| CTRI Number |
CTRI/2019/04/018428 [Registered on: 05/04/2019] Trial Registered Prospectively |
| Last Modified On: |
04/04/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A Study of Efficacy of Intra-Articular Hyaluronic Acid in relief of pain in Osteoarthritis knee. |
|
Scientific Title of Study
|
A Study of Efficacy of Intra-Articular Hyaluronic Acid in Relief of pain in Kellgren and Lawrence Grade 2 and 3 Osteoarthritis Knee |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
PANKAJ SEHRAWAT |
| Designation |
PG Resident Doctor |
| Affiliation |
ESIC PGIMSR,Basaidarapur,New Delhi |
| Address |
Department of Orthopaedics,ESIC PGIMSR,Basaidarapur
West
DELHI
110015
India |
| Phone |
|
| Fax |
|
| Email |
psehrawat1990@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Krishan Kumar |
| Designation |
Senior Resident Doctor |
| Affiliation |
ESIC PGIMSR Basaidarapur,New Delhi |
| Address |
Department of Orthopaedics,ESIC PGIMSR,Basaidarapur
West
DELHI
110015
India |
| Phone |
|
| Fax |
|
| Email |
doc.krriss@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ramavtar |
| Designation |
Assistant Professor |
| Affiliation |
ESI Corporation,Ministry of labour and employment,Govt of India |
| Address |
Department of Orthopaedics,ESIC PGIMSR,Basaidarapur
West
DELHI
110015
India |
| Phone |
|
| Fax |
|
| Email |
docramavtar@gmail.com |
|
|
Source of Monetary or Material Support
|
| ESIC Model Hospital and PGIMSR,Basaidarapur,New Delhi |
|
|
Primary Sponsor
|
| Name |
Employees State Insurance CorporationMinistry of labour and Employment Government of India |
| Address |
ESIC PGIMSR,Basaidarapur,New Delhi |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Pankaj Sehrawat |
ESIC PGIMSR ,Basaidarapur,New Delhi |
Room No 28,Department of Orthopaedics
West
DELHI |
9654492424
psehrawat1990@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC-ESI PGIMSR,Basaidarapur,New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conservative Treatment Group |
This group of patients suffering from osteoarthritis knee will be treated with conservative means like locally applied analgesics,crepe bandage and lifestyle modifications. |
| Intervention |
Hyaluronic acid |
This group of patients suffering from Osteoarthritis knee will be treated with Intra Articular Hyaluronic Acid. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
patients of Kellgren and Lawrence Grade 2 and 3 osteoarthritis of the knee of any sex from 40 to 80 years age group |
|
| ExclusionCriteria |
| Details |
Patients with known hypersensitivity to hyaluronate preparation
cases of infection or skin diseases in area of injection site
patients who had received intra articular hyaluronic acid within 4 weeks before the study
infected joints
uncontrolled diabetes
large effusion
pregnant and lactating women
rheumatoid arthritis
severe osteoarthritis with kellgren and Lawrence grade 4 osteoarthritis knee
patients who have undergone joint replacement surgery in either knee |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Visual Analogue Scale |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) |
6 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
06/04/2019 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This trial is undertaken to evaluate the efficacy of intra articular injection of hyaluronic acid in relief of pain in Kellgren and Lawrence grade 2 and 3 of osteoarthritis knee in comparison to conservative treatment such locally applied analgesics, crepe bandage and lifestyle modification patterns. |