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Clinical Efficacy and Safety of Compound Methyl Salicylate Liniment

NCT ID: NCT03362216

Last Updated: 2017-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

216 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-07

Study Completion Date

2009-06-12

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Soft Tissue Injuries

Keywords

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soft tissue, pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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experimental group

Treated with Compound Methyl Salicylate Liniment group

Group Type EXPERIMENTAL

Compound Methyl Salicylate Liniment

Intervention Type DRUG

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

Control group

Treated with Diclofenac Sodium Liniment group

Group Type ACTIVE_COMPARATOR

Diclofenac Sodium Liniment

Intervention Type DRUG

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

Interventions

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Compound Methyl Salicylate Liniment

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

Intervention Type DRUG

Diclofenac Sodium Liniment

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

Intervention Type DRUG

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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baoguojiang

Dean of Peking University People's Hospital, Director of department of orthopaedic surgery of Peking University, Chairman of China trauma rescue&treatment association

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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People's Hospital Peking University

Role: STUDY_DIRECTOR

Peking University

Other Identifiers

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PUPH20170999

Identifier Type: -

Identifier Source: org_study_id