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

July 21, 2022 updated by: Jaseng Medical Foundation

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
VAS (Visual Analogue Scale)
Time Frame: 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
Change of the week 6, 12 from baseline
K-WOMAC (Korean-Western Ontario and McMaster Universities)
Time Frame: 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
Change of the week 6, 12 from baseline
KSF-36 (Korean-Short Form Health Survey 36)
Time Frame: 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
Change of the week 6, 12 from baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
ESR (Erythrocyte sedimentation rate)
Time Frame: Change of the week 12 from baseline
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)
Time Frame: Change of the week 12 from baseline
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
Time Frame: 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
6 weeks, 12 weeks
Investigator's global impression of change scale
Time Frame: 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
6 weeks, 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jaseng Medical Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 22, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 5, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 5, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 12, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 14, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 16, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 25, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 21, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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