Osteoarthritis, KneeNCT05975879

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

A study testing undenaturated collagen type II, methylsulfonylmethane, boswellia serrata, vitamin D3 (cholecalciferol), vitamin C (ARTNEO) in people with Osteoarthritis, Knee and Osteoarthritis, run by NPO Petrovax at 12 sites in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 40 to 75 years
Conditions the study is for: Osteoarthritis, Knee, Osteoarthritis, Knee Osteoarthritis
What is being tested?: undenaturated collagen type II, methylsulfonylmethane, boswellia serrata, vitamin D3 (cholecalciferol), vitamin C (ARTNEO)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 212 participants
Where: 12 sitesRussia
Study dates: 31 May 2022to 17 Apr 2023
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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;

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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;
Presence or suspicion of drug, alcohol or drug addiction;
Intra-articular injection into the target knee joint:
Hyaluronates - less than 6 months prior to randomization;
Glucocorticosteroids less than 1 month prior to the randomization visit.
PRP therapy - less than 6 months prior to randomization
The need for constant use of glucocorticoids in any dosage form;
Use, including single use, of paracetamol, NSAIDs in any dosage form, and other pain medications within the last 48 hours prior to the randomization visit. Use within 7 days before randomization of certain natural products (such as soy, avocado, passion fruit, pineapple, turmeric, linseed, rapeseed, soybean oils, chia seeds, walnuts, decoction of willow bark, pine, mugwort), L-carnitine;
The use of glucosamine or chondroitin during the last 3 months before randomization with a course duration of more than 3 months (if the duration of the course of glucosamine or chondroitin was less than 3 months, then this therapy must be abandoned throughout the study from the moment of the screening visit);
Use of ω-3 polyunsaturated fatty acid preparations within 14 days prior to randomization, therapeutic doses of fish oils (≥ 2 g/day) and shark cartilage preparations within 6 months prior to randomization (except vitamin D3);
Participation in any clinical trial currently or in the previous 30 days or 5 half-lives (whichever is longer) prior to the Screening visit;
History of oral undenatured type II collagen therapy in the last 4 months prior to the screening visit;

Trial locations and contacts

12 sites in 1 country.

City, postcode or hospital

12 sites in 1 country

Russia12 sites

NIMK Vashe Zdorovie LLC
Kazan', 420097
Federal State Budgetary Scientific Institution "Research Institute of Rheumatology named after V.A. Nasonova"
Moscow, 115522
Pirogov Russian National Research Medical University
Moscow, 117997
Research Center Eco-Safety LLC
Saint Petersburg, 191119
Energiia Zdoroviya LLC
Saint Petersburg, 194156
"Medical Sanitary Unit No. 157" LLC
Saint Petersburg, 196066
Research Center Eco-Safety LLC
Saint Petersburg, 196143
Zvezdnaya Clinic LLC
Saint Petersburg, 196158
Meili LLC
Saint Petersburg, 199397
State Health Institution "Tula Regional Clinical Dermatovenerologic Dispensary"
Tula, 300053
Ulyanovsk Regional Clinical Hospital
Ulyanovsk, 432017
Private educational institution of additional professional education 'Institute for advanced training and professional retraining of personnel
Yaroslavl

Other trials in Russia

About this study

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

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.

Conditions: Osteoarthritis, Knee, Osteoarthritis, Knee Osteoarthritis, Knee Arthritis, Knee Discomfort, Knee Pain Swelling
Being tested: undenaturated collagen type II, methylsulfonylmethane, boswellia serrata, vitamin D3 (cholecalciferol), vitamin C (ARTNEO), Placebo
Keywords: undenatured type ii collagen, collagen, Boswellia serrata, methylsulfonylmethane, osteoarthritis, knee pain
Medical subject headings: Osteoarthritis, Knee, Osteoarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT05975879
Study group	Role	What they receive
ARTNEO	Active comparator	1 capsule 1 time per day for 6 months Receives: 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 Receives: Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: Baseline to month 6

Secondary outcomes (7)

Change in the mean score on the subscales of WOMAC
Change in the mean score on the subscales of Western Ontario and McMaster University Osteoarthritis Index (WOMAC) (pain, stiffness, functional impairment) at Visit 3 (day 30 ± 2), Visit 4 (day 60 ± 2), Visit 5 (day 90 ± 3), Visit 6 (day 120 ± 3) ) and Visit 7 (Day 180 ± 4) compared to baseline (at Visit 2, Day 1);
Measured: Baseline to months 1, 2, 3, 4, 6
Change in WOMAC-T score (expt month 6)
Change in total Western Ontario and McMaster University Osteoarthritis Index score (WOMAC-T) at Visit 3 (day 30 ± 2), Visit 4 (day 60 ± 2), Visit 5 (day 90 ± 3), Visit 6 (day 120 ± 3) compared to basal value (on Visit 2, day 1)
Measured: Baseline to months 1, 2, 3, 4
Change in KOOS
Changes in target joint functional state assessment according to Knee injury and Osteoarthritis Outcome Score (KOOS) at Visit 3 (day 30 ± 2), Visit 4 (day 60 ± 2), Visit 5 (day 90 ± 3), Visit 6 (day 120 ± 3) and Visit 7 (day 180 ± 4) compared to baseline (at Visit 2, day 1);
Measured: Baseline to months 1, 2, 3, 4, 6
Ibuprofen intake
Cumulative oral dose of ibuprofen since day 1 (Visit 2, day 1) and number of patients (%) reporting ibuprofen use;
Measured: Baseline to month 6
Drop-out number
The number of patients dropping out (%) due to the need to prescribe non-steroidal anti-inflammatory drugs (NSAIDs) and other pain medications (with the exception of the drug "rescue" ibuprofen in the doses established by the protocol) or the need to increase the dose allowed under the protocol (more than 1200 mg / day) of ibuprofen;
Measured: Baseline to month 6
EQ-5D assessment
European Quality of Life Questionnaire (EQ-5D) Health Assessment from Baseline (Visit 2, Day 1) at Visit 3 (Day 30 ± 2), Visit 4 (Day 60 ± 2), Visit 5 (Day 90 ± 3), Visit 6 (day 120 ± 3) and Visit 7 (day 180 ± 4)
Measured: Baseline to month 6
Pain VAS assessment
Pain assessment in the target knee on 100 mm visual analog scale (VAS) relative to baseline (Visit 2, Day 1) at Visit 3 (Day 30 ± 2), Visit 4 (Day 60 ± 2), Visit 5 (day 90 ± 3), Visit 6 (day 120 ± 3) and Visit 7 (day 180 ± 4)
Measured: Baseline to month 1, 2, 3, 4, 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 May 202217 Apr 2023

First posted4 Aug 2023
Study start31 May 2022
Primary completion28 Feb 2023
Study completion17 Apr 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 212 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05975879
Sponsor's protocol ID: Artneo_2021
Status last verified: Jul 2023
First submitted: 27 Jul 2023
Last updated: 2 Aug 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Osteoarthritis, Knee trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT05975879
Acronym / sponsor ID: Artneo_2021
Conditions: Osteoarthritis, Knee, Osteoarthritis, Knee Osteoarthritis, Knee Arthritis, Knee Discomfort, Knee Pain Swelling
Keywords: undenatured type ii collagen, collagen, Boswellia serrata, methylsulfonylmethane, osteoarthritis, knee pain
Study type: Interventional
Recruitment status: Completed
Enrolment: 212 participants (actual)
Lead sponsor: NPO PetrovaxIndustry (pharma, biotech, devices)
Study start: 31 May 2022 (actual)
Primary completion: 28 Feb 2023 (actual)
Study completion: 17 Apr 2023 (actual)
First posted: 4 Aug 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
ARTNEO	Active comparator	Dietary Supplement: undenaturated collagen type II, methylsulfonylmethane, boswellia serrata, vitamin D3 (cholecalciferol), vitamin C (ARTNEO)1 capsule 1 time per day for 6 months
Placebo	Placebo comparator	Dietary Supplement: Placebo1 capsule 1 time per day for 6 months

Who may qualify

Ages: 40 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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;

Key exclusion criteria (27 listed)

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):

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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	ARTNEO
PlaceboRelease form: capsules with an average weight of 585 mg. No active ingredients.	Dietary supplement	Placebo

Primary outcome

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).

7 secondary outcomes

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2024.
Individual participant dataSharing planned: No

Related trials for Osteoarthritis, Knee

Not yet recruiting
Holistic Healing for Knee Osteoarthritis
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Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
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Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ludmila Alekseeva, MD principal investigator

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

12 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in WOMAC-T score (time frame: Baseline to month 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05975879.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2024.