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

Sponsor

NPO Petrovax (Industry)

Overall Status

Completed

CT.gov ID

NCT05975879

Collaborator

(none)

212

Enrollment

Locations

Arms

10.5

Actual Duration (Months)

17.7

Patients Per Site

1.7

Patients Per Site Per Month

Study Details

Study Description

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:

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.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis, Knee Osteoarthritis Knee Osteoarthritis Knee Arthritis Knee Discomfort Knee Pain Swelling Knee Pain Chronic	Dietary Supplement: undenaturated collagen type II, methylsulfonylmethane, boswellia serrata, vitamin D3 (cholecalciferol), vitamin C (ARTNEO) Dietary Supplement: Placebo	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

212 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Supportive Care

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

Actual Study Start Date :

May 31, 2022

Actual Primary Completion Date :

Feb 28, 2023

Actual Study Completion Date :

Apr 17, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: ARTNEO 1 capsule 1 time per day for 6 months	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.
Placebo Comparator: Placebo 1 capsule 1 time per day for 6 months	Dietary Supplement: Placebo Release form: capsules with an average weight of 585 mg. No active ingredients.

Arm

Intervention/Treatment

Active Comparator: ARTNEO

1 capsule 1 time per day for 6 months

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.

Placebo Comparator: Placebo

1 capsule 1 time per day for 6 months

Dietary Supplement: Placebo

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

Outcome Measures

Primary Outcome Measures

Change in WOMAC-T score [Baseline to month 6]
Change in total WOMAC score (WOMAC-T) at Visit 7 (Day 180 ± 4) from start of study dietary supplement/placebo compared to baseline (at Visit 2, Day 1).

Secondary Outcome Measures

Change in the mean score on the subscales of WOMAC [Baseline to months 1, 2, 3, 4, 6]
Change in the mean score on the subscales of 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);
Change in WOMAC-T score (expt month 6) [Baseline to months 1, 2, 3, 4]
Change in total WOMAC 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)
Change in KOOS [Baseline to months 1, 2, 3, 4, 6]
Changes in target joint functional state assessment according to KOOS (Knee injury and Osteoarthritis Outcome Score) 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);
Ibuprofen intake [Baseline to month 6]
Cumulative oral dose of ibuprofen since day 1 (Visit 2, day 1) and number of patients (%) reporting ibuprofen use;
Drop-out number [Baseline to month 6]
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;
EQ-5D assessment [Baseline to month 6]
Baseline EQ-5D Health Assessment (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)
Pain VAS assessment [Baseline to month 1, 2, 3, 4, 6]
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)

Other Outcome Measures

Synovitis severity [Baseline to month 6]
Assessing the severity of synovitis according to the results of ultrasound examination of the target knee joint from the basal level (Visit 2, Day 1) at Visit 7 (Day 180 ± 4)
14-day pain VAS assessment [Baseline to day 14]
Assessment of the severity of pain when walking in the target knee joint on a 100-mm visual analog scale (VAS) relative to the basal level (Visit 2, day 1) on day 14±1.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

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;
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;

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	NIMK Vashe Zdorovie LLC	Kazan	Russian Federation	420097
2	Federal State Budgetary Scientific Institution "Research Institute of Rheumatology named after V.A. Nasonova"	Moscow	Russian Federation	115522
3	Pirogov Russian National Research Medical University	Moscow	Russian Federation	117997
4	Research Center Eco-Safety LLC	Saint Petersburg	Russian Federation	191119
5	Energiia Zdoroviya LLC	Saint Petersburg	Russian Federation	194156
6	"Medical Sanitary Unit No. 157" LLC	Saint Petersburg	Russian Federation	196066
7	Research Center Eco-Safety LLC	Saint Petersburg	Russian Federation	196143
8	Zvezdnaya Clinic LLC	Saint Petersburg	Russian Federation	196158
9	Meili LLC	Saint Petersburg	Russian Federation	199397
10	State Health Institution "Tula Regional Clinical Dermatovenerologic Dispensary"	Tula	Russian Federation	300053
11	Ulyanovsk Regional Clinical Hospital	Ulyanovsk	Russian Federation	432017
12	Private educational institution of additional professional education 'Institute for advanced training and professional retraining of personnel	Yaroslavl	Russian Federation