NCT05975879

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:

  • 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
212

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2022

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 31, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 17, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 27, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 4, 2023

Completed
Last Updated

August 2, 2024

Status Verified

July 1, 2023

Enrollment Period

9 months

First QC Date

July 27, 2023

Last Update Submit

July 31, 2024

Conditions

Osteoarthritis, KneeOsteoarthritisKnee OsteoarthritisKnee ArthritisKnee DiscomfortKnee Pain SwellingKnee Pain Chronic

Keywords

undenatured type ii collagencollagenBoswellia serratamethylsulfonylmethaneosteoarthritisknee pain

Outcome Measures

Primary Outcomes (1)

  • Change in WOMAC-T score

    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).

    Baseline to month 6

Secondary Outcomes (7)

  • 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

  • Change in KOOS

    Baseline to months 1, 2, 3, 4, 6

  • Ibuprofen intake

    Baseline to month 6

  • Drop-out number

    Baseline to month 6

  • +2 more secondary outcomes

Other Outcomes (2)

  • Synovitis severity

    Baseline to month 6

  • 14-day pain VAS assessment

    Baseline to day 14

Study Arms (2)

ARTNEO

ACTIVE COMPARATOR

1 capsule 1 time per day for 6 months

Dietary Supplement: undenaturated collagen type II, methylsulfonylmethane, boswellia serrata, vitamin D3 (cholecalciferol), vitamin C (ARTNEO)

Placebo

PLACEBO COMPARATOR

1 capsule 1 time per day for 6 months

Dietary Supplement: Placebo

Interventions

undenaturated collagen type II, methylsulfonylmethane, boswellia serrata, vitamin D3 (cholecalciferol), vitamin C (ARTNEO)DIETARY_SUPPLEMENT

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.

ARTNEO
PlaceboDIETARY_SUPPLEMENT

Release form: capsules with an average weight of 585 mg. No active ingredients.

Placebo

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;
  • 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;
  • Ischemic heart disease, cerebrovascular disease in the acute stage or decompensation at the time of screening or according to medical history for the last 4 months before the screening visit;
  • Chronic obstructive pulmonary disease (COPD), bronchial asthma according to medical history;
  • Diagnosed moderate or severe chronic renal failure at the time of screening or based on medical history in the last 4 months prior to the screening visit;
  • Moderate to severe hepatic dysfunction as determined by history (any acute liver disease, toxic liver disease, cirrhosis, decompensated liver failure) at the time of screening or from medical history in the last 4 months prior to the screening visit;
  • The presence of rheumatological diseases according to the medical history;
  • Mental and / or neurological diseases with partial or complete loss of legal capacity;
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

NIMK Vashe Zdorovie LLC

Kazan', 420097, Russia

Location

Federal State Budgetary Scientific Institution "Research Institute of Rheumatology named after V.A. Nasonova"

Moscow, 115522, Russia

Location

Pirogov Russian National Research Medical University

Moscow, 117997, Russia

Location

Research Center Eco-Safety LLC

Saint Petersburg, 191119, Russia

Location

Energiia Zdoroviya LLC

Saint Petersburg, 194156, Russia

Location

"Medical Sanitary Unit No. 157" LLC

Saint Petersburg, 196066, Russia

Location

Research Center Eco-Safety LLC

Saint Petersburg, 196143, Russia

Location

Zvezdnaya Clinic LLC

Saint Petersburg, 196158, Russia

Location

Meili LLC

Saint Petersburg, 199397, Russia

Location

State Health Institution "Tula Regional Clinical Dermatovenerologic Dispensary"

Tula, 300053, Russia

Location

Ulyanovsk Regional Clinical Hospital

Ulyanovsk, 432017, Russia

Location

Private educational institution of additional professional education 'Institute for advanced training and professional retraining of personnel

Yaroslavl, Russia

Location

MeSH Terms

Conditions

Osteoarthritis, KneeOsteoarthritis

Interventions

dimethyl sulfoneFrankincenseCholecalciferolAscorbic Acid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Resins, PlantBiopolymersPolymersMacromolecular SubstancesPlant ExudatesBiological ProductsComplex MixturesCholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipidsSugar AcidsAcids, AcyclicCarboxylic AcidsOrganic ChemicalsHydroxy AcidsCarbohydrates

Study Officials

  • Ludmila Alekseeva, MD

    FSBSI "Research Institute of Rheumatology named after V.A. Nasonova"

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 27, 2023

First Posted

August 4, 2023

Study Start

May 31, 2022

Primary Completion

February 28, 2023

Study Completion

April 17, 2023

Last Updated

August 2, 2024

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

RU(12)