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

NPO Petrovax1 site in 1 country70 target enrollmentMarch 21, 2022

ConditionsOsteoarthritis Osteo Arthritis Knee Osteoarthritis, Knee

InterventionsARTNEO Artra

DrugsArtra

Overview

Phase: Not Applicable
Intervention: ARTNEO
Conditions: Osteoarthritis
Sponsor: NPO Petrovax
Enrollment: 70
Locations: 1
Primary Endpoint: Change in the mean of the total score on The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scale
Status: Completed
Last Updated: 11 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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:

To evaluate the effectiveness of the supporting properties of dietary supplement ARTNEO (ARTNEO®) in patients with knee osteoarthritis in comparison with active control;
To evaluate the safety of the dietary supplement ARTNEO (ARTNEO®) in patients with knee osteoarthritis

Registry

clinicaltrials.gov

Start Date

March 21, 2022

End Date

July 18, 2023

Last Updated

11 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

NPO Petrovax

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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.)

Exclusion Criteria

•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)
•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

Arms & Interventions

ARTNEO

1 capsule 1 time per day for 6 months

Intervention: ARTNEO

Artra

1 tablet 2 times per day for 6 months

Intervention: Artra

Outcomes

Primary Outcomes

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

Change in total WOMAC score at Visit 9 (day 180 ± 4) from baseline at Visit 2 (day 1)

Secondary Outcomes

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)
Changing the circumference of the target knee joint(Baseline to months 1, 3, 6)
Change in the paracetamol intake(Baseline to day 7, months 1, 2, 3, 6)
The number of cases of dropping out of patients (%) due to the ineffectiveness of therapy(Baseline to month 6)
Change in the mean score on the The Short Form-36 (SF-36) quality of life questionnaire(Baseline to months 1, 3, 6)
Evaluation of the effectiveness of therapy by a doctor on the Integrative Medicine Outcome Scale (IMOS)(Baseline to month 6)
Evaluation of the effectiveness of ongoing therapy by the patient according to the Integrative Medicine Outcome Scale (IMOS) scale(Baseline to month 6)