| CTRI Number |
CTRI/2018/01/011431 [Registered on: 18/01/2018] Trial Registered Retrospectively |
| Last Modified On: |
03/01/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare the effects of two treatments for mild to moderately severe knee osteoarthritis:injection within joints of hyaluronic acid and of dextrose,both within and around joints. |
|
Scientific Title of Study
|
Comparative study of intra articular high molecular hyaluronic acid and para articular dextrose prolotherapy in mild to moderate knee osteoarthritis. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ramapati Sanyal |
| Designation |
ASSOC PROF |
| Affiliation |
KPC Medical College |
| Address |
Deptt. of Anaesthesiology
KPC Medical College
1F Raja S C Mullick Road
Jadavpur
Kolkata
WEST BENGAL
700032
India |
| Phone |
|
| Fax |
|
| Email |
sanyalramapati@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Santi Ranjan Dasgupta |
| Designation |
Faculty |
| Affiliation |
ESI Institute of Pain Management |
| Address |
ESI Institute of Pain Management
ESI Hospital Sealdah,
3A & 3B Maharani Swarnamoyee Road, Kolkata 700009
Kolkata
WEST BENGAL
700009
India |
| Phone |
|
| Fax |
|
| Email |
santi.dasgupta10@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ramapati Sanyal |
| Designation |
ASSOC PROF |
| Affiliation |
KPC Medical College |
| Address |
Deptt. of Anaesthesiology
KPC Medical College
1F Raja S C Mullick Road
Jadavpur
Kolkata
WEST BENGAL
700032
India |
| Phone |
|
| Fax |
|
| Email |
sanyalramapati@gmail.com |
|
|
Source of Monetary or Material Support
|
| ESI Hospital Sealdah Kolkata |
|
|
Primary Sponsor
|
| Name |
ESI Hospital Saldah |
| Address |
3A and 3B Maharani Swarnamoyee Road
Kolkata 700009 |
| Type of Sponsor |
Other [Government 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 |
| Ramapati Sanyal |
ESI Institute of Pain Management |
ESI Hospitaal Sealdah,
3A & 3B Maharani Swarnamoyee Road, Kolkata 700009
Kolkata
WEST BENGAL |
9830163182
sanyalramapati@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee ESI Institute of Pain Management Sealdah |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Osteoarthritis of knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
12.5% dextrose |
25% dextrose diluted with equal volume of 2% preservative free lignocaine,2 ml intra artricularly and 0.5 ml para articularly at osteo tendinous junction. Only one treatment session. |
| Comparator Agent |
high molecular weight hyaluronic acid |
high molecular weight hyaluronic acid, one prefilled syringe containing 2 ml of solution injected intra articularly. |
|
|
Inclusion Criteria
|
| Age From |
50.00 Month(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1.Knee pain
2.Kellgren Lawrence grade I II III |
|
| ExclusionCriteria |
| Details |
1.Systemic disease
2.On anticoagulants
3.Previous intra articular steroid injection
4.Knee inflammation/ infection
5.Use of steroids in past two weeks
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Visual Analogue Scale (VAS)
|
two months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Western Ontario and Mcmaster University Arthritis Index (WOMAC)
|
2 MONTHS |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
29/12/2015 |
| Date of Study Completion (India) |
28/04/2016 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
none |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Osteoarthritis is a common disease of old age. Conservative methods like exercises and analgesics are the first step towards the treatment. Minimally invasive therapy for OA like high molecular weight hyaluronic acid is a standard treatment. However because of its cost it is not always affordable for all patients in a developing country like india. Intra articular and para articular dextrose is a novel treatment with no serious side effect and is very cheap. The aim of the present study was to compare the effects of the above two interventions with visual analogue scale and Western Ontario and Mcmaster University arthritis index. Thirty patients were randomly divided into groups of fifteen each. One received intra articular and para articular dextrose and the second group received high molecular weight hyaluronic acid. Single injection in each group. There was significant improvement in VAS and WOMAC score in the dextrose group when compared to hyaluronan group (p=0.011 and p=0.004,p<0.05 significant) at post procedure assessment at two months.
|