RecruitingPhase 2NCT06954766

Initial Pilot Study to Evaluate the Safety and Temporary Symptom Improvement Efficacy of CKD-981

A Randomized, Double-blind, Sham-controlled, Initial Pilot Study to Evaluate the Safety and Temporary Symptom Improvement Efficacy of CKD-981 in Patients With Degenerative Knee Osteoarthritis


Sponsor

Chong Kun Dang Pharmaceutical

Enrollment

100 participants

Start Date

May 12, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to prove that the temporary symptom improvement effect on knee osteoarthritis using CKD-981


Eligibility

Min Age: 40 YearsMax Age: 80 Years

Inclusion Criteria4

  • Patients between 40 years and 80 years old
  • Patients who have experiencing knee pain more than 8 weeks
  • VAS more than 40 mm
  • Kellgren and Lawrence grade 2 and 3 in X' ray knee joint

Exclusion Criteria4

  • Previous knee surgery in affected side
  • Patients with Rheumatoid arthritis, connective tissue disease, Paget's disease
  • Infection of knee joint
  • BMI more than 35kg/m2

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Interventions

DEVICECKD-981(1)

20 minutes per day, 5 days a week for 6 weeks.

DEVICECKD-981(2)

20 minutes per day, 5 days a week for 6 weeks.

DEVICESham device

20 minutes per day, 5 days a week for 6 weeks.

DRUGReference Drug

QD for 6 weeks

DRUGPlacebo Drug

QD for 6 weeks


Locations(1)

Wonju Severance Christian Hospital

Wŏnju, South Korea

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NCT06954766


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