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S1 File. Trial study protocol Project Initiation: the Eleventh Five-Year Scientific Support Plan of the Ministry of Science and Technology Project Title: Hypouricemic and Arthritis Relapse-reducing Effects of Compound Tufuling Oral-Liquid on Intercritical and Chronic Gout: A Double-blind, Placebo-controlled, Multicenter Randomized Trial Project Number: 2007BAI20B06 Project Director: Wen Chengping Undertaking Institute: Zhejiang University of Chinese Medicine Contact Person: Wen Chengping Contact Number: +86Study Period: Jun. 2012－Dec. 2014 I. Study Purpose To evaluate the clinical effect of Compound Tufuling Oral-liquid on the reduction of serum Uric Acid (UA) level and recurrence of acute gouty arthritis in intercritical and chronic gout. II. Design Methods and Principles (I) Study Design: randomized block design, double-blind and placebo parallel control, multi-center clinical study, superiority test (II) Sample Size: calculation formula of the sample size of measurement data by superiority test [23]: n1=[(U1-α+U1-β)σ]2δ(1+c)C (σ calculated by polled standard deviation Sc, n2 = c*n1; c=2; α=0.05, β=0.1, U1-α=1.64, U1-β=1.28; previous clinical observation showed that the decrease rate of blood UA level after TCM treatment and placebo treatment was respectively (19.37±17.74)% and (2.12±4.23)%, so σ=14.74; δ=6.8 Based on the above formula, we calculated the sample size of the treatment group and placebo group being respectively 120 and 60. Considering a 20% withdraw rate, the total sample size was decided 216. (III) Stochastic Methods: This study adopted envelope random method. With each center as a block, we use SAS software version 9.2 (SAS Institute, Cary, NC, USA) to generate randomized number for each group and each patient to decide whether they should belong to the treatment group or controlled group. (IV) Control: TCM placebo controlled (V) Masking Design: double-blind method. The researchers adjust the basic recipe according to every patient