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

NCT03744611 | Completed

• 1 other identifier: JS-CT-2018-05
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 3

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).

Conditions

Osteoarthritis

Keywords

Cortex Eucommiae; mild OA

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Subject's global impression of change scale

  6 weeks, 12 weeks

• Investigator's global impression of change scale

  6 weeks, 12 weeks

• ESR (Erythrocyte sedimentation rate)

  Change of the week 12 from baseline

• CRP (C-reactive protein)

  Change of the week 12 from baseline

Study Arms (2)

Cortex Eucommiae(CE)

EXPERIMENTAL

CE capsule administered orally twice daily for 12 weeks.

Dietary Supplement: CE

Placebo

PLACEBO COMPARATOR

Placebo capsule administered orally twice daily for 12 weeks.

Dietary Supplement: Placebo

Interventions

CE DIETARY_SUPPLEMENT

550mg capsule (Eucommia ulmoides Oliver extract)

Cortex Eucommiae(CE)

Placebo DIETARY_SUPPLEMENT

550mg capsule (Placebo)

Placebo

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Jaseng Medical Foundation: lead

Study Sites (3)

Kyung Hee University Korean Medicine Hospital

Seoul, 02447, South Korea

Location

Kyung Hee University Korean Medicine Hospital at Gangdong

Seoul, 05278, South Korea

Location

Dongguk University Bundang Oriental Hospital

Seoul, 13601, South Korea

Location

Related Publications (1)

• 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.

  PMID: 31852118 DERIVED

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Hyeon Yeong Ahn, PhD

  Jaseng Medical Foundation

  STUDY DIRECTOR

• 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

  PRINCIPAL INVESTIGATOR

• In-Hyuk Ha, KMD,PhD

  Jaseng Medical Foundation

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2018
• First Posted: November 16, 2018
• Study Start: October 22, 2018
• Primary Completion: September 5, 2019
• Study Completion: September 5, 2019
• Last Updated: July 25, 2022

Record last verified: 2022-07

Locations

KR (3)