| CTRI Number |
CTRI/2025/06/088463 [Registered on: 10/06/2025] Trial Registered Prospectively |
| Last Modified On: |
04/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Post approval, observational study |
| Study Design |
Other |
|
Public Title of Study
|
The impact for fixed dose CombinatiOn of trypsin, chyMotrypsin, Aceclofenac, Paracetamol for MinOr SurgEries (COMPOSE II) |
|
Scientific Title of Study
|
A post approval observational study to assess the impact
for fixed dose CombinatiOn of trypsin, chyMotrypsin,
Aceclofenac, Paracetamol for MinOr SurgEries (COMPOSE II) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sanjay B Londhe |
| Designation |
MS Orthopedic |
| Affiliation |
Nanavati super speciality Hospital |
| Address |
Ground Floor room no. 4 departmeent of orthopedic Satidham Bldg Subhash Road Vile Parle east Mumbai 400 057
Mumbai
MAHARASHTRA
400057
India |
| Phone |
9821260453 |
| Fax |
|
| Email |
sanlondhe@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjay B Londhe |
| Designation |
MS Orthopedic |
| Affiliation |
Nanavati super speciality Hospital |
| Address |
Ground Floor room no. 4 departmeent of orthopedic Satidham Bldg Subhash Road Vile Parle east Mumbai 400 057
Mumbai
MAHARASHTRA
400057
India |
| Phone |
9821260453 |
| Fax |
|
| Email |
sanlondhe@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Altaf Makwana |
| Designation |
Assistant General Manager |
| Affiliation |
Torrent Pharmaceuticals Ltd |
| Address |
Torrent House Off Ashram Road department of management room no.6 Ahmedabad 380009
Ahmadabad
GUJARAT
380009
India |
| Phone |
7069000569 |
| Fax |
|
| Email |
AltafMakwana@TorrentPharma.com |
|
|
Source of Monetary or Material Support
|
| Torrent Pharmaceuticals Ltd
Torrent House Off Ashram Road Ahmedabad 380009 |
|
|
Primary Sponsor
|
| Name |
Torrent Pharmaceuticals Ltd |
| Address |
Torrent House Off Ashram Road Ahmedabad 380009 Gujarat India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rajesh Rohira |
Ananda Hospital |
Ananda Hospital room no.6 department of orthopedic Krimson Park SV Road Amboli Andheri West Mumbai
Mumbai
MAHARASHTRA |
9820143494
Rajeshtrohira@yahoo.com |
| Dr Sanjay B Londhe |
Dr Sanjay Londhe Clinic |
Ground Floor room no. 4 department of orthopedic Satidham Bldg Subhash Road Vile Parle east Mumbai 400 057
Mumbai
MAHARASHTRA |
9821260453
sanlondhe@yahoo.com |
| Dr Tanay Ram Prabhoo |
Dr. Prabhoos Ortho Spine and Gynec Care Clinic |
Dr Prabhoos Ortho Spine and Gynec Care Clinic room no. 4 deparment of orthopedic Rajiv Royals Chakala Andheri East Mumbai
Mumbai
MAHARASHTRA |
9819010221
tanayprabhoo@gmail.com |
| Dr Sunil Shetty |
Sai Asha Hospital |
Sai Asha Hospital 1st Floor room no. 5 department of orthopedic Laxcon Plaza Nerul Navi Mumbai
Mumbai
MAHARASHTRA |
9821288076
dr.sunilshetty@yahoo.com |
| Dr Amin Shah |
Sapna Healthcare Center |
Sapna Healthcare Center room no. 6 department of orthopedic Ghatkopar west Mumbai
Mumbai
MAHARASHTRA |
9821010047
aminshah22@gmail.com |
| Dr Girish Bakshi |
Satyam Multi Speciality Hospital |
Satyam Multi Speciality Hospital Plot 12 room no.5 department of orthopedic Sector 14 Landmark Opposite DMart Navi Mumbai
Mumbai
MAHARASHTRA |
9820218198
gdbakshi@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| Suraksha Ethics Committee |
Approved |
| Suraksha Ethics Committee |
Approved |
| Suraksha Ethics Committee |
Approved |
| Suraksha Ethics Committee |
Approved |
| Suraksha Ethics Committee |
Approved |
| Suraksha Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M708||Other soft tissue disorders related to use, overuse and pressure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
95.00 Year(s) |
| Gender |
Both |
| Details |
Male or female patients of equal to and greater than 18 years
Treatment naïve patients with Orthopedic surgery General surgery and Soft tissue injuries requiring
Debridement which qualify for NSAID plus oral enzyme combination at discretion of physician |
|
| ExclusionCriteria |
| Details |
Patients treated with gabapentanoids pregabalin gabapentin for neuropathic pain
Cases with hepatic enzyme elevation of 5xULN or CKD with proteinuria greater than Stage 3
Active or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding)
Hypersensitivity reactions (eg. Asthma rhinitis angioedema or urticaria) in response to ibuprofen aspirin or other non-steroidal anti-inflammatory drugs
Uncontrolled status for congestive heart failure (NYHA II-IV) ischaemic heart disease peripheral arterial
disease and/or cerebrovascular disease
History of gastrointestinal bleeding or perforation related to previous NSAIDS therapy
Active bleedings or bleeding disorders
Hypersensitivity to trypsin-chymotrypsin paracetamol Aceclofenac or any of the other constituents
Pregnancy and Lactation
Patients who have any condition or medicine that in the opinion of the investigator did not the justify their inclusion in the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Visual analogue scale (VAS) for pain, inflammation and/or swelling assessed at 24 hrs. Day 3 and Day 7 (± 2
days) |
at 24 hrs. Day 3 and Day 7 (± 2
days) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Functional assessment scale score for impact on Personal care Daily activities Sleep and Affected area or limb
movement assessment at 24 hrs. and Day 3 and Day 7 (± 2 days)
Clinical global impression for Efficacy assessed at Day 7 (± 2 days)
Clinical global impression for Tolerability assessed at Day 7 (± 2 days)
hs-CRP assessment at Day 3 and 7 (± 2 days) in the overall group
CBC with DLC assessment at Day 3
Safety assessment for Common Adverse events greater than 1 percent |
at 24 hrs. Day 3 and Day 7 (± 2
days) |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
24/06/2025 |
| 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
|
|