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

Not Applicable

Completed

• Conditions: Osteoarthritis
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: CE

• Registration Number: NCT03744611
• Lead Sponsor: Jaseng Medical Foundation

Brief Summary

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).

Detailed 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.

Study Timeline

• Study Start: 2018-10-22
• Study First Submitted: 2018-11-12
• Study First Submitted QC: 2018-11-14
• Study First Posted: 2018-11-16
• Primary Completion: 2019-09-05
• Study Completion: 2019-09-05
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-21
• Last Update Posted: 2022-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo capsule administered orally twice daily for 12 weeks.
Cortex Eucommiae(CE)	CE	CE capsule administered orally twice daily for 12 weeks.

Primary Outcome Measures

Name	Time	Method
KSF-36 (Korean-Short Form Health Survey 36)	Change of the week 6, 12 from baseline	KSF-36 to measure changes in physical and mental function on 6, 12 weeks after administration in comparison with baseline
VAS (Visual Analogue Scale)	Change of the week 6, 12 from baseline	VAS to measure changes in joint pain on 6, 12 weeks after administration in comparison with baseline
K-WOMAC (Korean-Western Ontario and McMaster Universities)	Change of the week 6, 12 from baseline	K-WOMAC to measure changes in joint pain and function on 6, 12 weeks after administration in comparison with baseline

Secondary Outcome Measures

Name	Time	Method
Subject's global impression of change scale	6 weeks, 12 weeks	The change in activity limitations, symptoms, emotions and overall quality of life, related to painful condition that is assessed by subject; Level of Quality; * Excellent: substantial overall improvement of symptoms; * Good: overall improvement of symptoms; * Neutral: no change compared with before; * Worse: overall deterioration of symptoms; * Very much worse: substantial overall deterioration of symptoms
Investigator's global impression of change scale	6 weeks, 12 weeks	The change in activity limitations, symptoms, emotions and overall quality of life, related to painful condition that is assessed by investigator; Level of Quality; * Excellent: substantial overall improvement of symptoms; * Good: overall improvement of symptoms; * Neutral: no change compared with before; * Worse: overall deterioration of symptoms; * Very much worse: substantial overall deterioration of symptoms
CRP (C-reactive protein)	Change of the week 12 from baseline	CRP to measure changes in blood inflammatory marker on 12 weeks after administration in comparison with baseline
ESR (Erythrocyte sedimentation rate)	Change of the week 12 from baseline	ESR to measure changes in blood inflammatory marker on 12 weeks after administration in comparison with baseline

Trial Locations

Locations (3)

Kyung Hee University Korean Medicine Hospital; 🇰🇷 Seoul, Korea, Republic of

Kyung Hee University Korean Medicine Hospital at Gangdong; 🇰🇷 Seoul, Korea, Republic of

Dongguk University Bundang Oriental Hospital; 🇰🇷 Seoul, Korea, Republic of