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Abstract 992AIM:to study the efficacy and safety of RA 11 in patients with osteoarthritis (OA) knees. RA 11, a standardised multiple plant-based formulation has been evaluated in RA (Arth Rheum 1996; 39, 9:S283);Ayurvedic system used similar drugs to treat many forms of arthritis.METHOD:90 patients (pts) with symptomatic primary OA knees (pain VAS > 4cm at least one knee post analgesic wash-out), were enrolled into a randomised, double blind, placebo controlled, parallel-efficacy 32 week (wk) drug trial (80% power to detect 25% difference, a=0.05; 2-sided), followed by an ongoing OLP (open label phase). No concurrent analgesics, NSAIDs-oral/local, & intra-articular steroids were allowed; no diet restrictions advised. Pain VAS (recorded in each knee) and WOMAC (Western Ontario McMaster Univ OA Index, ver likert 3.0, modified-validated for Indian customs) were 'primary efficacy variables' (PEV). Lab monitoring done; XRay knee at baseline. Weekly change rate (WCR) in PEV between gp was compared by a mixed model ANOVA (fixed baseline, time & treatment time effects; with weighted data from withdrawn patients). On withdrawl (wdl) pts in OLP assessed for poor drug efficacy (PDE) (pts global improve < 70% baseline + pain VAS > 3cm any knee of 16 wk prior wtdl) The group (gp) [active (act)=45, placebo (plb)=45] were well matched at baseline for several demographic and efficacy measures (mean VAS act=6.17; plb=6.5).RESULTS:(i) The act of gp showed a greater reduction in the WCR for pain VAS (p=0.006) and WOMAC [combined (p=0.04), pain (p=0.06), stiffness (p=0.01), difficulty (p=0.06)]. Vs plb, act gp improved (p<0.05) in PEV for mean change from baseline to wk 16 and wk 32 endpoints. (ii)major side-effects were conspicuously absent; No differences between the gps (chi p>0.05) (iii)By wk 78, 18 pts (random phase=9 pts) had wdl due to PDE in the act gp; none ever due to drug toxicity (iv) 24 hour urinary cortisol vaues (to detect any steroid compound/effect in RA 11) did not differ between the gp at baseline and wk 16 endpoint (p=0.7).CONCLUSION:RA 11 is a safe and effective drug in the long term treatment of OA knees. Besides symptomatic relief, it should be investigated for a possible chondroprotective effect.Disclosure: work reported in this abstract was supported by: THIS STUDY WAS FUNDED BY AYURCORE INC., USA

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