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

NCT05975879 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 212

Last updated 2024-08-02

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • NPO Petrovax

    lead INDUSTRY

Principal Investigators

  • Ludmila Alekseeva, MD · FSBSI "Research Institute of Rheumatology named after V.A. Nasonova"

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-31
Primary Completion
2023-02-28
Completion
2023-04-17

Countries

  • Russia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05975879 on ClinicalTrials.gov