Efficacy and Safety of Cortex Eucommiae (CE: Eucommia Ulmoides Oliver Extract) in Subjects With Mild Osteoarthritis

Jaseng Medical Foundation

Status

Completed

Conditions

Osteoarthritis

Treatments

Dietary Supplement: Placebo

Dietary Supplement: CE

Study type

Interventional

Funder types

Other

Identifiers

NCT03744611

JS-CT-2018-05

Details and patient eligibility

About

The purpose of this clinical trial is to evaluate the efficacy and safety of Cortex Eucommiae (CE: Eucommia ulmoides Oliver extract) in subjects with mild osteoarthritis (OA).

Full description

This is a 12-week, multi-center, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of Cortex Eucommiae (CE: Eucommia ulmoides Oliver extract) in subjects with mild OA. One hundred subjects with mild OA will be recruited and randomly divided into 2 groups, each group will receive Cortex Eucommiae (CE: Eucommia ulmoides Oliver extract) or placebo and will take CE or placebo for 12 weeks. Outcomes will be evaluated by self-administered questionnaires and lab test results. The hypothesis is that Cortex Eucommiae (CE: Eucommia ulmoides Oliver extract) which as a dietary supplementation may slow down or reverse OA.

Enrollment

100 patients

Sex

All

Ages

40 to 75 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Male or female 40 ~ 75 years of age
VAS (Visual Analogue Scale) over 30mm
Kellgren & Lawrence Grade I~II by X-ray
Subject who agrees to participate in this clinical trial by themselves and signs the Informed Consent Form (ICF)

Exclusion criteria

Joint space under 2mm by X-ray
Kellgren & Lawrence Grade over III with osteophyte, irregularly-shaped auricular surfaces, or subchondral bone cyst by X-ray
Subjects who diagnosed inflammatory arthritis (rheumatoid arthritis, fibromyalgia, systemic lupus erythematosus, septic arthtritis, gout), or articulation fracture with abnormal values at ESR and CRP
Subjects who diagnosed cardiovascular disease, immune disease, infectious diseases, tumor diseases
Subjects having gastrointestinal diseases
Uncontrolled hypertension patients (Blood pressure ≥ 160/100mmHg)
Uncontrolled diabetes melitusl patients (fasting glucose level ≥ 180mg/dl)
Subjects have attended abnormal values at AST or ALT (3 times excess at upper limit of the normal values)
Subjects have attended abnormal values at creatinine (2 times excess at upper limit of the normal values)
Pregnancy, breast-feeding, or subjects who have a plan to pregnancy within 3 months
Use of osteoarthritis treatment drugs or dietary supplements within 2 weeks prior to screening
History of osteoarthritis treatment therapy within 2 weeks prior to screening
Psychiatric disorder patient (schizophrenia, depressive disorder, drug abuse)
Have participated in another clinical trial within the 3 months prior to screening
Subjects who have hypersensitivity history about investigational product
Have difficulty to be participated in this clinical trial by investigator's decision