Clinical Efficacy and Safety of Compound Methyl Salicylate Liniment

Peking University

Status

Completed

Conditions

Soft Tissue Injuries

Treatments

Drug: Compound Methyl Salicylate Liniment

Drug: Diclofenac Sodium Liniment

Study type

Interventional

Funder types

Other

Identifiers

NCT03362216

PUPH20170999

Details and patient eligibility

About

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.

Full description

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.

Enrollment

216 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients with various causes of acute and chronic soft tissue
Local symptoms and signs include pain, swelling, bruising, tenderness, joint dysfunction; X-ray showed no fracture, dislocation, bone tumors and bone metabolism and open injury.

Exclusion criteria

Patients who do not belong to the scope of drug use
Muscle, tendon, ligament and other soft tissue have broken completely
Accompanied by skin damage or fracture, joint dislocation, bone tumor and metabolic bone disease local tissue damage
Use of other drugs or therapies for the treatment of acute and chronic soft tissue pain after trauma
Difficult to evaluate the effectiveness and safety of new drugs
Severe hypertension, severe heart and lung dysfunction, severe arrhythmia, liver, kidney, hematopoietic system and other serious primary diseases, mental patients
Pregnant women, lactating women
Allergic constitution and allergic to the known components of the drug
Participated in other clinical trials in the past month
Use similar analgesics within a week
Other researchers considered inappropriate patients to participate in the trial