OsteoarthritisNCT00666523
Effect of Phytalgic in Osteoarthritis (OA)
A study testing phytalgic in people with Osteoarthritis, run by Université Victor Segalen Bordeaux 2 at 1 site in France.
Trial summary
The objective of the study is to test the effects of a herbal supplement, Phytalgic, on the symptoms of osteoarthritis of the knee or hip, in patients with OA using NSAIDs or analgesics on a regular basis. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- phytalgic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 81 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2007to Apr 2008
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- knee or hip osteoarthritis
- regular NSAIDs/analgesic treatment
- signed inform consent
Who cannot join
- incapacity to understand study
- irregular NSAID treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Double-Blind Study of Food Supplement Phytalgic on Symptoms of Osteoarthritis
The objective of the study is to test the effects of a herbal supplement, Phytalgic, on the symptoms of osteoarthritis of the knee or hip, in patients with OA using NSAIDs or analgesics on a regular basis.
- Conditions
- Osteoarthritis
- Being tested
- phytalgic, placebo
- Keywords
- osteoarthritis, knee or hip
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
phytalgicDietary supplement
3/day
placeboDietary supplement
3/Day
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Dietary Supplement: phytalgic |
| 2 | 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.
use of NSAIDs or analgesics
Measured: 3 months
Secondary outcomes (1)
WOMAC function scale
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2008 (estimated)
- Study startJan 2007
- Primary completionJan 2008
- Study completionApr 2008
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université Victor Segalen Bordeaux 2
- Sponsor type
- University, hospital or other
- Collaborators
- laboratoire Phythea, France
- Investigators
- Nicholas Moore, MD, PhD, Study director, University of Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00666523
- Sponsor's protocol ID
- PhytalgicOA
- Status last verified
- Apr 2008
- First submitted
- 23 Apr 2008
- Last updated
- 25 Apr 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Jacquet A, Girodet PO, Pariente A, Forest K, Mallet L, Moore N. Phytalgic, a food supplement, vs placebo in patients with osteoarthritis of the knee or hip: a randomised double-blind placebo-controlled clinical trial. Arthritis Res Ther. 2009;11(6):R192. doi: 10.1186/ar2891. Epub 2009 Dec 16.
PubMed 20015358
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Double-Blind Study of Food Supplement Phytalgic on Symptoms of Osteoarthritis
- ClinicalTrials.gov ID
- NCT00666523
- Acronym / sponsor ID
- PhytalgicOA
- Conditions
- Osteoarthritis
- Keywords
- osteoarthritis, knee or hip
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Université Victor Segalen Bordeaux 2University, hospital or other
- Collaborators
- laboratoire Phythea, France
- Study start
- Jan 2007
- Primary completion
- Jan 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 25 Apr 2008 (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.
The objective of the study is to test the effects of a herbal supplement, Phytalgic, on the symptoms of osteoarthritis of the knee or hip, in patients with OA using NSAIDs or analgesics on a regular basis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Dietary Supplement: phytalgic |
| 2 | Placebo comparator | Dietary Supplement: placebo |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- knee or hip osteoarthritis
- regular NSAIDs/analgesic treatment
- signed inform consent
Key exclusion criteria (2 listed)
- incapacity to understand study
- irregular NSAID treatment
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 |
|---|---|---|
| phytalgic3/day | Dietary supplement | 1 |
| placebo3/Day | Dietary supplement | 2 |
Primary outcome
use of NSAIDs or analgesics
Time frame: 3 months
1 secondary outcome
WOMAC function scale
Time frame: 3 months
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 Apr 2008.
- Derived from this study: PubMed 20015358Jacquet A, Girodet PO, Pariente A, Forest K, Mallet L, Moore N. Phytalgic, a food supplement, vs placebo in patients with osteoarthritis of the knee or hip: a randomised double-blind placebo-controlled clinical trial. Arthritis Res Ther. 2009;11(6):R192. doi: 10.1186/ar2891. Epub 2009 Dec 16.
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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.
Nicholas Moore, MD, PhD study director
University of Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing phytalgic in people with Osteoarthritis, run by Université Victor Segalen Bordeaux 2 at 1 site in France.
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 3 inclusion and 2 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 Apr 2008. 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 France. 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?
use of NSAIDs or analgesics (time frame: 3 months). 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 NCT00666523, 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 Apr 2008.