An interventional study of Compound Methyl Salicylate Liniment and Diclofenac Sodium Liniment in Soft Tissue Injuries, sponsored by Peking University People's Hospital. Completed. Per ClinicalTrials.gov, last updated 2017-12-08.
Sponsored by Peking University People's Hospital · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
Treated with Compound Methyl Salicylate Liniment group
Drug: Compound Methyl Salicylate Liniment
Treated with Diclofenac Sodium Liniment group
Drug: Diclofenac Sodium Liniment
Compound Methyl Salicylate Liniment, apply to the affected area, 3 times a day.Course of treatment: 7 days
Diclofenac Sodium Liniment, apply to the affected area, 3 times a day. Course of treatment: 7 days
Main observation index
Self pain scale record (VAS). A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured.Operationally a VAS is usually a horizontal line, 100 mm in length, anchored by word descriptors at each end, the patient marks on the line the point that they feel represents their perception of their current state. The VAS score is determined by measuring in millimetres from the left hand end of the line to the point that the patient marks, the amount of pain that a patient feels ranges across a continuum from none to an extreme amount of pain.
Time frame: 7 days
Secondary observation index
Record of tenderness scale(VAS), Swelling. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. Operationally a VAS is usually a horizontal line, 100 mm in length, anchored by word descriptors at each end, the patient marks on the line the point that they feel represents their perception of their current state. The VAS score is determined by measuring in millimetres from the left hand end of the line to the point that the patient marks, the amount of pain that a patient feels ranges across a continuum from none to an extreme amount of pain.
Time frame: 7 days
No study locations are listed for this record.
Plan to share: No
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This study is completed, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.
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Peking University People's Hospital