NCT05975879

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 212 (actual)
• Sponsor: NPO Petrovax · Industry
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

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: 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.

Conditions

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

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	undenaturated 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.
DIETARY_SUPPLEMENT	Placebo	Release form: capsules with an average weight of 585 mg. No active ingredients.

Timeline

• Start date: 2022-05-31
• Primary completion: 2023-02-28
• Completion: 2023-04-17
• First posted: 2023-08-04
• Last updated: 2024-08-02

Locations

12 sites across 1 country: Russia