Osteo Arthritis KneePhase 4NCT05925725
Clinical Efficacy and Safety of Loxacon Dietary Supplement Capsules at Patients With Knee Arthrosis
A Phase 4 study testing • harpagozid • boswellin = LOXACON in people with Osteo Arthritis Knee, run by Polyclinic of the Hospitaller Brothers of St. John of God, Budapest at 1 site in Hungary.
Trial summary
The study will be a multicenter, randomized, double-blind, follow-up clinical trial. Neither the examining doctor nor the patient knows which capsule they will receive. Just the test unlock the codes after completion. T Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Osteo Arthritis Knee
- What is being tested?
- • harpagozid • boswellin = LOXACON
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteHungary
- Study dates
- 25 Jan 2023to 6 Sep 2023
- Phase
- Phase 4
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- According to the ACR (American College of Rheumatology) knee arthrosis criteria, knee arthrosis supported by an imaging procedure (comparative knee X-ray). Both in the case of knee involvement, the more complaining knee will be examined! 2. A patient reporting knee pain characteristic of knee arthrosis for at least 3 months, where the VAS value 40-70 mm. 3. With a diagnosis of mild and moderate knee arthrosis. 4. Male or female patients between the ages of 40 and 80. 5. With a BodyMassIndex between 25-35.
Who cannot join
- Intra-articular corticosteroid within 3 months before starting treatment injection.
- Intra-articular hyaluronic acid treatment within 6 months or such treatment during the examination treatment.
- Physiotherapy treatment received within 3 months prior to the start of the treatment.
- NSAID changed within 3 months prior to treatment or during treatment, or chondroprotective treatment.
- In inflammatory rheumatological diseases (RA, SPA, APs, crystal arthropathies, etc.) suffering patient.
- Knee surgery within 6 months prior to the examination.
Show all 12Show fewer
- Presence of a metal implant in the knee joint.
- Patients who had a knee joint injury within 6 months prior to the examination.
- Patients with a palpable fluid collection in the knee or Baker's cyst.
- Uncooperative patients, patients with inadequate mental or psychological status.
- Clinical diagnosis of Alzheimer's Disease
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Efficacy and Safety of Loxacon Dietary Supplement Capsules at the Treatment of Patients With Knee Arthrosis. A Multicenter Randomized, Double-blind, Follow-up Clinical Trial
The study will be a multicenter, randomized, double-blind, follow-up clinical trial.
Neither the examining doctor nor the patient knows which capsule they will receive. Just the test unlock the codes after completion. T
Read the detailed description
The study will be a multicenter, randomized, double-blind, follow-up clinical trial.
Neither the examining doctor nor the patient knows which capsule they will receive. Just the test unlock the codes after completion. The randomization was performed externally, not included in the study performed by a person. Number of patients: a total of 105 patients / 25-25 per clinic (with 8 patients each in three treatment groups) Three treatment groups
- 35 people physical therapy + Loxacon
- 35 main physical therapy + Placebo
- 35 people only for physical therapy Physiotherapy(exercise) takes place according to a uniform protocol. Physiotherapy 2x30 minutes per week for 5 weeks (10 times in total). The course of the investigation
- st visit: selection, filling in questionnaires
- nd visit: after the 10th exercise session, while taking Loxacon/placebo, filling in questionnaires
- rd visit: Uniformly after another 2 months of taking Loxacon, in all three groups, completing questionnaires After the first 5 weeks, all three branches will receive enough Loxacon capsules for 2 months! The parameters to be tested
- WOMAC test
- VAS
- EQ-5D-5L quality of life test
- Goniometer angle measurement The test is completed by patients who participated in more than 70% of the treatment! Monitoring of side effects It is the duty of the doctor of the given center - who reports to the investigator.
- Conditions
- Osteo Arthritis Knee
- Being tested
- • harpagozid • boswellin = LOXACON
- Keywords
- Boswellia serrata,, Harpagophytum procumbens,, knee OA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
• harpagozid • boswellin = LOXACONDrug
Also called Physiotherapy(exercise)
Exercise therapy
| Study group | Role | What they receive |
|---|---|---|
| Loxacon and Physical Therapy | Active comparator | physical therapy(exercise) + caps Loxacon Receives: Drug: • harpagozid • boswellin = LOXACON |
| Physical therapy and Placebo Loxacon caps | Placebo comparator | Physical therapy + Placebo caps Loxacon Receives: Drug: • harpagozid • boswellin = LOXACON |
| Pphysical therapy(alone) | Active comparator | Physical therapy Receives: Drug: • harpagozid • boswellin = LOXACON |
What is being measured
The primary outcome is the main question the study is designed to answer.
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
The test questions are scored on a scale of 0-4, whichcorrespondto: None (0), Mild (1)
, Moderate (2), Severe (3), and Extreme (4).
Measured: one year
Visual analog The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be')
pain measurement The higher score the worser
Measured: "through study completion, an average of 1 year".
GONIOMETER
Range of motion(0-140)Goniometry is the art and science of measuring the joint ranges in each plane of the joint.The hihger the movements's degree the better the result of exercise
Measured: "through study completion, an average of 1 year".
Knee Injury and Osteoarthritis Outcome Score (KOOS)
The KOOS evaluates both short-term and long-term consequences of knee injury. It holds 42 items in 5 separately scored subscales; Pain, otherSymptoms, Function in dailyliving (ADL), Function in Sport and Recreation (Sport/Rec), and knee-relatedQuality of Life (QOL)KOOS consists of 5 subscales; long-term patient-relevant outcomes following knee injury
Measured: "through study completion, an average of 1 year".
Secondary outcomes (1)
Euroquol Group index EQ-5D-he EQ-5D
is a commonly used general questionnaire belonging to the first group. When filling it out, respondents in 5 dimensions: mobility, self-sufficiency, usual activities, pain/discomfort, anxiety/depression; They can choose from 3 levels (1: least, 3: most).
Measured: "through study completion, an average of 1 year".
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2023
- Study start25 Jan 2023
- Primary completion5 May 2023
- Study completion6 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteo Arthritis KneeStudies 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 4
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Polyclinic of the Hospitaller Brothers of St. John of God, Budapest
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tamas Bender, Polyclinic of the Hospitaller Brothers of St. John of God, Budapest
- Investigators
- Zoltán Dégi, M.D, Study director, Goodwill PharmaZoltán Dégi, Study chair, Goodwill PharmaTamas Bender, Principal investigator, Polyclinic of the Hospitaller Brothers of St. John of God, Budapest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05925725
- Sponsor's protocol ID
- PolyclinicHBSJG physiothetrapy
- Status last verified
- Nov 2023
- First submitted
- 7 Apr 2023
- Last updated
- 15 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy and Safety of Loxacon Dietary Supplement Capsules at the Treatment of Patients With Knee Arthrosis. A Multicenter Randomized, Double-blind, Follow-up Clinical Trial
- ClinicalTrials.gov ID
- NCT05925725
- Acronym / sponsor ID
- PolyclinicHBSJG physiothetrapy
- Conditions
- Osteo Arthritis Knee
- Keywords
- Boswellia serrata,, Harpagophytum procumbens,, knee OA
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Polyclinic of the Hospitaller Brothers of St. John of God, BudapestUniversity, hospital or other
- Study start
- 25 Jan 2023 (actual)
- Primary completion
- 5 May 2023 (actual)
- Study completion
- 6 Sep 2023 (actual)
- First posted
- 29 Jun 2023 (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 study will be a multicenter, randomized, double-blind, follow-up clinical trial.
Neither the examining doctor nor the patient knows which capsule they will receive. Just the test unlock the codes after completion. T
Detailed description
The study will be a multicenter, randomized, double-blind, follow-up clinical trial.
Neither the examining doctor nor the patient knows which capsule they will receive. Just the test unlock the codes after completion. The randomization was performed externally, not included in the study performed by a person. Number of patients: a total of 105 patients / 25-25 per clinic (with 8 patients each in three treatment groups) Three treatment groups
- 35 people physical therapy + Loxacon
- 35 main physical therapy + Placebo
- 35 people only for physical therapy Physiotherapy(exercise) takes place according to a uniform protocol. Physiotherapy 2x30 minutes per week for 5 weeks (10 times in total). The course of the investigation
- st visit: selection, filling in questionnaires
- nd visit: after the 10th exercise session, while taking Loxacon/placebo, filling in questionnaires
- rd visit: Uniformly after another 2 months of taking Loxacon, in all three groups, completing questionnaires After the first 5 weeks, all three branches will receive enough Loxacon capsules for 2 months! The parameters to be tested
- WOMAC test
- VAS
- EQ-5D-5L quality of life test
- Goniometer angle measurement The test is completed by patients who participated in more than 70% of the treatment! Monitoring of side effects It is the duty of the doctor of the given center - who reports to the investigator.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Loxacon and Physical Therapy | Active comparator | Drug: • harpagozid • boswellin = LOXACONphysical therapy(exercise) + caps Loxacon |
| Physical therapy and Placebo Loxacon caps | Placebo comparator | Drug: • harpagozid • boswellin = LOXACONPhysical therapy + Placebo caps Loxacon |
| Pphysical therapy(alone) | Active comparator | Drug: • harpagozid • boswellin = LOXACONPhysical therapy |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- According to the ACR (American College of Rheumatology) knee arthrosis criteria, knee arthrosis supported by an imaging procedure (comparative knee X-ray). Both in the case of knee involvement, the more complaining knee will be examined! 2. A patient reporting knee pain characteristic of knee arthrosis for at least 3 months, where the VAS value 40-70 mm. 3. With a diagnosis of mild and moderate knee arthrosis. 4. Male or female patients between the ages of 40 and 80. 5. With a BodyMassIndex between 25-35.
Key exclusion criteria (12 listed)
- Intra-articular corticosteroid within 3 months before starting treatment injection.
- Intra-articular hyaluronic acid treatment within 6 months or such treatment during the examination treatment.
- Physiotherapy treatment received within 3 months prior to the start of the treatment.
- NSAID changed within 3 months prior to treatment or during treatment, or chondroprotective treatment.
- In inflammatory rheumatological diseases (RA, SPA, APs, crystal arthropathies, etc.) suffering patient.
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 |
|---|---|---|
| • harpagozid • boswellin = LOXACONAlso: Physiotherapy(exercise)Exercise therapy | Drug | Loxacon and Physical Therapy, Physical therapy and Placebo Loxacon caps, Pphysical therapy(alone) |
Primary outcome
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Time frame: one year
The test questions are scored on a scale of 0-4, whichcorrespondto: None (0), Mild (1) , Moderate (2), Severe (3), and Extreme (4).
Visual analog The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be')
Time frame: "through study completion, an average of 1 year".
pain measurement The higher score the worser
GONIOMETER
Time frame: "through study completion, an average of 1 year".
Range of motion(0-140)Goniometry is the art and science of measuring the joint ranges in each plane of the joint.The hihger the movements's degree the better the result of exercise
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: "through study completion, an average of 1 year".
The KOOS evaluates both short-term and long-term consequences of knee injury. It holds 42 items in 5 separately scored subscales; Pain, otherSymptoms, Function in dailyliving (ADL), Function in Sport and Recreation (Sport/Rec), and knee-relatedQuality of Life (QOL)KOOS consists of 5 subscales; long-term patient-relevant outcomes following knee injury
1 secondary outcome
Euroquol Group index EQ-5D-he EQ-5D
Time frame: "through study completion, an average of 1 year".
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 15 Nov 2023.
- Individual participant dataSharing planned: No
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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.
Zoltán Dégi, M.D study director
Goodwill Pharma
Zoltán Dégi study chair
Goodwill Pharma
Tamas Bender principal investigator
Polyclinic of the Hospitaller Brothers of St. John of God, Budapest
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing • harpagozid • boswellin = LOXACON in people with Osteo Arthritis Knee, run by Polyclinic of the Hospitaller Brothers of St. John of God, Budapest at 1 site in Hungary.
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 1 inclusion and 12 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 15 Nov 2023. 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 Hungary. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Western Ontario and McMaster Universities Arthritis Index (WOMAC) (time frame: one year). The study lists 4 primary outcomes in all. 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 15 Nov 2023.