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

NCT06032442 | Completed

• 1 other identifier: ArtNeo-terra
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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. The main questions it aims to answer are:

1. 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. 2.To evaluate the safety of the dietary supplement ARTNEO (ARTNEO®) in patients with knee osteoarthritis

Conditions

Osteoarthritis; Osteo Arthritis Knee; Osteoarthritis, Knee

Keywords

undenatured type ii collagen; collagen; Boswellia serrata; methylsulfonylmethane; osteoarthritis; knee pain

Outcome Measures

Primary Outcomes (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)

  Baseline to month 6

Secondary Outcomes (11)

• Change in mean WOMAC total score (baseline to day 7, months 1 and 3)

  Baseline to day 7, months 1 and 3

• Change in the mean on the subscales of the WOMAC (scales of pain, stiffness, functional insufficiency)

  Baseline to day 7, months 1, 3, 6

• Change in the mean score on the Lequesne scale

  Baseline to day 7, months 1, 3, 6

• Evaluation of magnetic resonance imaging (MRI) signs of damage to the target joint

  Baseline to month 6

• Change in mean 100-mm visual analogue scale (VAS) in the target knee joint

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

Study Arms (2)

ARTNEO

EXPERIMENTAL

1 capsule 1 time per day for 6 months

Dietary Supplement: ARTNEO

Artra

ACTIVE COMPARATOR

1 tablet 2 times per day for 6 months

Drug: Artra

Interventions

ARTNEO DIETARY_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.

ARTNEO

Artra DRUG

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.

Artra

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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))
• 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)

You may not qualify if:

• 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;
• 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)
• 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

Sponsors & Collaborators

• NPO Petrovax: lead

Study Sites (1)

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, Russia

Location

MeSH Terms

Conditions

Osteoarthritis; Osteoarthritis, Knee

Interventions

hydroquinone

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Vadim Mazurov, MD

  North-Western State Medical University named after I.I.Mechnikov

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2023
• First Posted: September 13, 2023
• Study Start: March 21, 2022
• Primary Completion: May 18, 2023
• Study Completion: July 18, 2023
• Last Updated: June 3, 2025

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)