutic options available to patients and contribute to a more integrative approach to managing plantar fasciitis. |