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A Study of the Feasibility of Using the Dietary Supplement "ARTNEO" in Patients With Osteoathritis

CompletedNot applicableNCT05975879
View the official record on ClinicalTrials.gov

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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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: 1. 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; 2. 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.

Study details

Official title
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
Interventions
  • Dietary supplement: undenaturated collagen type II, methylsulfonylmethane, boswellia serrata, vitamin D3 (cholecalciferol), vitamin C (ARTNEO)
  • Dietary supplement: Placebo
Sponsor
NPO Petrovax
Start date
2022-05-31
Primary completion
2023-02-28
Sex
All
Age range
from 40 Years to 75 Years
Results posted
No results posted in this snapshot
Countries
Russia
Total sites listed
12

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: 1. Voluntarily signed informed consent to participate in the study; 2. Men and women in postmenopause, aged 40-75 years, capable of independent movement, BMI 18-30 kg/m2; 3. 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); 4. 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; 5. 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; 6. Ability to understand the rules of the study, willingness to follow them; 7. 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); 8. 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: 1. 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; 2. Intolerance to eggs, poultry, shellfish; 3. 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); 4. Coronary artery bypass grafting in medical history; 5. 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, u…

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05975879