Clinical Efficacy and Safety of Compound Methyl Salicylate Liniment

NCT03362216 | Completed

• 1 other identifier: PUPH20170999
• Study Type: interventional
• Target: 216
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Soft Tissue Injuries

Keywords

soft tissue, pain

Outcome Measures

Primary Outcomes (1)

• 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.

  7 days

Secondary Outcomes (1)

• Secondary observation index

  7 days

Study Arms (2)

experimental group

EXPERIMENTAL

Treated with Compound Methyl Salicylate Liniment group

Drug: Compound Methyl Salicylate Liniment

Control group

ACTIVE COMPARATOR

Treated with Diclofenac Sodium Liniment group

Drug: Diclofenac Sodium Liniment

Interventions

Compound Methyl Salicylate Liniment DRUG

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

experimental group

Diclofenac Sodium Liniment DRUG

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

Control group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking University People's Hospital: lead

MeSH Terms

Conditions

Soft Tissue Injuries; Pain

Condition Hierarchy (Ancestors)

Wounds and Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• People's Hospital Peking University

  Peking University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dean of Peking University People's Hospital, Director of department of orthopaedic surgery of Peking University, Chairman of China trauma rescue&treatment association

Study Record Dates

• First Submitted: November 29, 2017
• First Posted: December 5, 2017
• Study Start: April 7, 2009
• Primary Completion: May 22, 2009
• Study Completion: June 12, 2009
• Last Updated: December 8, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share