The efficacy and safety of a polyherbal preparation E-OA-07 was compared against placebo in patients with moderate to severe symptoms of osteoarthritis (OA) of the knee, in a double-blind, randomized, parallel groups study. Male or female subjects with American Rheumatism Association functional class II/III and Kellgren Lawrence grade 2 or 3 OA of the knee, who had moderate to severe OA symptoms as recorded by a score of at least 60 on the modified version of the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index, and an overall pain score of at least 70 mm on a 100 mm Visual analogue (VAS) scale were studied. Subjects received 2 capsules of E-OA-07 or placebo twice daily for 12 weeks and paracetamol up to 2 gm per day as rescue medication. Efficacy outcome measures were WOMAC and VAS scores, functional tests for joint mobility and gait, consumption of rescue medication, investigator's global assessment and subjects' opinion. Safety was assessed through incidence of adverse events and subject's assessment of tolerability. After 12 weeks of treatment, there was a significant reduction of WOMAC scores in the E-OA-07 group as compared with placebo (P < 0.01). Mean (±SEM) reductions in WOMAC scores of pain, stiffness, and physical function for E-OA-07 versus placebo were 8.86 (1.77) versus 2.50 (0.76), 3.00 (0.65) versus 0.75 (0.45), and 30.00 (5.22) versus 10.87 (2.18). Significant between-group differences were also observed for VAS scores of pain and stiffness. The symptom alleviating effect of E-OA-07 persisted over a follow-up period of 4 and 6 weeks as VAS pain and stiffness scores continued to remain statistically lower (P < 0.01) in the E-OA-07 group than placebo. Subject's opinion was significantly greater in favor of E-OA-07 than placebo, whereas both groups received favorable responses from investigator. Consumption of rescue medication and tolerability ratings were similar between the 2 groups. One E-OA-07 subject was hospitalized due to accidental fall and withdrawn from the study. No other serious adverse event occurred. The effect of E-OA-07 in relieving moderate to severe symptoms of OA of the knee is well tolerated, superior, and more persistent than placebo.

Background: Existing therapeutic measures for swelling, aching and discomfort in the lower limbs, which include compression stockings and leg elevation, are difficult to use and inconvenient. Patch It ® , a proprietary herbomineral patch is an easy-to-use alternative therapy. This trial was conducted to compare it's efficacy against that of a placebo in swollen and aching lower legs and feet. Methods: This randomized, placebo-controlled, double blind, crossover, sequential trial was conducted in the private clinics of physicians. A total of 100 patients (24 men and 76 women), aged 25 to 60 years, with recurring swelling in the feet and (optionally) up to two more related complaints, having an average visual analog score (VAS) of at least 60 (scale 0-100) for each complaint were recruited into the study. Patches (active or placebo) were applied to both soles overnight for 8 weeks: 4 consecutive weeks each with active or placebo in randomized sequence. Outcome measures included the average VAS score (baseline to week 4, and week 5 to week 8), preference for either patch (difference of .5 mm in average VAS score reduction), ankle figureof-eight measures, investigator's global assessment (good, fair, poor), patient's willingness to continue using the patch after the trial (yes, no), and adverse events. Results: Out of 100 patients, 86 completed the trial, while ten were excluded for noncompliance, three withdrew, and one was lost to follow-up. The active placebo boundary of the sequential chart was crossed when 82 patients completed the trial. Active patch was also superior to placebo patch by mean reductions in average VAS scores (13.14 versus 9.6, P = 0.02), mean reduction in figure-of-eight ankle measurements (1.21 cm versus 0.79 cm, P = 0.003), investigator's global assessment (P , 0.01), and by proportion of patients willing to continue using the patch after the trial (P , 0.01). Ten percent of patients experienced localized itching with each patch, but this did not require interruption of treatment. Conclusion: Patch It had greater efficacy than the placebo in alleviating recurring swelling and aching in the legs and feet, and is well tolerated.