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The goal of this clinical study is to evaluate the effectiveness of the properties that support the functional state of the joints and the safety of the dietary supplement for food ARTNEO®, oral capsules, in patients with stage II-III primary osteoarthritis of the knee joint.
The main questions it aims to answer are:
Participants will be randomly distributed equally among two groups:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ARTNEO | Active Comparator | 1 capsule 1 time per day for 6 months |
|
| Placebo | Placebo Comparator | 1 capsule 1 time per day for 6 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| undenaturated collagen type II, methylsulfonylmethane, boswellia serrata, vitamin D3 (cholecalciferol), vitamin C (ARTNEO) | Dietary Supplement | Release form: capsules with an average weight of 585 mg. Active ingredients: MCM (methylsulfonylmethane) 300 mg, vitamin C (ascorbic acid) 80 mg, boswellia extract (65% boswellic acids) 50.05 mg, undenatured (native) type II collagen 40 mg, vitamin D3 (cholecalciferol) 400 IU. Suggested Use: Adults, 1 capsule daily with meals. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in WOMAC-T score | Change in total Western Ontario and McMaster University Osteoarthritis Index score (WOMAC-T) at Visit 7 (Day 180 ± 4) from start of study dietary supplement/placebo compared to baseline (at Visit 2, Day 1). | Baseline to month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the mean score on the subscales of WOMAC | Change in the mean score on the subscales of Western Ontario and McMaster University Osteoarthritis Index (WOMAC) (pain, stiffness, functional impairment) at Visit 3 (day 30 ± 2), Visit 4 (day 60 ± 2), Visit 5 (day 90 ± 3), Visit 6 (day 120 ± 3) ) and Visit 7 (Day 180 ± 4) compared to baseline (at Visit 2, Day 1); | Baseline to months 1, 2, 3, 4, 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Synovitis severity | Assessing the severity of synovitis according to the results of ultrasound examination of the target knee joint from the basal level (Visit 2, Day 1) at Visit 7 (Day 180 ± 4) | Baseline to month 6 |
| 14-day pain VAS assessment |
Inclusion Criteria:
Exclusion Criteria:
Individual intolerance to the active or excipients of the ARTNEO® dietary supplement (undenatured type II collagen + methylsulfonylmethane + Boswellia serrata extract + vitamin C + Vitamin D3), placebo and the "rescue" drug ibuprofen;
Intolerance to eggs, poultry, shellfish;
History of trauma or surgery on the target knee joint (other than diagnostic arthroscopy more than 60 days old at study entry), expected surgery (within 6 months following inclusion);
Coronary artery bypass grafting in medical history;
Diseases, the presence of which, from the point of view of the research physician, puts the patient's health at risk in case of participation in the study or potentially complicates the interpretation of the results of the study (may affect the assessment of endpoints):
Mental and / or neurological diseases with partial or complete loss of legal capacity;
Presence or suspicion of drug, alcohol or drug addiction;
Intra-articular injection into the target knee joint:
The need for constant use of glucocorticoids in any dosage form;
Use, including single use, of paracetamol, NSAIDs in any dosage form, and other pain medications within the last 48 hours prior to the randomization visit. Use within 7 days before randomization of certain natural products (such as soy, avocado, passion fruit, pineapple, turmeric, linseed, rapeseed, soybean oils, chia seeds, walnuts, decoction of willow bark, pine, mugwort), L-carnitine;
The use of glucosamine or chondroitin during the last 3 months before randomization with a course duration of more than 3 months (if the duration of the course of glucosamine or chondroitin was less than 3 months, then this therapy must be abandoned throughout the study from the moment of the screening visit);
Use of ω-3 polyunsaturated fatty acid preparations within 14 days prior to randomization, therapeutic doses of fish oils (≥ 2 g/day) and shark cartilage preparations within 6 months prior to randomization (except vitamin D3);
Participation in any clinical trial currently or in the previous 30 days or 5 half-lives (whichever is longer) prior to the Screening visit;
History of oral undenatured type II collagen therapy in the last 4 months prior to the screening visit;
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| Name | Affiliation | Role |
|---|---|---|
| Ludmila Alekseeva, MD | FSBSI "Research Institute of Rheumatology named after V.A. Nasonova" | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NIMK Vashe Zdorovie LLC | Kazan' | 420097 | Russia | |||
| Federal State Budgetary Scientific Institution "Research Institute of Rheumatology named after V.A. Nasonova" |
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|
| Placebo | Dietary Supplement | Release form: capsules with an average weight of 585 mg. No active ingredients. |
|
| Change in WOMAC-T score (expt month 6) | Change in total Western Ontario and McMaster University Osteoarthritis Index score (WOMAC-T) at Visit 3 (day 30 ± 2), Visit 4 (day 60 ± 2), Visit 5 (day 90 ± 3), Visit 6 (day 120 ± 3) compared to basal value (on Visit 2, day 1) | Baseline to months 1, 2, 3, 4 |
| Change in KOOS | Changes in target joint functional state assessment according to Knee injury and Osteoarthritis Outcome Score (KOOS) at Visit 3 (day 30 ± 2), Visit 4 (day 60 ± 2), Visit 5 (day 90 ± 3), Visit 6 (day 120 ± 3) and Visit 7 (day 180 ± 4) compared to baseline (at Visit 2, day 1); | Baseline to months 1, 2, 3, 4, 6 |
| Ibuprofen intake | Cumulative oral dose of ibuprofen since day 1 (Visit 2, day 1) and number of patients (%) reporting ibuprofen use; | Baseline to month 6 |
| Drop-out number | The number of patients dropping out (%) due to the need to prescribe non-steroidal anti-inflammatory drugs (NSAIDs) and other pain medications (with the exception of the drug "rescue" ibuprofen in the doses established by the protocol) or the need to increase the dose allowed under the protocol (more than 1200 mg / day) of ibuprofen; | Baseline to month 6 |
| EQ-5D assessment | European Quality of Life Questionnaire (EQ-5D) Health Assessment from Baseline (Visit 2, Day 1) at Visit 3 (Day 30 ± 2), Visit 4 (Day 60 ± 2), Visit 5 (Day 90 ± 3), Visit 6 (day 120 ± 3) and Visit 7 (day 180 ± 4) | Baseline to month 6 |
| Pain VAS assessment | Pain assessment in the target knee on 100 mm visual analog scale (VAS) relative to baseline (Visit 2, Day 1) at Visit 3 (Day 30 ± 2), Visit 4 (Day 60 ± 2), Visit 5 (day 90 ± 3), Visit 6 (day 120 ± 3) and Visit 7 (day 180 ± 4) | Baseline to month 1, 2, 3, 4, 6 |
Assessment of the severity of pain when walking in the target knee joint on a 100-mm visual analog scale (VAS) relative to the basal level (Visit 2, day 1) on day 14±1.
| Baseline to day 14 |
| Moscow |
| 115522 |
| Russia |
| Pirogov Russian National Research Medical University | Moscow | 117997 | Russia |
| Research Center Eco-Safety LLC | Saint Petersburg | 191119 | Russia |
| Energiia Zdoroviya LLC | Saint Petersburg | 194156 | Russia |
| "Medical Sanitary Unit No. 157" LLC | Saint Petersburg | 196066 | Russia |
| Research Center Eco-Safety LLC | Saint Petersburg | 196143 | Russia |
| Zvezdnaya Clinic LLC | Saint Petersburg | 196158 | Russia |
| Meili LLC | Saint Petersburg | 199397 | Russia |
| State Health Institution "Tula Regional Clinical Dermatovenerologic Dispensary" | Tula | 300053 | Russia |
| Ulyanovsk Regional Clinical Hospital | Ulyanovsk | 432017 | Russia |
| Private educational institution of additional professional education 'Institute for advanced training and professional retraining of personnel | Yaroslavl | Russia |
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| C025910 | dimethyl sulfone |
| D065260 | Frankincense |
| D002762 | Cholecalciferol |
| D001205 | Ascorbic Acid |
| ID | Term |
|---|---|
| D012116 | Resins, Plant |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D053147 | Plant Exudates |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
| D013400 | Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D006880 | Hydroxy Acids |
| D002241 | Carbohydrates |
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