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Ids and flavans standardized to baicalin and catechin. In preclinical studies it has been shown to inhibit COX-1, COX-2 and 5-LOX and to block several animal models of inflammation [10,11]. The findings of this study suggest that a standardized composition of UP446 has an effect on pain, stiffness and physical function as evaluated by the WOMAC questionnaire.PurposeSubjects that met the inclusion/exclusion criteria were randomly assigned to 1 of the 4 study groups (Table 1).Study PopulationSubjects were ambulatory men or women, 40-75 years old and had evidence of measurable symptoms of osteoarthritis of the knee and/or hip requiring the use of acetaminophen, including COX -2 inhibitors, antiinflammatory agents or opioid analgesics as treatment medications. There were no PubMed ID:https://www.ncbi.nlm.nih.gov/pubmed/744568 significant differences between the four groups with respect to demographic characteristics (Table 2).Major inclusion criteria1. Age between 40 and 75 years; both genders admissible. 2. Evidence of measurable symptoms of osteoarthritis of the knee and/or hip requiring the use of acetaminophen, anti-inflammatory agents Methyl 2-((4-nitro-1h-pyrazol-1-yl)methyl)benzoate or opioid analgesics. 3. Patients were asked to stop use of all other "painkillers" (except acetaminophen) the week prior to initiation of the trial for washout purposes. 4. Intention to fully participate in study including attending physician appointments during trial.Major exclusion criteriaThis study was conducted to compare the effect and safety of two dosages of UP446 as compared with Celecoxib and placebo in subjects with osteoarthritis (OA) of the knee or hip.1. Patients with a history of cardiovascular or renal disease, peptic ulcer disease with or without gastrointestinal hemorrhage or perforation or uncontrolled diabetes mellitus were excluded. 2. The concomitant use of NSAIDs, including COX-2 inhibitors, H2 blockers or proton pump inhibitors was not allowed 3. Patients who had begun a new physical therapy regime within three months of screening were also excluded as were those with a history of allergy to flavonoids, NSAIDs, aspirin or acetaminophen Acetaminophen was provided as rescue medication. Subjects were permitted to take up to 1000 mg t.i.d.MeasurementsMaterials and methodsStudy designSafety was measured by physical examinations, vital signs, monthly hematology and chemistry laboratory studies, thrombin time, fecal occult blood and treatmentThis was a randomized, double blind, placebo and active comparator controlled study. The study was conducted according to ICH guidelines and under independent institutional review board oversight. An 2-Chloro-3-methoxyaniline independent review board approved the protocol and all subjects were required to provide written informed consent prior to enrollment and administration of medication or any study procedures. Study subjects were recruited bmj.i1494 from the practices of primary care physicians in Montreal, Quebec.Table 1 Subject randomizationGroup Name A0 A1 A2 A3 Dose 1 Dose 2 Dose 3 Sample size Compound PubMed ID:https://www.ncbi.nlm.nih.gov/pubmed/10811056 Dosage Placebo UP446 UP446 Celecoxib N/A (CMC capsule b.i.d) 250 mg/day (125 mg b.i.d.) 500 mg/day (250 mg b.i.d.) 200 mg/day (100 mg b.i.d.) n = 15 n = 15 n = 15 Placebo n =Acetaminophen was provided as rescue medication. Subjects were permitted to take up to 1000 mg t.i.d.Sampalis and Brownell Nutrition Journal 2012, 11:21 http://www.nutritionj.com/content/11/1/Page 3 ofTable 2 Subject demographicsUP446250 mg/day Total (N) Mean (SD) Age Male N ( ) Female N ( ) 15 62.8 (10.8) 5 (33) 10 (67) UP446500 mg/day 15 54.6 (14.8) 6 (40) 9.