Clinical Efficacy and Safety of Compound Methyl Salicylate Liniment

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.

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Key information

Conditions

Soft Tissue Injuries Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Wounds and Injuries

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Compound Methyl Salicylate Liniment

Drug

Compound Methyl Salicylate Liniment, apply to the affected area, 3 times a day.Course of treatment: 7 days

Diclofenac Sodium Liniment

Drug

Diclofenac Sodium Liniment, apply to the affected area, 3 times a day. Course of treatment: 7 days

Primary outcomes

Main observation index

Time frame: 7 days

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.

Secondary outcomes

Secondary observation index

Time frame: 7 days

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.

Sponsors and collaborators

Lead sponsor

Peking University People's Hospital

Other

Registry information

Official study 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

Important dates

Study start: 2009
Primary completion: 2009
Study completion: 2009
First posted: Dec 5, 2017
Registry last updated: Dec 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed