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OsteoarthritisNCT06032442

A Study to Assess Efficacy of Supporting Properties and Safety of ARTNEO in Patients With Knee Osteoarthritis

A study testing ARTNEO and Artra in people with Osteoarthritis and Osteo Arthritis Knee, run by NPO Petrovax at 1 site in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 40 to 75 years
What is being tested?
ARTNEO and Artra
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteRussia
Study dates
21 Mar 2022to 18 Jul 2023
Phase
Interventional
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Voluntarily signed informed consent to participate in the study
  • Men and women aged 40-75 years old, able to move independently, BMI 18-35 kg/m2
  • Verified osteoarthritis involving the target knee according to the American College of Rheumatology (ACR) criteria at least 3 months prior to study entry, i.e. pain in the knee joint in combination with one of the following signs: crepitus in the joint or morning stiffness in the joint lasting less than 30 minutes in association with radiographic findings in the target knee joint
  • X-ray stage I-III osteoarthritis in the target knee joint according to the Kellgren-Lawrence classification with a predominant lesion of the medial tibiofemoral area of the knee joint (X-ray of the target knee joint during the screening period or within 6 months prior to the screening visit)
  • Regular associated pain in the target knee joint within the last 3 months
  • Pain severity from 45 to 74 mm (moderate pain) on 100 mm VAS in the target knee joint after a washout screening period and confirmation of a 48-hour complete abstinence from rescue therapy (pain in motion (when starting a movement and walking around the office))
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  • Lequesne score of 5-7 for the joint being assessed after a washout screening period and confirmation of 48 hours of complete abstinence from rescue therapy;
  • The ability to understand the rules of the study, the willingness to follow them, as well as the ability and ability to go through the procedures provided for in the study;
  • Willingness to avoid the use of ibuprofen, aspirin (>100 mg/day), and other NSAIDs or other pain medications (OTC and prescription) other than paracetamol as a "rescue drug" throughout the study (maximum dosage allowed per protocol) 1,500 mg per day, with a complete withdrawal required 48 hours before Visits 2 - 6 and Visit 9)
  • Willingness to refuse complementary and alternative medicine therapy, as well as willingness to restrict diet (excluded soy, avocado, passion fruit, pineapple, turmeric, foods enriched with ω-3 fatty acids, decoction of willow bark, pine, mugwort, L-carnitine, acupuncture and etc.)
  • Women of childbearing potential must have a negative pregnancy test at screening (except women who have had a hysterectomy or who have gone through menopause for more than 2 years)

Who cannot join

  • Pregnancy, lactation or planning pregnancy during the study period
  • Individual intolerance to the active or excipients of the dietary supplement ARTNEO (non-denatured type II collagen + methylsulfonylmethane + Boswellia serrata extract + vitamin C + Vitamin D3), the reference drug and the "rescue drug" paracetamol (acetaminophen)
  • 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)
  • Positive test results for HIV, viral hepatitis B or C, syphilis.
  • Diseases that, from the point of view of the investigator, put the patient's health at risk if participating in the study or potentially make it difficult to interpret the results of the study (may affect the assessment of endpoints)
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  • Known or suspected malignancy at the time of screening or in the previous 2 years, other than completely healed skin cancer in situ;
  • Immune-inflammatory joint disease, systemic connective tissue disease, or severe osteoarthritis (target joint after washout screening period and 48-hour complete withdrawal of rescue drug, motion VAS score > 74 mm and/or Lequesne score > 7 points), systemic red lupus
  • History of gout
  • Diseases of the gastrointestinal tract: enteritis, colitis, Crohn's disease, irritable bowel syndrome, ulcerative colitis and any other diseases of the gastrointestinal tract, which, in the doctor's opinion, may affect the absorption and assimilation of the active components of the drugs, in particular, the formation of the mechanism of oral immunotolerance to undenatured collagen
  • Hemophilia and other hemorrhagic diathesis, as well as taking anticoagulants and antiplatelet agents
  • Fibromyalgia and other chronic pain syndromes
  • Impaired kidney function (GFR less than 60 ml / min / 1.73 m2 as assessed by the Cockcroft-Gault formula at the screening visit), severe chronic renal failure
  • Severe liver dysfunction (ALT, AST levels 3 times or more above the upper limit of normal, and / or total bilirubin level 1.5 times or more above the upper limit of normal)
  • 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 in the target knee joint:
  • Hyaluronates - less than 6 months prior to randomization
  • Other high molecular weight synovial fluid prostheses in less than 24 months
  • Glucocorticosteroids - less than 1 month prior to randomization visit
  • NSAIDs less than 3 weeks before randomization
  • The need for stable use of glucocorticosteroids in any dosage form
  • Failure to comply with the washout screening period and 48 hours of complete withdrawal of the rescue drug (immediately prior to baseline measurement at Visit 2, Day 1) in relation to prohibited therapy, in particular the use of paracetamol, ibuprofen, aspirin or other NSAIDs, any pain medication in any drug form, as well as some natural products (such as soy, avocado, passion fruit, pineapple, turmeric, products enriched with ω-3 fatty acids, decoction of willow bark, pine, wormwood), L-carnitine
  • Use of glucocorticosteroids, SYSADOA (Symptomatic Slow-Acting Drugs in Osteoarthritis) in the period of 3 months before randomization
  • Use of ω-3 polyunsaturated fatty acid preparations in the 6 months prior to randomization (a 2-week washout period is allowed), therapeutic doses of fish or vegetable oils (≥ 2 g/day), shark cartilage preparations
  • Participation in another clinical study at present or in the previous 30 days or 5 half-lives (whichever is longer) prior to the Screening Visit
  • History of treatment with oral undenatured type II collagen or anti-tumor necrosis factor (TNF) antibodies

Trial locations and contacts

1 site in 1 country.

Russia1 site

  • 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, 191015

Other trials in Russia

About this study

Official title: An Open Randomized Prospective Study of the Supporting Properties of the Dietary Supplement ARTNEO in Comparison With Active Control in Parallel Groups in Patients With Knee Osteoarthritis Aged 40 to 75 Years

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
Being tested
ARTNEO, Artra
Keywords
undenatured type ii collagen, collagen, Boswellia serrata, methylsulfonylmethane, osteoarthritis, knee pain
Medical subject headings
Osteoarthritis, Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ARTNEODietary supplement

    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.

  • ArtraDrug

    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.

Study groups in NCT06032442
Study groupRoleWhat they receive
ARTNEOExperimental1 capsule 1 time per day for 6 months
Receives: Dietary Supplement: ARTNEO
ArtraActive comparator1 tablet 2 times per day for 6 months
Receives: Drug: Artra

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: Baseline to month 6

Secondary outcomes (11)

  1. 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)

    Measured: Baseline to day 7, months 1 and 3

  2. 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)

    Measured: Baseline to day 7, months 1, 3, 6

  3. 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)

    Measured: Baseline to day 7, months 1, 3, 6

  4. 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).

    Measured: Baseline to month 6

  5. 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").

    Measured: Baseline to day 7, months 1, 2, 3, 6

  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)

    Measured: Baseline to months 1, 3, 6

  7. 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);

    Measured: Baseline to day 7, months 1, 2, 3, 6

  8. 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

    Measured: Baseline to month 6

  9. 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.

    Measured: Baseline to months 1, 3, 6

  10. 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).

    Measured: Baseline to month 6

  11. 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).

    Measured: Baseline to month 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Sep 2023
  2. Study start21 Mar 2022
  3. Primary completion18 May 2023
  4. Study completion18 Jul 2023

Resources

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 N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06032442
Sponsor's protocol ID
ArtNeo-terra
Status last verified
Aug 2023
First submitted
4 Sep 2023
Last updated
3 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing ARTNEO and Artra in people with Osteoarthritis and Osteo Arthritis Knee, run by NPO Petrovax at 1 site in Russia.

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 11 inclusion and 27 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 3 Jun 2025. 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 Russia. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

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?

Change in the mean of the total score on The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scale (time frame: Baseline to month 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06032442.

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 3 Jun 2025.

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