MedTrace Logo

Effectiveness and Safety of Celecoxib (Celebrex 200 mg) Combined With Joins in the Treatment of Degenerative Knee Osteoarthritis: a Randomized Controlled Trial

NCT04718649 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 216

Last updated 2021-01-22

No results posted yet for this study

Summary

Osteoarthritis of the knee joint causes pain, stiffness, and restriction of joint movement in the knee joint due to degeneration of the knee cartilage. The purpose of osteoarthritis treatment is to improve the joint pain and prevent further damage to the joint. Selective Cox-2 inhibitors are the most commonly used nonsteroid anti-inflammatory drugs(NSAIDs) for the treatment of osteoarthritis of the knee joint. However, the safety of selective Cox-2 inhibitors is still controversial. Although these NSAIDs are effective in reducing pain and inflammation, they cannot be called a fundamental treatment for knee arthritis. Accordingly, interest in SYSADOA (Symptomatic Slow-acting Drugs for Osteoarthritis) is gradually increasing.

Joins is a herbal anti-arthritic drug that has various physiological activities and a new concept of osteoarthritis treatment. It has anti-inflammatory, analgesic and joint cartilage protection effects as well as fundamental treatment. Joins is used to improve articular cartilage metabolism, can delay the progression of degenerative arthritis in the knee and compensate for the disadvantages of Selective Cox-2 inhibitors. However, when the selective Cox-2 inhibitor and Joins tablet are used alone, the therapeutic effect on knee degenerative arthritis may be limited. The purpose of this study is to investigate the therapeutic effect and safety of joining together with celecoxib for degenerative arthritis of the knee joint, and to determine the degree of analgesic and anti-inflammatory effects of the combination therapy.

Conditions

Interventions

DRUG

Celebrex with Joins or not

The enrolled patienst will be divided into the group taking celecoxib 200mg with Joins tab together and the group taking celecoxib 200mg with Joins placebo in the same probability of 2:1 according to the randomization table at the first outpatient visit. Among the co-researchers, one researcher who is in charge of patient assignment will create a randomization table through computer generated randomization. And this researcher who is charge of the patient assignment will not intervene in any other process of this study, and only participates in the task of selecting the assigned group using random checks. The evaluation will be evaluated by an researcher who is not aware of the patient allocation according to the randomization table among researchers participating in the clinical study

Sponsors & Collaborators

  • SK Chemicals Co., Ltd.

    collaborator INDUSTRY

  • The Catholic University of Korea

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-31
Primary Completion
2022-12-31
Completion
2022-12-31

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04718649 on ClinicalTrials.gov