Health Condition 1: null- Osteoarthritis of Knee(s)
Conditions
Interventions
Intervention1: AHPL/AYTAB/0313 Tablet: Each film coated tablet contains extracts of Shallaki (Boswellia serrata), Guggulu (Commiphora mukul), Rasna (Pluchea lanceolata), Ashvagandha (Withania somnifer
Sponsors
Ari Healthcare Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Subject willing to participate, who have read, understood and signed informed consent form 2.Subject with history of knee pain due to osteoarthritis requiring use of NSAIDs acetaminophen, or another analgesic agent on a regular basis (greater than or equal to 3 days per week) for at least 6 months before the screening visit. 3.OA confirmed by radiographs and diagnosed according to ACR diagnostic criteria (clinical and radiological) for the OA of the knee. 4.Subjects are willing to make all required study visits 5.Subjects are willing to follow study instructions given by the investigator
Exclusion criteria
Exclusion criteria: 1.Subjects refused to give their informed consent 2.Subjects with rheumatoid arthritis, gout, pseudo gout, inflammatory arthritis, Pagets disease of bone, chronic pain syndrome, fibromyalgia, or another major joint disease 3.Subjects with history of surgery, including arthroscopy, or major trauma to the study joint in the previous six months before the screening visit 4.Subjects requiring knee arthroplasty within 6 months of screening or anticipating any need for a surgical procedure on the index joint during the study 5.Subjects with signs of clinically important active inflammation of the study knee joint including redness, warmth and or a large, bulging effusion with the loss of normal contour at the screening and or baseline visits 6.Subjects using systemic corticosteroids within 2 months of screening, or intraarticular visco-supplementation within the past 3 months 7.Subjects with any other investigational drug within 1 month prior to randomization; 8.Subjects having diabetes mellitus, tuberculosis, HIV, ischemic heart disease 9.Subjects with known major medical or surgical disease 10.Pregnant and lactating women 11.Subjects with known hypersensitivity to ingredients used in study drug. 12.Subjects with significant abnormal laboratory parameters 13.ECG demonstrating any signs of uncontrolled arrhythmia and or acute ischemia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of efficacy of AHPL/AYTAB/0313 tablet by assessing knee joint pain on VAS and by assessment of WOMAC IndexTimepoint: Screening Visit (day -7), Baseline Visit (day 0), Visit 1 (day 30), Visit 2 (day 60), Visit 3 (day 90), Visit 4 (day 120), Visit 5 (day 150) and Visit 6 (day 180). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Quality of life on SF -36 questionnaire 2.Time to walk 50 feet on even surface 3.Knee joint swelling on graded scale 4.Global assessment for overall improvement by the subject and investigator at the end of 180 days of study treatment 5.Use of analgesic drug as rescue medicine 6.Tolerability of the study drug evaluated by number of Adverse Drug Reactions 7.Safety laboratory investigations Timepoint: Screening Visit (day -7), Baseline Visit (day 0), Visit 1 (day 30), Visit 2 (day 60), Visit 3 (day 90), Visit 4 (day 120), Visit 5 (day 150) and Visit 6 (day 180). | — |
Countries
India
Contacts
Public ContactDr Sanjay Nipanikar
Ari Healthcare Pvt. Ltd.
Outcome results
None listed