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CTRI Number  CTRI/2018/02/011764 [Registered on: 07/02/2018] Trial Registered Retrospectively
Last Modified On: 08/06/2017
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   comparison between 3 steroid injections for treating heel pain 
Scientific Title of Study   comparative study of local injections of Methyl prednisolone, triamcinolone and dexamethasone in management of plantar fascitis 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr shaikh Huzaif Badiuddin 
Designation  Resident in pharmacology 
Affiliation  MGMs medical college, Aurangabad 
Address  Department of pharmacology, MGM Medical College, N-6 cidco, Aurangabad.

Aurangabad
MAHARASHTRA
431001
India 
Phone    
Fax    
Email  huzaifshaikh001@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr shaikh Huzaif Badiuddin 
Designation  Resident in pharmacology 
Affiliation  MGMs medical college, Aurangabad 
Address  Department of pharmacology,MGMs medical college, Aurangabad.

Aurangabad
MAHARASHTRA
431001
India 
Phone  9156495919  
Fax    
Email  huzaifshaikh001@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr shaikh Huzaif Badiuddin 
Designation  Resident in pharmacology 
Affiliation  MGMs medical college, Aurangabad 
Address  Department of pharmacology,MGMs medical college, Aurangabad

Aurangabad
MAHARASHTRA
431001
India 
Phone  9156495919  
Fax    
Email  huzaifshaikh001@gmail.com  
 
Source of Monetary or Material Support  
MGMs medical college, Aurangabad 
 
Primary Sponsor  
Name  no 
Address  no 
Type of Sponsor  Other [no] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Deepak bhosle  Department of orthopaedics  MGM medical college N6 Cidco Aurangabad
Aurangabad
MAHARASHTRA 
9049484204

drdeepakbhosle@gmail.com 
Dr shaikh huzaif badiuddin  Department of Pharmacology  4th floor MGM medical college N6 cidco Aurangabad
Aurangabad
MAHARASHTRA 
9156495919

huzaifshaikh001@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
MGM-ECRHS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Plantar fascitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Injection dexamethasone  Injection dexamethasone which is glucocorticoid will be given stat locally in the heel of patients of group C 
Intervention  injection methyl prednisolone  injection methyl prednisolone which is a glucocorticoid will be given stat locally in the heel to patients of group A 
Comparator Agent  Injection triamcinolone  Injection triamcinolone which is a glucocorticoid will be given stat locally in heel to patients of group B 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Patient willing to participate in the study and give consent.
2.Age group of 18-65 years of either sex.
3.Diagnosed cases of plantar fasciitis having symptoms for > 6 weeks.
4.Patients who had a fair trial of other conservative treatment but got no relief.
5.Patients who have not taken the study injectables previously.
 
 
ExclusionCriteria 
Details  1.Pregnant and lactating women.
2.Patients who are immunocompromised.
3.Patients with history of diabetes, hypertension and tuberculosis.
4.Patient having history of infection in last 3 months
5.Patients with history of psychiatric disorders.
6.Patient with history of peptic ulcer
7.Patients with history of osteoporosis.
8.Patients with history of trauma to heel.

 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
reduction in pain  At the end of 2 and 4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
reduction in discomfort  At the end of 2 and 4 weeks 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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 4 
Date of First Enrollment (India)   01/03/2017 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   no 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

A prospective, randomized, three armed, comparative and open label study will be conducted. Study will be conducted as per ICH-GCP guidelines. Patients presenting with heel pain will be screened and clinical examination will be performed by the orthopaedic surgeons in the orthopaedic OPD. Clinically diagnosed cases of plantar fasciitis would then be subjected to investigations like X-ray, ultrasonography of heel, complete blood count, fasting and post meal sugar and serum uric acid levels for confirming the diagnosis and for finding the pathology. Patients fulfilling the inclusion criteria would be enrolled in the study. Written informed consent in patients own language will be obtained. Three groups of 20 patients each will be made. Randomization will be done using chit method. Group A patients would be given injection Methyl prednisolone 40 mg stat in heel, Group B patients would be given injection Triamcinolone 40 mg stat in heel and Group C patients would be given injection Dexamethasone 4 mg stat in heel. All injections will be given by orthopaedic surgeons in procedure room under all aseptic precautions.

Pain intensity will be assessed at start, at 2 weeks and at 4 weeks of starting the treatment using:

·         Visual analogue scale (VAS)

 

 

 
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