Clinical trial NCT03744611: Efficacy and Safety of Cortex Eucommiae (CE: Eucommia Ulmoides Oliver Extract) in Subjects With Mild Osteoarthritis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Keywords: Cortex Eucommiae
mild OA
Lead sponsor: Jaseng Medical Foundation
Sponsor class: OTHER
First posted: 2018-11-16
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: VAS (Visual Analogue Scale)
timeFrame: Change of the week 6, 12 from baseline
measure: K-WOMAC (Korean-Western Ontario and McMaster Universities)
timeFrame: Change of the week 6, 12 from baseline
measure: KSF-36 (Korean-Short Form Health Survey 36)
timeFrame: Change of the week 6, 12 from baseline
Secondary outcomes:
measure: Subject's global impression of change scale
timeFrame: 6 weeks, 12 weeks
measure: Investigator's global impression of change scale
timeFrame: 6 weeks, 12 weeks
measure: ESR (Erythrocyte sedimentation rate)
timeFrame: Change of the week 12 from baseline
measure: CRP (C-reactive protein)
timeFrame: Change of the week 12 from baseline
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Korean Medicine Hospital
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Korean Medicine Hospital at Gangdong
city: Seoul
country: Korea, Republic of
facility: Dongguk University Bundang Oriental Hospital
Study officials:
affiliation: Jaseng Medical Foundation
name: Hyeon Yeong Ahn, PhD
role: STUDY_DIRECTOR
affiliation: Kyung Hee University at Gangdong
name: Jae-Heung Cho, KMD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kyunghee University
name: Dongwoo Nam, KMD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: DongGuk University
name: Eun-Jung Kim, KMD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Jaseng Medical Foundation
name: In-Hyuk Ha, KMD,PhD
role: STUDY_CHAIR
References:
citation: 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.