Health Condition 1: M179- Osteoarthritis of knee, unspecified
Conditions
Interventions
Intervention1: PR/HC/1718/001
: PR/HC/1718/001
is a polyherbal formulation intended to be useful in osteoarthritis of knee.
Dose of 1 gm twice daily in 500mg divided doses for 3 months
Control Interv
Sponsors
Aayush Healthcare
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients of either sex, 40 to 70 years of age. 2. Diagnosis of OA knees , based on typical history, clinical presentation, classical radiological findings and fulfilling the ACR classification criteria for OA knees 3 Presence of typical osteophytes on skiagram knee is mandatory 4. A minimum pain VAS score > 4 on walking in one or both knees during the 24 hours preceding recruitment. 5. Patient with or without receiving regular anti â?? inflammatory or analgesic drugs, or are not satisfied with drugs being taken and seek a change. 6. Willing to come for regular follow â?? up visits. 7. Written Informed Consent from the patient.
Exclusion criteria
Exclusion criteria: 1.Patients with congenital arthropathy, rheumatoid arthritis, active gout, other type of arthritis with/without inflammation e.g. septic , fibromyalgia or collagen vascular disease 2.Patients with known history of coagulopathies 3.Osteoarthritis of any other joint except knee 4.Patients with history of major trauma or surgery in the knee joint 5.Patients with uncontrolled diabetes and hypertension 6. Body mass index (BMI) >40 kg/m2. 7.Patients with any severe cardiac, renal and hepatic disease 8.Pregnant and lactating women 9.Patients who participated in any clinical trial within 30 days before enrollment into the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment in Improvement in SF-36 Health Survey score Assessment of patients Global Assessment, Physicians global Assessment Assessment of performance of patient on pain VAS scale. Local examination, clinical signs Assessment of WOMAC Timepoint: Baseline to day 30, Day 60 and Day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of tolerability of study drug by assessing adverse events, serious adverse events during the study period. Assessment of vitals during the study period Assessment of inflammatory mediators CRP, IL-6, TNF-alphaTimepoint: Baseline to day 90 | — |
Countries
India
Contacts
Public ContactPayal Gawali
Aayush Healthcare
Outcome results
None listed