Mild Knee OsteoarthritisPhase 2/3NCT01472822
Efficacy of Omija (Schisandra Chinensis) Extract in Subjects With Knee Osteoarthritis
A Phase 2/3 study testing Omija extract. in people with Mild Knee Osteoarthritis, run by Chonbuk National University Hospital at 1 site in South Korea.
Trial summary
Knee osteoarthritis (KO) is a common arthropathy and a leading cause of disability in elderly adults. Schizandra chinensis(Omija) has been known to have five predominant tastes: salty, sweet, sour, astringent, and bitter. Read more about this study
- Who is it for?
- Ages 30 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Mild Knee Osteoarthritis
- What is being tested?
- Omija extract.
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2011to Dec 2011
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 30 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males and females 30-70 years old
- mild to Moderate KO(Knee Osteoarthritis) as indicated by WOMAC(Western Ontario and McMaster University Osteoarthritis Index) score ≥ 38
- Able to walk
- Subject agrees not to start any new therapies for OA during the course of the study
- Able to give informed consent
Who cannot join
- History of underlying inflammatory arthropathy; septic arthritis; inflammatory joint disease; gout; pseudogout; Paget's disease; joint fracture; acromegaly; fibromyalgia; Wilson's disease; ochronosis; haemochromatosis; heritable arthritic disorder or collagen gene mutations or rheumatoid arthritis
- Expectation of surgery in the next 4 months
- Recent injury in the area affected by OA of the knee, i.e. meniscal tear (past 4 months)
- Cartilage reconstruction procedure in the target knee
- Intra-articular corticosteroid injections in the target knee within the last 3 months
- Viscous injections in the target knee within the last 6 months
- Abnormal liver or kidney function tests (ALT or AST > 2 times the upper limit of normal; elevated creatinine, males>125 umol/L, females>110 umol/L)
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Clinical Trial Center for Functional Foods; Chonbuk National University Hospital
Jeonju, Jeollabuk-do, 560-822
About this study
Official title: Efficacy and Safety of Omija Extract on Gonarthritis
Knee osteoarthritis (KO) is a common arthropathy and a leading cause of disability in elderly adults. Schizandra chinensis(Omija) has been known to have five predominant tastes: salty, sweet, sour, astringent, and bitter. It has also been shown to have various effects on the anti-inflammatory, cardiovascular system, gastrointestinal system, central nervous system, endocrine system, and stress protect. Therefore, this study is designed to evaluate the efficacy and safety on KO of Omija extract.
Read the detailed description
In the present study, the investigators will assess the efficacy and safety of the formulation of Omija extract(1,200 mg administered twice a day) on the symptoms of knee osteoarthritis (KO) during a 12-week treatment course. In a randomized, double-blind placebo-controlled trial, subjects will be randomly assign to receive oral omija treatment group(n=30) or placebo group(n=30). The primary efficacy outcome measure will be score change in the WOMAC(Western Ontario and McMaster University Osteoarthritis Index) after 12-weeks. Secondary parameters will be included the Lysholm index score, hs-CRP, osteocalcin(OSC), and deoxypyridinoline(DPYR).
- Conditions
- Mild Knee Osteoarthritis
- Being tested
- Omija extract., Placebo
- Keywords
- Omija, knee osteoarthritis
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omija extract.Dietary supplement
Omija extract 1.2g/day for 12weeks
PlaceboDietary supplement
Placebo 1.2g/day for 12weeks
| Study group | Role | What they receive |
|---|---|---|
| Omija extract. | Experimental | Not described Receives: Dietary Supplement: Omija extract. |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in WOMAC (Western Ontario and McMaster University Osteoarthritis Index) Totol Score
WOMAC(Western Ontario and McMaster University Osteoarthritis Index) total score (score 0-96) was measured in study visit 1(0 week) and visit 3(12 week).
The original index consists of 24 Questions. Individual question response is assigned a score of between 0 (none) to 4 (extreme) and summed to form a score ranging from 0 (best) to 96 (worst).
Measured: 12 weeks
Secondary outcomes (4)
Changes in Lysholm Index Score
Lysholm index score total score (score 0-100) was measured in study visit 1(0 week) and visit 3(12 week).
The original index consists of 9 Questions(Limp, Assive devices, Up stair, Giving way, Sauat, Sit down\&up, Cripitation, Swelling, Pain). Lysholm index score total score summed to form a score ranging from 0 (worst) to 100 (best).
Measured: 12 weeks
Changes in Hs-CRP(High Sensitivity C-reactive Protein)
hs-CRP(high sensitivity C-reactive protein) was measured in study visit 1(0 week) and visit 3(12 week).
Measured: 12 weeks
Changes in OSC(Osteocalcin)
OSC(Osteocalcin) was measured in study visit 1(0 week) and visit 3(12 week).
Measured: 12 weeks
Changes in DPD(Deoxypyridinoline)
DPD(Deoxypyridinoline) was measured in study visit 1(0 week) and visit 3(12 week).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2011 (estimated)
- Study startMar 2011
- Primary completionJun 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Mild Knee 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chonbuk National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Soo-Wan Chae, Chonbuk National University Hospital
- Investigators
- Jeong-Hwan Seo, MD, Principal investigator, Chonbuk National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01472822
- Sponsor's protocol ID
- BIOYD-KA-SCHISANDRA
- Status last verified
- Dec 2012
- First submitted
- 14 Nov 2011
- Last updated
- 4 Feb 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Omija Extract on Gonarthritis
- ClinicalTrials.gov ID
- NCT01472822
- Acronym / sponsor ID
- BIOYD-KA-SCHISANDRA
- Conditions
- Mild Knee Osteoarthritis
- Keywords
- Omija, knee osteoarthritis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Chonbuk National University HospitalUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Jun 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 17 Nov 2011 (estimated)
- Results
- Posted 4 Feb 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Knee osteoarthritis (KO) is a common arthropathy and a leading cause of disability in elderly adults. Schizandra chinensis(Omija) has been known to have five predominant tastes: salty, sweet, sour, astringent, and bitter. It has also been shown to have various effects on the anti-inflammatory, cardiovascular system, gastrointestinal system, central nervous system, endocrine system, and stress protect. Therefore, this study is designed to evaluate the efficacy and safety on KO of Omija extract.
Detailed description
In the present study, the investigators will assess the efficacy and safety of the formulation of Omija extract(1,200 mg administered twice a day) on the symptoms of knee osteoarthritis (KO) during a 12-week treatment course. In a randomized, double-blind placebo-controlled trial, subjects will be randomly assign to receive oral omija treatment group(n=30) or placebo group(n=30). The primary efficacy outcome measure will be score change in the WOMAC(Western Ontario and McMaster University Osteoarthritis Index) after 12-weeks. Secondary parameters will be included the Lysholm index score, hs-CRP, osteocalcin(OSC), and deoxypyridinoline(DPYR).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Omija extract. | Experimental | Dietary Supplement: Omija extract. |
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Males and females 30-70 years old
- mild to Moderate KO(Knee Osteoarthritis) as indicated by WOMAC(Western Ontario and McMaster University Osteoarthritis Index) score ≥ 38
- Able to walk
- Subject agrees not to start any new therapies for OA during the course of the study
- Able to give informed consent
Key exclusion criteria (7 listed)
- History of underlying inflammatory arthropathy; septic arthritis; inflammatory joint disease; gout; pseudogout; Paget's disease; joint fracture; acromegaly; fibromyalgia; Wilson's disease; ochronosis; haemochromatosis; heritable arthritic disorder or collagen gene mutations or rheumatoid arthritis
- Expectation of surgery in the next 4 months
- Recent injury in the area affected by OA of the knee, i.e. meniscal tear (past 4 months)
- Cartilage reconstruction procedure in the target knee
- Intra-articular corticosteroid injections in the target knee within the last 3 months
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 |
|---|---|---|
| Omija extract.Omija extract 1.2g/day for 12weeks | Dietary supplement | Omija extract. |
| PlaceboPlacebo 1.2g/day for 12weeks | Dietary supplement | Placebo |
Primary outcome
Changes in WOMAC (Western Ontario and McMaster University Osteoarthritis Index) Totol Score
Time frame: 12 weeks
WOMAC(Western Ontario and McMaster University Osteoarthritis Index) total score (score 0-96) was measured in study visit 1(0 week) and visit 3(12 week). The original index consists of 24 Questions. Individual question response is assigned a score of between 0 (none) to 4 (extreme) and summed to form a score ranging from 0 (best) to 96 (worst).
4 secondary outcomes
Changes in Lysholm Index Score
Time frame: 12 weeks
Changes in Hs-CRP(High Sensitivity C-reactive Protein)
Time frame: 12 weeks
Changes in OSC(Osteocalcin)
Time frame: 12 weeks
Changes in DPD(Deoxypyridinoline)
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Jeong-Hwan Seo, MD principal investigator
Chonbuk National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Omija extract. in people with Mild Knee Osteoarthritis, run by Chonbuk National University Hospital at 1 site 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 5 inclusion and 7 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 4 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Feb 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Changes in WOMAC (Western Ontario and McMaster University Osteoarthritis Index) Totol Score (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Feb 2013.