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: 1. To evaluate the effectiveness of the joint functional state-supporting properties of dietary supplement ARTNEO®, capsules for oral administration, in patients with stage II-III primary osteoarthritis of the knee joint; 2. To evaluate the safety of dietary supplement ARTNEO®, capsules for oral administration, in patients with stage II-III primary osteoarthritis of the knee joint. Participants will be randomly distributed equally among two groups: * Group 1 "ARTNEO" (106 people): patients take the study dietary supplement ARTNEO®, 1 capsule 1 time per day for 6 months; * Group 2 "Placebo" (106 people): patients take placebo 1 capsule 1 time per day for 6 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
212
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.
Release form: capsules with an average weight of 585 mg. No active ingredients.
NIMK Vashe Zdorovie LLC
Kazan', Russia
Federal State Budgetary Scientific Institution "Research Institute of Rheumatology named after V.A. Nasonova"
Moscow, Russia
Pirogov Russian National Research Medical University
Moscow, Russia
Research Center Eco-Safety LLC
Saint Petersburg, Russia
Energiia Zdoroviya LLC
Saint Petersburg, Russia
"Medical Sanitary Unit No. 157" LLC
Saint Petersburg, Russia
Research Center Eco-Safety LLC
Saint Petersburg, Russia
Zvezdnaya Clinic LLC
Saint Petersburg, Russia
Meili LLC
Saint Petersburg, Russia
State Health Institution "Tula Regional Clinical Dermatovenerologic Dispensary"
Tula, Russia
...and 2 more locations
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).
Time frame: Baseline to month 6
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);
Time frame: Baseline to months 1, 2, 3, 4, 6
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)
Time frame: 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);
Time frame: 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;
Time frame: 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;
Time frame: 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)
Time frame: 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)
Time frame: Baseline to month 1, 2, 3, 4, 6
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