Health Condition 1: S934- Sprain of ankle
Conditions
Interventions
Intervention1: FDC of Trypsin - Chymotrypsin 50000 AU plus Aceclofenac 100 mg plus Paracetamol 325 mg Tablets: Patients will be advised to take the study medication orally, swallowed as a whole with w
Sponsors
Synokem Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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) 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients reporting incidences of AE and/or SAE during the study and their assessment in respect to intensity, duration, pattern and causal relationship to the study medication.Timepoint: At Day 3, Day 7 and Day 10 | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in Laboratory Parameters (Hematology, Serum Biochemistry and Urine analysis) from baseline to end of the study.Timepoint: At Visit 1 / Day 1 and Visit 4 / Day 10;Changes in the ankle swelling & redness from baseline to end of the study.Timepoint: At Visit 1 / Day 1, Visit 2 / Day 3, Visit 3 / Day 7 and Visit 4 / Day 10;Changes in the inflammatory markers (C-reactive protein) from baseline to end of the study.Timepoint: At Visit 1 / Day 1 and Visit 4 / Day 10;Changes in Vital Signs from baseline to end of the study.Timepoint: At Visit 1 / Day 1, Visit 2 / Day 3, Visit 3 / Day 7 and Visit 4 / Day 10;Improvement in Subjects Global Assessment (SGA) and Physicians Global Assessment (PGA) at the end of the study.Timepoint: At Visit 4 / Day 10;Improvement in Visual Analog Scale (VAS) from baseline to end of the study.Timepoint: At Visit 1 / Day 1, Visit 2 / Day 3, Visit 3 / Day 7 and Visit 4 / Day 10 | — |
Countries
India
Contacts
Public ContactMr Surender Kumar Arora
Clinwave Research Pvt. Ltd.
Outcome results
None listed