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

Efficacy and Safety of Cortex Eucommiae (CE: Eucommia Ulmoides Oliver Extract) in Subjects With Mild Osteoarthritis: a 12-week, Multi-center, Randomized, Double-blind, Placebo-controlled Trial

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).

Study Overview

• Status: Completed
• Conditions: Osteoarthritis
• Intervention / Treatment: Dietary supplement: CE; Dietary supplement: Placebo

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 02447
    • Kyung Hee University Korean Medicine Hospital
  • Seoul, Korea, Republic of, 05278
    • Kyung Hee University Korean Medicine Hospital at Gangdong
  • Seoul, Korea, Republic of, 13601
    • Dongguk University Bundang Oriental Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cortex Eucommiae(CE); CE capsule administered orally twice daily for 12 weeks.	Dietary supplement: CE; 550mg capsule (Eucommia ulmoides Oliver extract)
Placebo Comparator: Placebo; Placebo capsule administered orally twice daily for 12 weeks.	Dietary supplement: Placebo; 550mg capsule (Placebo)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ESR (Erythrocyte sedimentation rate)	ESR to measure changes in blood inflammatory marker on 12 weeks after administration in comparison with baseline	Change of the week 12 from baseline
CRP (C-reactive protein)	CRP to measure changes in blood inflammatory marker on 12 weeks after administration in comparison with baseline	Change of the week 12 from baseline
Subject's global impression of change scale	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	6 weeks, 12 weeks
Investigator's global impression of change scale	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	6 weeks, 12 weeks

Collaborators and Investigators

• Sponsor: Jaseng Medical Foundation
• Investigators: Study Director: Hyeon Yeong Ahn, PhD, Jaseng Medical Foundation; Principal Investigator: Jae-Heung Cho, KMD,PhD, Kyung Hee University at Gangdong; Principal Investigator: Dongwoo Nam, KMD,PhD, Kyunghee University; Principal Investigator: Eun-Jung Kim, KMD,PhD, Dongguk University; Study Chair: In-Hyuk Ha, KMD,PhD, Jaseng Medical Foundation

Publications and helpful links

General Publications

• Ahn HY, Cho JH, Nam D, Kim EJ, Ha IH. Efficacy and safety of Cortex Eucommiae (Eucommia ulmoides Oliver) extract in subjects with mild osteoarthritis: Study protocol for a 12-week, multicenter, randomized, double-blind, placebo-controlled trial. Medicine (Baltimore). 2019 Dec;98(50):e18318. doi: 10.1097/MD.0000000000018318.

Study record dates

Study Major Dates

• Study Start (Actual): October 22, 2018
• Primary Completion (Actual): September 5, 2019
• Study Completion (Actual): September 5, 2019

Study Registration Dates

• First Submitted: November 12, 2018
• First Submitted That Met QC Criteria: November 14, 2018
• First Posted (Actual): November 16, 2018

Study Record Updates

• Last Update Posted (Actual): July 25, 2022
• Last Update Submitted That Met QC Criteria: July 21, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Cortex Eucommiae; mild OA
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: JS-CT-2018-05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No