| CTRI Number |
CTRI/2009/091/000813 [Registered on: 12/10/2009] |
| Last Modified On: |
|
| Post Graduate Thesis |
|
| Type of Trial |
|
|
Type of Study
|
|
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the effects of a combination of trypsin-chymotrypsin enzymes and diclofenac in comparison to diclofenac alone in patients with soft tissue injuries. |
|
Scientific Title of Study
|
A randomized, double blind, comparative, parallel-group clinical trial to evaluate the efficacy and safety of a combination of trypsin-chymotrypsin enzymes and diclofenac (TCD) in comparison to diclofenac alone in the management of inflammation due to soft tissue injuries |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Elder/CT/III/TCD1/08 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Mrs. K.C.P. Walavalkar |
| Designation |
|
| Affiliation |
|
| Address |
Snehal Hospital
Gokhale Road
Thane
MAHARASHTRA
400602
India |
| Phone |
09819714755 |
| Fax |
NIL |
| Email |
charusheilawal@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manas V. Vyas |
| Designation |
|
| Affiliation |
Elder Pharmaceuticals Ltd. |
| Address |
C-9, Dalia Industrial Estate
Veera Desai Road, Andheri (W)
Mumbai
MAHARASHTRA
400053
India |
| Phone |
022-66485326 |
| Fax |
022-66929172 |
| Email |
drmanas@elderindia.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Manas Vyas |
| Designation |
|
| Affiliation |
|
| Address |
C-9, Dalia Industrial Estate
Veera Desai Road, Andheri (W)
Mumbai
MAHARASHTRA
400053
India |
| Phone |
022-66485326 |
| Fax |
022-66929172 |
| Email |
drmanas@elderindia.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Elder Pharmaceuticals Ltd.,
C-9, Dalia Industrial Estate,
Veera Desai Road, Off New Link Road,
Andheri (W), Mumbai ? 53.
|
| Address |
|
| Type of Sponsor |
|
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. Abdul Waheed |
5, Jumman Khudabaksh Chawl |
Sewri X Road,Wadala-400031
Mumbai
MAHARASHTRA |
022-24127971
NIL
drwaheed2009@rediffmail.com |
| Dr. Raj Kumar Mookhey |
Jasraj Hospital |
Dr Gor?s Apt.,MG Road, Panch Rasta, Mulund (W)-400080
Mumbai
MAHARASHTRA |
09820553806
NIL
raj.max@hotmail.com |
| Dr. Mrs. K.C.P. Walavalkar |
Snehal Hospital |
Gokhale Road,Thane (W)-400602
Thane
MAHARASHTRA |
09819714755
NIL
charusheilawal@rediffmail.com |
| Dr. Amit V Karkhanis |
Twacha Centre |
Opp Bank of Baroda,Thane (W)-400602
Thane
MAHARASHTRA |
09821141155
NIL
avk209@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Centre: 5, Jumman Khudabaksh Chawl; Investigator: Dr. Abdul Waheed; Ethics Committee: Alert Ethics Committee |
Approved |
| Centre: Jasraj Hospital; Investigator: Dr. Raj Kumar Mookhey; Ethics Committee: Alert Ethics Committee |
Approved |
| Centre: Snehal Hospital; Investigator: Dr. K. C. P. Walavalkar; Ethics Committee: Alert Ethics Committee |
Approved |
| Centre: Twacha Centre; Investigator: Dr. Amit V. Karkhanis; Ethics Committee: Alert Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Inflammation due to soft tissue injuries, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Diclofenac Sodium 50 mg tablets |
Three times a day for seven days |
| Intervention |
Trypsin: Chymotrypsin (6:1) 50,000 A.U + Diclofenac Pottasium 50 mg |
Three times a day for seven days |
|
|
Inclusion Criteria
|
| Age From |
|
| Age To |
|
| Gender |
|
| Details |
1) Adult patients aged between 18 and 65 years with soft tissue injuries like sprains, strains, stress injuries, ecchymosis, hematomas and lacerations seen within 24 hours of the injury
2) Patients aged between 18 and 65 years.
3) Patients who have given their written informed consent
4) Patients of childbearing years who are using appropriate contraceptive methods for 3 weeks prior to the study and throughout the duration of the study.
The following patients may also be included:
1. Clean Lacerated Wounds (non infected) requiring suturing.
2. Patients with healed fractures more than 3 months old
|
|
| ExclusionCriteria |
| Details |
1) Any long standing/ chronic inflammatory condition like Rheumatoid Arthritis, Osteoarthritis or Spondylitis where the patient has been on long term NSAIDs, Anti-Inflammatory drugs or Analgesics.
2) Infected wounds, Tissue abscesses and Cellulitis
3) Patients with Fracture if less than 3 months old.
4) Post operative cases
5) Patients who have Diabetes/ Raised Blood Sugar
6) Pregnant or breast-feeding women.
7) Patients who are simultaneously participating in another clinical trial with an unlicensed drug or who have done so within a one month period.
8) Patients with a known hypersensitivity to TC or Diclofenac
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Recovery from the injury, assessed by the Global score of the evaluated parameters of inflammation. |
End of study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Relief of individual symptoms of inflammation assessed by
the individual symptom score for pain, swelling and restriction of movement
|
End of study |
|
|
Target Sample Size
|
Total Sample Size="0"
Sample Size from India=""
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 3 |
|
Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
25/10/2009 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years=""
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Completed |
| Recruitment Status of Trial (India) |
|
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a randomized, double blind, parallel group, multi-centre trial comparing the efficacy and safety of a combination of trypsin-chymotrypsin enzymes plus diclofenac (TCD) and diclofenac alone in the management of inflammation due to soft tissue injuries. A total of 200 patients are proposed to be enrolled at 4 centres in India. The anticipated date of enrollment of patients is October 25, 2009. The primary end-point of the study will be recovery from the injury, assessed by the global score of the evaluated parameters of inflammation. The secondary end-point will be relief of individual symptoms of inflammation such as pain, swelling and restriction of movement assessed by individual symptom scores. |