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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03744611
Recruitment Status : Completed
First Posted : November 16, 2018
Last Update Posted : November 8, 2019
Sponsor:
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Osteoarthritis Dietary Supplement: CE Dietary Supplement: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : October 22, 2018
Actual Primary Completion Date : September 5, 2019
Actual Study Completion Date : September 5, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: 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)




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03744611


Locations
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Korea, Republic of
Kyung Hee University Korean Medicine Hospital
Seoul, Korea, Republic of, 02447
Kyung Hee University Korean Medicine Hospital at Gangdong
Seoul, Korea, Republic of, 05278
Dongguk University Bundang Oriental Hospital
Seoul, Korea, Republic of, 13601
Sponsors and Collaborators
Jaseng Medical Foundation
Investigators
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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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jaseng Medical Foundation
ClinicalTrials.gov Identifier: NCT03744611    
Other Study ID Numbers: JS-CT-2018-05
First Posted: November 16, 2018    Key Record Dates
Last Update Posted: November 8, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jaseng Medical Foundation:
Cortex Eucommiae (CE: Eucommia ulmoides Oliver extract), mild OA
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases