Health Condition 1: S934- Sprain of ankle
Conditions
Interventions
Intervention1: FDC of Trypsin ââ?¬â?? Chymotrypsin 50000 AU plus Bromelain 90 mg plus Rutoside Trihydrate 100 mg Tablets: Patients will be advised to take the study medication orally, swallowed as a
Sponsors
Synokem Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female patients aged between 18 to 65 (both inclusive) years. 2. Patients with conditions associated with Inflammation and edema of traumatic origin such as Ankle sprain or Sport injuries or Tendinitis or Post-surgery of tooth extraction. 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 (including clinical chemistry, hematology and complete urinalysis) are not within the reference range for the testing laboratory and the results are deemed clinically significant by the investigator. 3. Patients treated with other analgesic (NSAIDS, Opioids and Corticosteroids) medications 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, hepatic impairment, renal impairment and other severe condition like asthma, uncontrolled hypertension, collagen disorders, severe infection etc. or any other medical illness 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 and 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.
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: Throughout the Study | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in Laboratory Safety Parameters (Hematology, Serum Biochemistry and Urine analysis) from baseline to end of the study.Timepoint: At Baseline and Day 7;Changes in Vital Signs from baseline to end of the study.Timepoint: At Baseline, Day 3 and Day 7;Improvement in Subjects Global Assessment (SGA) and Physicians Global Assessment (PGA) at the end of the study.Timepoint: At Day 7;Improvement in Visual Analog Scale (VAS) from baseline to end of the study.Timepoint: At Baseline, Day 3 and Day 7 | — |
Countries
India
Contacts
Public ContactMr Surender Kumar Arora
Clinwave Research Pvt. Ltd.
Outcome results
None listed