Knee OsteoarthritisPhase 3NCT00503828
Derris Scandens Benth Extract VS Naproxen in Knee OA
A Phase 3 study testing Derris scandens Benth extracts and naproxen in people with Knee Osteoarthritis, run by Mahidol University at 1 site in Thailand.
Trial summary
Derris Scandens Benth (family : Leguminosae) is a woody vine growing throughout Southeast Asia, including Thailand. The stem of D.Scandens has been widely use in Thai traditional medicine, foe example of myalgia. Previous study shown that D.Scandens Benth extract has the anti-inflammatory activity. Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Derris scandens Benth extracts and naproxen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteThailand
- Study dates
- Jul 2007to Mar 2009
- Phase
- Phase 3
- 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 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age >=50 yr
- Known case of primary knee osteoarthritis
- WOMAC pain subscale (item1) >= 5
- signed informed consent
Who cannot join
- hypersensitive to NSAIDs
- history of peptic ulcer or melena
- unable to walk , i.e. patient with severe spinal stenosis, myocardial infarction
- history of intra-articular injection of knee within 3 months
- status post knee replacement
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy and Safety of Derris Scandens Benth Extract and Naproxen for Therapy of Patients With Knee Osteoarthritis
Derris Scandens Benth (family : Leguminosae) is a woody vine growing throughout Southeast Asia, including Thailand. The stem of D.Scandens has been widely use in Thai traditional medicine, foe example of myalgia. Previous study shown that D.Scandens Benth extract has the anti-inflammatory activity. Although NSAIDs are efficaciously in the treatment of osteoarthritis,but the GI side effect is still concerned. In this study we aim to investigate the efficacy and safety of D. Scandens Benth extract compared with Naproxen for therapy of patients with knee osteoarthritis.
- Conditions
- Knee Osteoarthritis
- Being tested
- Derris scandens Benth extracts, naproxen
- Keywords
- Derris Scandens Benth extract, Osteoarthritis, WOMAC, 6-minute walk
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Derris scandens Benth extractsDrug
Derris scandens Benth extracts (oral) 400 mg twice per day for 4 weeks
naproxenDrug
Naproxen 500 mg/day for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| naproxen | Active comparator | Naproxen 500 mg/day for 4 weeks Receives: Drug: naproxen |
| Derris Scandens Benth | Experimental | Derris Scandens Benth Receives: Drug: Derris scandens Benth extracts |
What is being measured
The primary outcome is the main question the study is designed to answer.
WOMAC score
Measured: 2, 4 weeks
Secondary outcomes (1)
6-minute walk, Quality of Life, adverse event
Measured: 2, 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2007 (estimated)
- Study startJul 2007
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Thailand
- Investigators
- Vilai Kuptniratsaikul, Assoc.Prof., Principal investigator, Department of Rehabilitation Medicine, Faculty of Medicine Siriraj Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00503828
- Sponsor's protocol ID
- Siriraj CEU 50-001
- Status last verified
- Jun 2009
- First submitted
- 18 Jul 2007
- Last updated
- 13 Jan 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Derris Scandens Benth Extract and Naproxen for Therapy of Patients With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT00503828
- Acronym / sponsor ID
- Siriraj CEU 50-001
- Conditions
- Knee Osteoarthritis
- Keywords
- Derris Scandens Benth extract, Osteoarthritis, WOMAC, 6-minute walk
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Collaborators
- Ministry of Health, Thailand
- Study start
- Jul 2007
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 19 Jul 2007 (estimated)
- 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.
Derris Scandens Benth (family : Leguminosae) is a woody vine growing throughout Southeast Asia, including Thailand. The stem of D.Scandens has been widely use in Thai traditional medicine, foe example of myalgia. Previous study shown that D.Scandens Benth extract has the anti-inflammatory activity. Although NSAIDs are efficaciously in the treatment of osteoarthritis,but the GI side effect is still concerned. In this study we aim to investigate the efficacy and safety of D. Scandens Benth extract compared with Naproxen for therapy of patients with knee osteoarthritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| naproxen | Active comparator | Drug: naproxenNaproxen 500 mg/day for 4 weeks |
| Derris Scandens Benth | Experimental | Drug: Derris scandens Benth extractsDerris Scandens Benth |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age >=50 yr
- Known case of primary knee osteoarthritis
- WOMAC pain subscale (item1) >= 5
- signed informed consent
Key exclusion criteria (5 listed)
- hypersensitive to NSAIDs
- history of peptic ulcer or melena
- unable to walk , i.e. patient with severe spinal stenosis, myocardial infarction
- history of intra-articular injection of knee within 3 months
- status post knee replacement
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 |
|---|---|---|
| Derris scandens Benth extractsDerris scandens Benth extracts (oral) 400 mg twice per day for 4 weeks | Drug | Derris Scandens Benth |
| naproxenNaproxen 500 mg/day for 4 weeks | Drug | naproxen |
Primary outcome
WOMAC score
Time frame: 2, 4 weeks
1 secondary outcome
6-minute walk, Quality of Life, adverse event
Time frame: 2, 4 weeks
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 13 Jan 2010.
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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.
Vilai Kuptniratsaikul, Assoc.Prof. principal investigator
Department of Rehabilitation Medicine, Faculty of Medicine Siriraj Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Derris scandens Benth extracts and naproxen in people with Knee Osteoarthritis, run by Mahidol University at 1 site in Thailand.
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 5 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 13 Jan 2010. 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 Thailand. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
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?
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?
WOMAC score (time frame: 2, 4 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 13 Jan 2010.