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

Primary Purpose

Osteoarthritis, Knee, Osteoarthritis, Knee Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
undenaturated collagen type II, methylsulfonylmethane, boswellia serrata, vitamin D3 (cholecalciferol), vitamin C (ARTNEO)
Placebo
Sponsored by
NPO Petrovax
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Osteoarthritis, Knee focused on measuring undenatured type ii collagen, collagen, Boswellia serrata, methylsulfonylmethane, osteoarthritis, knee pain

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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;

Sites / Locations

  • NIMK Vashe Zdorovie LLC
  • Federal State Budgetary Scientific Institution "Research Institute of Rheumatology named after V.A. Nasonova"
  • Pirogov Russian National Research Medical University
  • Research Center Eco-Safety LLC
  • Energiia Zdoroviya LLC
  • "Medical Sanitary Unit No. 157" LLC
  • Research Center Eco-Safety LLC
  • Zvezdnaya Clinic LLC
  • Meili LLC
  • State Health Institution "Tula Regional Clinical Dermatovenerologic Dispensary"
  • Ulyanovsk Regional Clinical Hospital
  • Private educational institution of additional professional education 'Institute for advanced training and professional retraining of personnel

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

ARTNEO

Placebo

Arm Description

1 capsule 1 time per day for 6 months

1 capsule 1 time per day for 6 months

Outcomes

Primary Outcome Measures

Change in WOMAC-T score
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
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)
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
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
Cumulative oral dose of ibuprofen since day 1 (Visit 2, day 1) and number of patients (%) reporting ibuprofen use;
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;
EQ-5D assessment
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
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)

Full Information

First Posted
July 27, 2023
Last Updated
August 3, 2023
Sponsor
NPO Petrovax
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1. Study Identification

Unique Protocol Identification Number
NCT05975879
Brief Title
A Study of the Feasibility of Using the Dietary Supplement "ARTNEO" in Patients With Osteoathritis
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
May 31, 2022 (Actual)
Primary Completion Date
February 28, 2023 (Actual)
Study Completion Date
April 17, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NPO Petrovax

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee, Osteoarthritis, Knee Osteoarthritis, Knee Arthritis, Knee Discomfort, Knee Pain Swelling, Knee Pain Chronic
Keywords
undenatured type ii collagen, collagen, Boswellia serrata, methylsulfonylmethane, osteoarthritis, knee pain

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
212 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ARTNEO
Arm Type
Active Comparator
Arm Description
1 capsule 1 time per day for 6 months
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
1 capsule 1 time per day for 6 months
Intervention Type
Dietary Supplement
Intervention Name(s)
undenaturated collagen type II, methylsulfonylmethane, boswellia serrata, vitamin D3 (cholecalciferol), vitamin C (ARTNEO)
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Release form: capsules with an average weight of 585 mg. No active ingredients.
Primary Outcome Measure Information:
Title
Change in WOMAC-T score
Description
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).
Time Frame
Baseline to month 6
Secondary Outcome Measure Information:
Title
Change in the mean score on the subscales of WOMAC
Description
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);
Time Frame
Baseline to months 1, 2, 3, 4, 6
Title
Change in WOMAC-T score (expt month 6)
Description
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)
Time Frame
Baseline to months 1, 2, 3, 4
Title
Change in KOOS
Description
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);
Time Frame
Baseline to months 1, 2, 3, 4, 6
Title
Ibuprofen intake
Description
Cumulative oral dose of ibuprofen since day 1 (Visit 2, day 1) and number of patients (%) reporting ibuprofen use;
Time Frame
Baseline to month 6
Title
Drop-out number
Description
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;
Time Frame
Baseline to month 6
Title
EQ-5D assessment
Description
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)
Time Frame
Baseline to month 6
Title
Pain VAS assessment
Description
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)
Time Frame
Baseline to month 1, 2, 3, 4, 6
Other Pre-specified Outcome Measures:
Title
Synovitis severity
Description
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)
Time Frame
Baseline to month 6
Title
14-day pain VAS assessment
Description
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.
Time Frame
Baseline to day 14

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ludmila Alekseeva, MD
Organizational Affiliation
FSBSI "Research Institute of Rheumatology named after V.A. Nasonova"
Official's Role
Principal Investigator
Facility Information:
Facility Name
NIMK Vashe Zdorovie LLC
City
Kazan
ZIP/Postal Code
420097
Country
Russian Federation
Facility Name
Federal State Budgetary Scientific Institution "Research Institute of Rheumatology named after V.A. Nasonova"
City
Moscow
ZIP/Postal Code
115522
Country
Russian Federation
Facility Name
Pirogov Russian National Research Medical University
City
Moscow
ZIP/Postal Code
117997
Country
Russian Federation
Facility Name
Research Center Eco-Safety LLC
City
Saint Petersburg
ZIP/Postal Code
191119
Country
Russian Federation
Facility Name
Energiia Zdoroviya LLC
City
Saint Petersburg
ZIP/Postal Code
194156
Country
Russian Federation
Facility Name
"Medical Sanitary Unit No. 157" LLC
City
Saint Petersburg
ZIP/Postal Code
196066
Country
Russian Federation
Facility Name
Research Center Eco-Safety LLC
City
Saint Petersburg
ZIP/Postal Code
196143
Country
Russian Federation
Facility Name
Zvezdnaya Clinic LLC
City
Saint Petersburg
ZIP/Postal Code
196158
Country
Russian Federation
Facility Name
Meili LLC
City
Saint Petersburg
ZIP/Postal Code
199397
Country
Russian Federation
Facility Name
State Health Institution "Tula Regional Clinical Dermatovenerologic Dispensary"
City
Tula
ZIP/Postal Code
300053
Country
Russian Federation
Facility Name
Ulyanovsk Regional Clinical Hospital
City
Ulyanovsk
ZIP/Postal Code
432017
Country
Russian Federation
Facility Name
Private educational institution of additional professional education 'Institute for advanced training and professional retraining of personnel
City
Yaroslavl
Country
Russian Federation

12. IPD Sharing Statement

Plan to Share IPD
No

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

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