Multicenter, Prospective, Double-blind, Placebo-controlled, Randomized Study of the Feasibility of Using the Dietary Supplement "ARTNEO®", Capsules for Oral Administration in Patients With Stage II-III Primary Knee Osteoarthritis

NPO Petrovax11 sites in 1 country212 target enrollmentMay 31, 2022

ConditionsOsteoarthritis, Knee Osteoarthritis Knee Osteoarthritis Knee Arthritis Knee Discomfort Knee Pain Swelling Knee Pain Chronic

Overview

Phase: N/A
Intervention: Not specified
Conditions: Osteoarthritis, Knee
Sponsor: NPO Petrovax
Enrollment: 212
Locations: 11
Primary Endpoint: Change in WOMAC-T score
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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:

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;
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.

Registry

clinicaltrials.gov

Start Date

May 31, 2022

End Date

April 17, 2023

Last Updated

last year

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 in postmenopause, aged 40-75 years, capable of independent movement, BMI 18-30 kg/m2;
•Verified primary gonarthrosis according to the American College of Rheumatology criteria at least 6 months before enrollment in the study (in the presence of pain in the knee joint and radiological signs of gonarthrosis in combination with one of the following signs: crepitus in the joint or morning stiffness in the joint for less than 30 min);
•II-III radiological stage of gonarthrosis according to the Kellgren-Lawrence classification with a predominant lesion of the medial tibiofemoral area of the knee joint;
•Severity of pain in the assessed knee joint at the time of the screening visit from 40 or more on 100-mm VAS while walking;
•Ability to understand the rules of the study, willingness to follow them;
•Willingness to limit the diet (soy, avocado, passion fruit, pineapple, turmeric, linseed, rapeseed, soybean oils, chia seeds, walnuts, decoction of willow bark, pine, wormwood, L-carnitine, etc. should be excluded);
•Consent of the men during the study and within 30 days after its completion to use the methods of contraception described in the protocol of this study.

Exclusion Criteria

•Individual intolerance to the active or excipients of the ARTNEO® dietary supplement (undenatured type II collagen + methylsulfonylmethane + Boswellia serrata extract + vitamin C + Vitamin D3), placebo and the "rescue" drug ibuprofen;
•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);
•Coronary artery bypass grafting in medical history;
•Diseases, the presence of which, from the point of view of the research physician, puts the patient's health at risk in case of participation in the study or potentially complicates the interpretation of 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;
•History of gouty arthritis;
•Malabsorption syndrome, celiac disease, short bowel syndrome, intestinal lymphangiectasia;
•Peptic ulcer of the stomach and duodenum (in the acute phase or in the acute stage), gastrointestinal bleeding, Crohn's disease, ulcerative colitis at the time of screening or according to medical history for the last 4 months before the screening visit;
•Hemophilia, hemorrhagic diathesis at the time of screening or according to medical history for the last 4 months before the screening visit, constant use of anticoagulants and antiplatelet agents according to the medical history for the last 4 months before the screening visit;

Outcomes

Primary Outcomes

Change in WOMAC-T score

Time Frame: Baseline to month 6

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).

Secondary Outcomes

Pain VAS assessment(Baseline to month 1, 2, 3, 4, 6)
Change in the mean score on the subscales of WOMAC(Baseline to months 1, 2, 3, 4, 6)
Change in WOMAC-T score (expt month 6)(Baseline to months 1, 2, 3, 4)
EQ-5D assessment(Baseline to month 6)
Change in KOOS(Baseline to months 1, 2, 3, 4, 6)
Ibuprofen intake(Baseline to month 6)
Drop-out number(Baseline to month 6)