Soft Tissue Injuries Clinical Trial
Official title:
Clinical Efficacy and Safety of Compound Methyl Salicylate Liniment in the Treatment of Acute and Chronic Soft Tissue Pain:a Multicenter, Randomized, Positive Controlled Clinical Trial
This clinical trial program was established according to the ethical principles of the Helsinki declaration and the GCP guiding principle, and a randomized grouping method was used to evaluate the efficacy and safety of Compound Methyl Salicylate Liniment in the treatment of acute and chronic soft tissue pain with a positive control drug, named Diclofenac Sodium Liniment.
This study is a randomized, double-blind, parallel controlled multicenter clinical trial for
evaluate the efficacy and safety of Compound Methyl Salicylate Liniment in the treatment of
acute and chronic soft tissue pain with a positive control drug, named Diclofenac Sodium
Liniment. A total of 216 participants with acute or chronic tissue pain participated in this
clinical trial. The clinical trial cases were equally allocated to each research center, and
each center had 30-35 cases. The proportion of patients with acute soft tissue pain and
chronic soft tissue pain was 1:1, and the proportion of the experimental group and the
control group was 1:1.The observation index include self pain scale record, tenderness scale
and swelling, the evaluation period was 7 days.
The statistical analysis plan is prepared by the unit responsible for the statistics, and is
prepared before the formal analysis of the data, and is discussed and identified at the blind
audit meeting with the major researchers. Statistical analysis will use SAS8.2 statistical
analysis software for data processing, and other statistical analysis plan to make detailed
provisions. All the statistical tests were two-sided, and the value of P was less than or
equal to 0.05, which would be considered statistically significant. Measurement data use case
number, mean, standard deviation, minimum, maximum, median and four sub spacing description,
counting data and grade data use case number, percentage description.
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