The goal of the interventional study is to assess the effectiveness of the supporting properties and safety of the dietary supplement ARTNEO (ARTNEO®), capsules with an average weight of 585 mg, in patients with osteoarthritis of the knee joint of both sexes aged 40 to 75 years. The main questions it aims to answer are: 1. To evaluate the effectiveness of the supporting properties of dietary supplement ARTNEO (ARTNEO®) in patients with knee osteoarthritis in comparison with active control; 2. To evaluate the safety of the dietary supplement ARTNEO (ARTNEO®) in patients with knee osteoarthritis
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
70
Dietary Supplement: undenatured collagen type II, methylsulfonylmethane, boswellia serrata, vitamin D3 (cholecalciferol), vitamin C (ARTNEO) 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.
Active ingredients: Glucosamine hydrochloride 500 mg Chondroitin sulfate sodium 500 mg Excipients: dibasic calcium phosphate, microcrystalline cellulose, croscarmellose sodium, stearic acid, magnesium stearate. Orally; adults and children over 15 years of age are prescribed 1 tablet 2 times a day for the first three weeks; 1 tablet 1 time per day for the next weeks and months.
Federal State Budgetary Educational Institution of Higher Education "North-Western State Medical University named after I.I. Mechnikov" of the Ministry of Health of Russia
Saint Petersburg, Sankt-Peterburg, Russia
Change in the mean of the total score on The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scale
Change in total WOMAC score at Visit 9 (day 180 ± 4) from baseline at Visit 2 (day 1)
Time frame: Baseline to month 6
Change in mean WOMAC total score (baseline to day 7, months 1 and 3)
Change in mean WOMAC total score at Visit 3 (Day 7 ± 2), Visit 4 (Day 30 ± 2), Visit 6 (Day 90 ± 3) from baseline at Visit 2 (Day 1)
Time frame: Baseline to day 7, months 1 and 3
Change in the mean on the subscales of the WOMAC (scales of pain, stiffness, functional insufficiency)
Change in the mean score on subscales of the WOMAC scale (pain, stiffness, functional impairment scale) at Visit 3 (Day 7 ± 2), Visit 4 (Day 30 ± 2), Visit 6 (Day 90 ± 3) and Visit 9 (Day 180) ± 4) compared to baseline at Visit 2 (Day 1)
Time frame: Baseline to day 7, months 1, 3, 6
Change in the mean score on the Lequesne scale
Change in the mean score on the Lequesne scale (gonarthrosis severity index) at Visit 3 (day 7 ± 2), at Visit 4 (day 30 ± 2), Visit 6 (day 90 ± 3) and Visit 9 (day 180 ± 4) by compared to baseline (at Visit 2, Day 1)
Time frame: Baseline to day 7, months 1, 3, 6
Evaluation of magnetic resonance imaging (MRI) signs of damage to the target joint
Evaluation of MRI signs of damage to the target joint according to the MRI protocol, including the parameters "synovial thickness", "thickness of the intra-articular effusion", "bone marrow edema", "cartilage changes" at Visit 9 (day 180 ± 4) compared with baseline at Visit 2 (Day 1).
Time frame: Baseline to month 6
Change in mean 100-mm visual analogue scale (VAS) in the target knee joint
Change in mean 100-mm VAS score at the target knee (pain in motion: at the start of the movement and while walking around the office) at Visit 3 (Day 7 ± 2), Visit 4 (Day 30 ± 2), Visit 5 (Day 60) ± 2), Visit 6 (day 90 ± 3) and Visit 9 (day 180 ± 4) compared to baseline at Visit 2 (day 1). VAS scores range from 0 ("no pain") to 100 ("the worst pain imaginable").
Time frame: Baseline to day 7, months 1, 2, 3, 6
Changing the circumference of the target knee joint
Change in target knee circumference at Visit 4 (Day 30 ± 2), Visit 6 (Day 90 ± 3), and Visit 9 (Day 180 ± 4) from baseline at Visit 2 (Day 1)
Time frame: Baseline to months 1, 3, 6
Change in the paracetamol intake
Patient diary assessment of total number of paracetamol tablets (500 mg dosage) taken since Day 1 (Visit 2, Day 1) and change in the number of patients (%) reporting consumption at Visit 3 (Day 7 ± 2), Visit 4 (Day 30 ± 2), Visit 5 (Day 60 ± 2), Visit 6 (Day 90 ± 3) and Visit 9 (Day 180 ± 4) compared to baseline at Visit 2 (Day 1);
Time frame: Baseline to day 7, months 1, 2, 3, 6
The number of cases of dropping out of patients (%) due to the ineffectiveness of therapy
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 paracetamol rescue drug at prescribed doses) or due to the need to increase the dose allowed under the protocol (1,500 mg per day: 3 tablets per day). 500 mg) paracetamol
Time frame: Baseline to month 6
Change in the mean score on the The Short Form-36 (SF-36) quality of life questionnaire
Change in Mean SF-36 Quality of Life Score at Visit 4 (Day 30 ± 2), Visit 6 (Day 90 ± 3), and Visit 9 (Day 180 ± 4) from Baseline at Visit 2 (Day 1). SF-36 results in eight domain scores. Each of them ranges from 0 to 100% with 100% indicating the best result possible.
Time frame: Baseline to months 1, 3, 6
Evaluation of the effectiveness of therapy by a doctor on the Integrative Medicine Outcome Scale (IMOS)
Evaluation of the effectiveness of therapy by a doctor at the end of the course of treatment (IMOS scale). Score ranges from 0 to 4 with 0 indicating the best result: complete recovery (0 points), significant improvement (1 point), slight to moderate improvement (2 points), no change (3 points), worsening (4 points).
Time frame: Baseline to month 6
Evaluation of the effectiveness of ongoing therapy by the patient according to the Integrative Medicine Outcome Scale (IMOS) scale
Evaluation of the effectiveness of the therapy by the patient on the IMOS scale. Score ranges from 0 to 3 with 0 indicating the best result: excellent (0 points), good (1 point), satisfactory (2 points), not effective (3 points).
Time frame: Baseline to month 6
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