OsteoarthritisPhase 1NCT01010919
A Study of Chicory for Treatment of Osteoarthritis of the Hip or Knee
A Phase 1 study testing Chicory root extract in people with Osteoarthritis, run by Phytomedics Inc..
Trial summary
Extracts of chicory root have anti-inflammatory properties in vitro and in animal models of arthritis. The primary objective of this investigator-initiated, Phase 1, placebo-controlled, double blind, dose-escalating trial is to determine the safety and tolerability of a proprietary bioactive extract of chicory root in… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Chicory root extract
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Phase 1
- 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 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- Patients must be 50 years of age or older and may be of either gender.
- Patients must have have an imaging-confirmed (radiograph or MRI) diagnosis of OA of the hip or knee.
- Patients must not have taken a nonsteroidal anti-inflammatory medication for at least 7 days prior to the baseline visit (a single daily aspirin 325 mg or less is allowed throughout the study).
- Patients must be able and willing to give informed consent.
Who cannot join
- Any unstable comorbid medical condition that in the opinion of the investigator could interfere with the ability of the patient to complete the study.
- Patients who are unable to ambulate and require a wheelchair due to the severity of the arthritis are excluded. Ambulatory aids such as canes and walkers are acceptable.
- Patients requiring continuing therapy with nonsteroidal anti-inflammatory drugs are excluded.
- Patients requiring any dose of glucocorticoids within the past 30 days are excluded.
About this study
Official title: A Phase I Study of Chicory for Treatment of Osteoarthritis of the Hip or Knee
Extracts of chicory root have anti-inflammatory properties in vitro and in animal models of arthritis. The primary objective of this investigator-initiated, Phase 1, placebo-controlled, double blind, dose-escalating trial is to determine the safety and tolerability of a proprietary bioactive extract of chicory root in patients with osteoarthritis (OA). Secondary objectives are to assess effects on the signs and symptoms of this disorder. Individuals greater than 50 years of age with OA of the hip or knee will be eligible for trial entry.
- Conditions
- Osteoarthritis
- Being tested
- Chicory root extract
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chicory root extractDietary supplement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2009 (estimated)
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 1
Sponsor and investigators
- Lead sponsor
- Phytomedics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Texas, Southwestern Medical Center at Dallas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01010919
- Sponsor's protocol ID
- PMI-005-01
- Status last verified
- Nov 2009
- First submitted
- 6 Nov 2009
- Last updated
- 10 Nov 2009
- Results posted
- No
Publications
Olsen NJ, Branch VK, Jonnala G, Seskar M, Cooper M. Phase 1, placebo-controlled, dose escalation trial of chicory root extract in patients with osteoarthritis of the hip or knee. BMC Musculoskelet Disord. 2010 Jul 9;11:156. doi: 10.1186/1471-2474-11-156.
PubMed 20618964
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Chicory for Treatment of Osteoarthritis of the Hip or Knee
- ClinicalTrials.gov ID
- NCT01010919
- Acronym / sponsor ID
- PMI-005-01
- Conditions
- Osteoarthritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Phytomedics Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of Texas, Southwestern Medical Center at Dallas
- First posted
- 10 Nov 2009 (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.
Extracts of chicory root have anti-inflammatory properties in vitro and in animal models of arthritis. The primary objective of this investigator-initiated, Phase 1, placebo-controlled, double blind, dose-escalating trial is to determine the safety and tolerability of a proprietary bioactive extract of chicory root in patients with osteoarthritis (OA). Secondary objectives are to assess effects on the signs and symptoms of this disorder. Individuals greater than 50 years of age with OA of the hip or knee will be eligible for trial entry.
Study design
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients must be 50 years of age or older and may be of either gender.
- Patients must have have an imaging-confirmed (radiograph or MRI) diagnosis of OA of the hip or knee.
- Patients must not have taken a nonsteroidal anti-inflammatory medication for at least 7 days prior to the baseline visit (a single daily aspirin 325 mg or less is allowed throughout the study).
- Patients must be able and willing to give informed consent.
Key exclusion criteria (4 listed)
- Any unstable comorbid medical condition that in the opinion of the investigator could interfere with the ability of the patient to complete the study.
- Patients who are unable to ambulate and require a wheelchair due to the severity of the arthritis are excluded. Ambulatory aids such as canes and walkers are acceptable.
- Patients requiring continuing therapy with nonsteroidal anti-inflammatory drugs are excluded.
- Patients requiring any dose of glucocorticoids within the past 30 days are excluded.
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 |
|---|---|---|
| Chicory root extract | Dietary supplement | – |
Primary outcome
Not reported in the source record.
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 10 Nov 2009.
- Derived from this study: PubMed 20618964Olsen NJ, Branch VK, Jonnala G, Seskar M, Cooper M. Phase 1, placebo-controlled, dose escalation trial of chicory root extract in patients with osteoarthritis of the hip or knee. BMC Musculoskelet Disord. 2010 Jul 9;11:156. doi: 10.1186/1471-2474-11-156.
Related trials for Osteoarthritis
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Osteoarthritis (OA) of the Hip
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Chicory root extract in people with Osteoarthritis, run by Phytomedics Inc..
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 4 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 10 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01010919, 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 10 Nov 2009.