CTRI/2021/01/030508 [Registered on: 15/01/2021] Trial Registered Prospectively
Last Modified On:
19/04/2022
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
Comparison of combination of Diclofenac, Paracetamol, Trypsin, and Chymotrypsin versus combination of Diclofenac and Paracetamol in patient with soft tissue enjury.
Scientific Title of Study
A phase IV, randomized, multicentre, prospective, open-label, comparative, post-marketing study to evaluate safety & efficacy of combination of Diclofenac, Paracetamol, Trypsin and Chymotrypsin versus combination of Diclofenac and Paracetamol in patients with soft tissue injury.
All India Institute of Medical Sciences, Bhubneshwar
All India Institute of
Medical Sciences, OPD
room, Department of
Radiotherpay, Day
Care division, Village
Sijua, Patrapada, Bhubaneshwar – 751 Khordha ORISSA
9438884156
ortho_mantu@aiimsbhubaneswar.edu.in
Dr Yandrapati Gnana Sundara Raju
Andhra Medical College, King George Hospital
Maharanipeta, Visakhapatnam,
Andhra Pradesh- 5300O2, India.
Visakhapatnam ANDHRA PRADESH
9573606609
drysundarrajuresearch@gmail.com
Dr Sajal Mitra
Government Medical College and Hospital, Nagpur
Government Medical College and Hospital,
Dept of Orthopedics, OT-E,
Opp. Ward No. 26, 1st floor, Nagpur. Nagpur MAHARASHTRA
9373114929
sajalmitra2007@yahoo.com
Dr Ramesh Vardhan
Great Eastern Medical School And Hospital
Ragolu Srikakulam
Andhra Pradesh - 532484 India
Srikakulam ANDHRA PRADESH
9448172069
drrameshvardhanresearch@gmail.com
Dr Abhimanyu Makane
Ishwar Institute of Health Care, Aurangabad
Ishwar Institute of Health Care, Department of research, 1st floor, Room no. 103, Ishwar heights, plot no. 7, Gut no. 6/1, Beside Punjabi Bhawan, Padegaon, Aurangabad-431002 Aurangabad MAHARASHTRA
9822314268
abhimanyu.makane@gmail.com
Dr Nikalje Rajkumar Gautam
Lifepoint Multispeciality Hospital, Pune
Lifepoint Multispeciality Hospital, 145/1, Mumbai-Bangalore Highway, Near Hotel Sayaji, Wakad, Pune 411 057 Pune MAHARASHTRA
9028560535
nikaljeraj80@gmail.com
Dr Sunil Maheshwari
Medilink Hospital and Research Centre, Ahmedabad
Medilink Hospital and Research Centre, Near Shyamal Cross Road, 132 ft. Ring Road, Satellite, Ahmedabad –380015 Ahmadabad GUJARAT
9898983555
drsunilmaheshwari@gmail.com
Dr Ronak B Shah
Poojan Multispecialty Hospital
1st Floor, Navnidhi Avenue,
Nr. A-One School, Subhash Chowk,
Memnagar, Gurukul, Ahmedabad-380052, Gujarat, India
Ahmadabad GUJARAT
All patients in the study will receive combination of Diclofenac and Paracetamol 1 tablet twice daily for 5 - 7 days.
Intervention
Combination of Diclofenac, Paracetamol, Trypsin and Chymotrypsin
All patients in the study will receive combination of Diclofenac, Paracetamol, Trypsin and Chymotrypsin tablets 1 tablet twice daily for 5 - 7 days.
Inclusion Criteria
Age From
18.00 Year(s)
Age To
65.00 Year(s)
Gender
Both
Details
1. Male or female patients between 18-65 years of age.
2. Patients with soft tissues injuries associated with inflammation & swelling like sprains, strains, hematomas (Sub-dermal type only), contusion, acute sports injuries (excluding suspected fractures), seen within 24 hours of the injury at screening.
3. Patients with pain VAS score between 4 - 6
4. Patients with ankle injury not requiring interventional treatment
5. Patients willing to give written informed consent and willing to comply with trial protocol
ExclusionCriteria
Details
1. Patients previously hypersensitive to diclofenac, paracetamol, trypsin or chymotrypsin
2. Patients with significant gastrointestinal complications, such as but not limited to the
following conditions:
a. Gastrointestinal ulcer
b. Gastrointestinal bleeding
c. Crohn’s disease or ulcerative colitis.
3. Any long standing/chronic inflammatory condition like rheumatoid arthritis, osteoarthritis or spondylitis where the patient had been on long term anti-inflammatory drugs including nonsteroidal anti-inflammatory drugs, corticosteroids or analgesics.
4. Patients with wounds, tissue abscesses and cellulitis.
5. Patients with injuries (such as sprains/strains) requiring immobilization for more than 48 hours, orthopaedic or surgical intervention.
6. Patients known to have established congestive heart failure, cerebrovascular disease, renal and liver disease or any clinically significant disease as per investigator discretion.
7. Patient with any abnormal renal and hepatic function.
8. Patients who are known seropositive cases of HIV, Hepatitis B or Hepatitis C.
9. Patients with localized skin disease (e.g. eczema, psoriasis etc.) at the site of injury that may interfere in evaluation of the injury.
10. Patients who had participated in any clinical trial within one month prior to enrolment.
11. Patients who have taken prohibited medications (other NSAIDs, opioid analgesics and
systemic corticosteroids) in last 7 days.
12. Pregnant and lactating women or the women of child bearing age who are not practicing
effective method of contraception.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Centralized
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
The primary objective of this study is to evaluate the efficacy of combination of Diclofenac,
Paracetamol, Trypsin and Chymotrypsin versus combination of Diclofenac and Paracetamol
in terms of percentage reduction in swelling from baseline to End of treatment.
Patients completing treatment from baseline to EOT i.e. day 6 to day 8
Secondary Outcome
Outcome
TimePoints
1. To evaluate change in VAS score from baseline to EOT
2. To evaluate rate of pain relief during the study.(reduction in VAS score from baseline)
3. Use of any rescue medication
4. To evaluate the safety and tolerability.
Patients completing treatment from baseline to EOT i.e. day 6 to day 8
Target Sample Size
Total Sample Size="220" Sample Size from India="220" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
A phase IV, randomized, multicentre, prospective, open-label, comparative, post-marketing study to evaluate safety & efficacy of combination of Diclofenac, Paracetamol, Trypsin and Chymotrypsin versus combination of Diclofenac and Paracetamol in patients with soft tissue injury.
Study Objective(s):
Primary Objective:
1. The primary objective of this study is to evaluate the efficacy of combination of Diclofenac, Paracetamol, Trypsin and Chymotrypsin versus combination of Diclofenac and Paracetamol in terms of reduction in swelling score from baseline to End of treatment.
Secondary objectives:
1. To evaluate change in VAS score from baseline to EOT
2. To evaluate rate of pain relief during the study. (VAS score)