A Clinical Study to evaluate the safety and efficacy of Fixed Dose Combination of Trypsin-Chymotrypsin, Aceclofenac and Paracetamol Tablets.
- Conditions
- Health Condition 1: S934- Sprain of ankle
- Registration Number
- CTRI/2022/06/043590
- Lead Sponsor
- Synokem Pharmaceuticals Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 200
1. Male or female patients aged between 18 to 65 years (both inclusive).
2. Patients with acute painful traumatic condition of orthopaedics such as ankle sprain.
3. Patients with pain at baseline must be � 30 mm on a 0- 100 mm Visual Analogue Scale.
4. Patient with ability to understand and provide written informed consent form, which must have been obtained prior to screening.
5. Patients willing to comply with the protocol requirements.
1. Patients with known history of intolerance, hypersensitivity or any other contraindication to study drug.
2. Patients with clinical laboratory evaluations are not within the reference range for the testing laboratory and the results are deemed clinically significant by the investigator.
3. Patients treated with Opioids & Corticosteroids within 1 week prior to the study.
4. Patients with chronic and degenerative conditions of pain.
5. Pregnant or lactating women.
6. Female patients who are of childbearing potential and who are neither surgically sterilized nor willing to use reliable contraceptive methods (like hormonal, barrier methods or intrauterine device).
7. Patients with the history of significant cardiovascular disorders, central nervous system disorders, endocrine disorder and other severe condition like asthma, uncontrolled hypertension and collagen disorders that may affect patient safety or difficult to evaluate the efficacy of the product.
8. Patients with clinically significant impaired renal or hepatic function [SGOT & SGPT more than 2.5X the UNL].
9. Patients with estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m2.
10. Patients with known case of Type 1 Diabetes and Type 2 Diabetes Mellitus whose diabetes has not been stable and uncontrolled for the previous three months and with HbA1c value greater than 8%.
11. Patients with a history of actively bleeding peptic ulceration or gastrointestinal bleeding.
12. Non-compliant with the study medication or any study related procedures.
13. Patients who have participated in any clinical trial in the past 3 months.
14. Patients who are known seropositive cases of HIV, Hepatitis B or Hepatitis C.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method