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

Osteoarthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03744611
• Other study ID #: JS-CT-2018-05
• Status: Completed
• Phase: N/A
• Start date: October 22, 2018
• Est. completion date: September 5, 2019

Study information

• Verified date: July 2022
• Source: Jaseng Medical Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 5, 2019
• Est. primary completion date: September 5, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Dietary Supplement:
• CE
550mg capsule (Eucommia ulmoides Oliver extract)
• Placebo
550mg capsule (Placebo)

Locations

Country	Name	City	State
Korea, Republic of	Dongguk University Bundang Oriental Hospital	Seoul
Korea, Republic of	Kyung Hee University Korean Medicine Hospital	Seoul
Korea, Republic of	Kyung Hee University Korean Medicine Hospital at Gangdong	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Jaseng Medical Foundation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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