Health Condition 1: M15-M19- Osteoarthritis
Conditions
Interventions
Intervention1: Enzomac: Dose- FDC of Trypsin + Bromelain + Rutoside trihydrate,
Frequency-BID (Twice a day),
Route of administration- Oral,
Duration of therapy-28 Days
Control Intervention1: Rejoint
Sponsors
Dr Aniket Nitinkumar Shah
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or non-pregnant female aged more than or equal to 35 years 2. Clinical diagnosis of OA knee according to the American College of Rheumatology (ACR) criteria; including Knee pain and at least three of following criteria prior to screening: - Age more than 50 years - Morning stiffness less than 30 minutes - Crepitus on active motion - Bony tenderness - Bony enlargement - No palpable warmth of synovium 3. Symptoms in knee for at least 6 months prior to screening 4. Knee pain for 15 days of the preceding month (periarticular knee pain due to OA and not due to other conditions such as bursitis, tendonitis, etc.) 5. Had an X-ray of knee, taken no more than 1 year before baseline, showing evidence of OA with Kellgren-Lawrence Grade 1-3 disease 6. Ability to replace all current pain medications with paracetamol for use as needed throughout the study (patients should be able to withhold rescue medication (paracetamol) use for at least 24 hours prior to VAS pain score assessment at study visits) 7. If female and of child-bearing potential, must be willing to consistently use appropriate method of contraception throughout the study 8. Willing to comply with all aspects of study protocol 9. Willing to provide written informed consent for the trial
Exclusion criteria
Exclusion criteria: 1. Patients with known hypersensitivity to active ingredients or inactive ingredients of the study treatment. 2. Patients with known HIV infections. 3. Concomitant use of corticosteroids (any formulation) or use within 30 days of randomization. 4. Patients with impaired liver function, defined as SGOT 2.0 times the upper limit of normal. 5. Patients with impaired kidney function, confirmed by serum creatinine >2.0 mg/dl. 6. Patients with presence of active peptic ulcer or any other disease affecting the absorption of drug history of gastrointestinal bleeding (hematemesis or malena). 7. Patients with inflammatory arthritis and other types of arthritis 8. Patients with diabetes mellitus 9. Patients who have history of recent knee injury 10. Patients suffering from hematologic or endocrine disorders. 11. On clinical examination following has to be ruled out like instability problem, nerve root signs, radiculopathy and postural problem. 12. Female patients who are pregnant or lactating or planning to be pregnant. 13. History of drug/substance abuse 14. History of secondary OA (e.g. congenital, traumatic, gouty arthritis), rheumatoid arthritis, chronic inflammatory disease (e.g. colitis) or fibromyalgia 15. Receiving physical therapy for current condition of osteoarthritis of knee. 16. Evidence or history of clinically significant medical or surgical abnormality including clinically significant laboratory parameters that, in the opinion of the investigator, would put the patient at risk through study period, or would affect the study analyses if the disease exacerbates during the study. 17. Any other condition that, in the opinion of the investigator, does not justify the inclusion of the patient in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Visual Analogue Scale Score from baseline in all treatment groups on Day 29Timepoint: Day 29 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Visual Analogue Scale Score from baseline in all treatment groups on Day 15Timepoint: Day 15 | — |
Countries
India
Contacts
Public ContactDr Aniket Nitinkumar Shah
Chopda Medicare and Research Centre Pvt. Ltd.
Outcome results
None listed