OsteoarthritisNCT03744611
Efficacy and Safety of Cortex Eucommiae (CE: Eucommia Ulmoides Oliver Extract) in Subjects With Mild Osteoarthritis
A study testing CE in people with Osteoarthritis, run by Jaseng Medical Foundation at 3 sites in South Korea.
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). Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- CE
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 3 sitesSouth Korea
- Study dates
- 22 Oct 2018to 5 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Show all 16Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
South Korea3 sites
Kyung Hee University Korean Medicine Hospital
Seoul, 02447
Kyung Hee University Korean Medicine Hospital at Gangdong
Seoul, 05278
Dongguk University Bundang Oriental Hospital
Seoul, 13601
About this study
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
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).
Read the 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.
- Conditions
- Osteoarthritis
- Being tested
- CE, Placebo
- Keywords
- Cortex Eucommiae, mild OA
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CEDietary supplement
550mg capsule (Eucommia ulmoides Oliver extract)
PlaceboDietary supplement
550mg capsule (Placebo)
| Study group | Role | What they receive |
|---|---|---|
| Cortex Eucommiae(CE) | Experimental | CE capsule administered orally twice daily for 12 weeks. Receives: Dietary Supplement: CE |
| Placebo | Placebo comparator | Placebo capsule administered orally twice daily for 12 weeks. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS (Visual Analogue Scale)
VAS to measure changes in joint pain on 6, 12 weeks after administration in comparison with baseline
Measured: 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
Measured: 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
Measured: Change of the week 6, 12 from baseline
Secondary outcomes (4)
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
Measured: 6 weeks, 12 weeks
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
Measured: 6 weeks, 12 weeks
ESR (Erythrocyte sedimentation rate)
ESR to measure changes in blood inflammatory marker on 12 weeks after administration in comparison with baseline
Measured: Change of the week 12 from baseline
CRP (C-reactive protein)
CRP to measure changes in blood inflammatory marker on 12 weeks after administration in comparison with baseline
Measured: Change of the week 12 from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2018
- Study start22 Oct 2018
- Primary completion5 Sep 2019
- Study completion5 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jaseng Medical Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hyeon Yeong Ahn, PhD, Study director, Jaseng Medical FoundationJae-Heung Cho, KMD,PhD, Principal investigator, Kyung Hee University at GangdongDongwoo Nam, KMD,PhD, Principal investigator, Kyunghee UniversityEun-Jung Kim, KMD,PhD, Principal investigator, DongGuk UniversityIn-Hyuk Ha, KMD,PhD, Study chair, Jaseng Medical Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03744611
- Sponsor's protocol ID
- JS-CT-2018-05
- Status last verified
- Jul 2022
- First submitted
- 12 Nov 2018
- Last updated
- 25 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 31852118
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03744611
- Acronym / sponsor ID
- JS-CT-2018-05
- Conditions
- Osteoarthritis
- Keywords
- Cortex Eucommiae, mild OA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Jaseng Medical FoundationUniversity, hospital or other
- Study start
- 22 Oct 2018 (actual)
- Primary completion
- 5 Sep 2019 (actual)
- Study completion
- 5 Sep 2019 (actual)
- First posted
- 16 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cortex Eucommiae(CE) | Experimental | Dietary Supplement: CECE capsule administered orally twice daily for 12 weeks. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo capsule administered orally twice daily for 12 weeks. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CE550mg capsule (Eucommia ulmoides Oliver extract) | Dietary supplement | Cortex Eucommiae(CE) |
| Placebo550mg capsule (Placebo) | Dietary supplement | Placebo |
Primary outcome
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
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
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
4 secondary outcomes
Subject's global impression of change scale
Time frame: 6 weeks, 12 weeks
Investigator's global impression of change scale
Time frame: 6 weeks, 12 weeks
ESR (Erythrocyte sedimentation rate)
Time frame: Change of the week 12 from baseline
CRP (C-reactive protein)
Time frame: Change of the week 12 from baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2022.
- Derived from this study: PubMed 31852118Ahn 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.
- Individual participant dataSharing planned: Undecided
Related trials for Osteoarthritis
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Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hyeon Yeong Ahn, PhD study director
Jaseng Medical Foundation
Jae-Heung Cho, KMD,PhD principal investigator
Kyung Hee University at Gangdong
Dongwoo Nam, KMD,PhD principal investigator
Kyunghee University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CE in people with Osteoarthritis, run by Jaseng Medical Foundation at 3 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS (Visual Analogue Scale) (time frame: Change of the week 6, 12 from baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03744611, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2022.