Back to resultsTregocel® as a Dietary Supplement in Mild Knee Osteoarthritis
Primary Purpose
Mild Knee Osteoarthritis
Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Tregocel®
Sponsored by
About this trial
This is an interventional supportive care trial for Mild Knee Osteoarthritis focused on measuring dietary supplement, arthritis, joint, complementary medicine
Eligibility Criteria
Inclusion Criteria:
- Compliance with all study procedures
- Fulfilment of consent process
- Documented diagnosis of radiologically confirmed mild knee osteoarthritis with stable pain management (including patello-femoral joint, Kellgren-Lawrence classification ≤2 and clinical symptoms lasting more than 6 months prior to screening)
- Maximal pain score ≥30 on a 100 mm VAS at screening and confirmed at baseline, with PRN use of analgesics during run-in
- Completed patient diary during run-in
- Ambulant with ECOG score <2
Exclusion Criteria:
- pregnancy or breastfeeding (women)
- body mass index less than 18.5 kg/m^2 or more than 35.0 kg/m^2.
- secondary knee OA
- clinically apparent tense effusion of the target knee
- valgus/varus knee/foot deformities, ligament laxity, or meniscal instability
- changes in regular OA therapy during screening
- chronic diseases which may require treatment with systemic steroids
- progressive serious medical conditions
- severe organ dysfunction
- cardiac insufficiency
- history of gastrointestinal ulcer or bleeding.
- any significant medical conditions that may interfere with the study procedures, safety, compliance or overall participation in the study
- allergies or intolerance to any of the dietary supplement ingredients
Sites / Locations
- Clinmed Pharma
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Tregocel® supplementation
Arm Description
Tregocel® coated tablets (2/day) orally for 36 weeks
Outcomes
Primary Outcome Measures
Change in distance walked in 6-minutes as an indicator of AMBULATORY MOBILITY
Challenge involves subject walking unimpeded along a continuous straight line of 30 metre in distance with no incline. Distance covered will by an assistant sured with a 30 metre metric tape measure. Laps and time will be tracked manually with a digital lap counter and timer (second). Baseline values will be compared to values after supplementation to determine any change in individual performance.
Secondary Outcome Measures
Physical exam parameter 1: BODY WEIGHT measurement
Body weight measure using digital scales (recorded in kilogram).
Physical exam parameter 2: SUBJECT HEIGHT measurement
Body height measured manually using a wall tape measure (recorded in metre). Weight and height values will be used to calculate body mass index [weight (kilogram) / height (metre) ^2]
Vital sign 1: BODY TEMPERATURE
Measured using a digital ear thermometer after 5 minutes rest, sedentary.(recorded in degree Celsius)
Vital sign 2: BLOOD PRESSURE
Systolic and diastolic blood pressure values will be determined using an automated sphygnomanometer after 5 minutes rest, sedentary (recorded in millimeter mercury).
Vital sign 3: PULSE RATE
Recorded using an automated sphygnomanometer after 5 minutes rest, sedentary (beats / minute)
Arthritis self-assessment 1: Initial degree of PERCEIVED PAIN represented by manual marking on a simplified printed 100mm linear scale (during Run-in)
Subject responds to a request to report maximal pain experienced in 48 hours in target knee by pen or pencil marking along a 100mm line scale (0mm (left) = no pain; 100mm (right) = extreme pain; marks closer to right indicate more pain). Length from 0mm to mark will be measured using a 300mm ruler, to indicate the degree of maximal pain felt. No subscales are included in this assessment. Marks appearing between centre of the line and 100mm limit are considered moderate to severe (total score range = 0-100mm)
Arthritis self-assessment 2: change in degree of PERCEIVED PAIN represented by manual marking on a printed 100mm linear scale (During and after supplementation) in response to WOMAC questionnaire
Subject responds to a request to report degree of pain experienced in 48 hours in target knee by pen or pencil marking along a 100mm horizontal line (0mm (left) = no pain; 100mm (right) = extreme pain; more pain = closer to right hand end of line). Length from 0mm to mark will be measured using a 300mm ruler. Report includes degree of pain felt while stationary or during normal movement (a set of 5 subscales appearing as separate lines with the same limits). Marks appearing between the centre of the line and 100mm limit are considered between moderate and severe, with more severe toward the right. Total score is a sum of the 5 subscales (range 0-500mm). WOMAC = Western Ontario and McMaster Universities Arthritis index.
Arthritis self-assessment 3: change in degree of PERCEIVED STIFFNESS represented by manual marking on a printed 100mm linear scale (During and after supplementation) in response to WOMAC questionnaire.
Subject responds to a request to report feeling of stiffness experienced in 48 hours in target knee by pen or pencil marking along a 100mm horizontal line (0mm (left) = no stiffness; 100mm (right) = extreme stiffness; more pain = closer to right hand end of line). Length from 0mm to mark will be measured using a 300mm ruler, to indicate the degree of stiffness felt at start and end of a day (a set of 2 subscales, appearing as separate lines with the same limits). Marks appearing from the centre of the line to 100mm limit are considered between moderate and severe, with more severe toward the right. Total score is a sum of the 2 subscales (range 0-200mm).
Arthritis self-assessment 4: change in degree of PERCEIVED DIFFICULTY WITH DAILY TASKS represented by manual marking on a printed 100mm linear scale (During and after supplementation) in response to WOMAC questionnaire.
Subject responds to a request to report difficult in performing daily tasks in 48 hours due to arthritis in target knee by pen or pencil marking along a 100mm horizontal line (0mm (left) = no pain; 100mm (right) = extreme pain; more pain = closer to right hand end of line). Length from 0mm to mark will be measured using a 300mm ruler, to indicate the degree of difficulty experienced in different domestic activities (set of 17 subscales, appearing as separate lines with the same limits). Marks appearing between the centre of the line to 100mm limit are considered between moderate and severe, with more severe toward the right. Total score is a sum of the 17 subscales (range 0-1700mm).
Change in target KNEE FLEXIBILITY assessment, based on heel-thigh distance and knee angle at maximal flexion.
Subjects will lie either supine or prone while holding their target knee statically as close to their thigh as is bearable. Distance from heal to thigh (standard tape measurement) and angle of knee (measured using a goniometer) will be recorded.
Safety assessment 1: clinical HEMATOLOGY parameters (a) Blood cell count
Number erythrocytes leukocytes and platelets initially and changes thereafter determined using an automated blood sample analyser (number x 10^9/litre)
Safety assessment 1: clinical HEMATOLOGY parameters (b) hemoglobin level
Hemoglobin will be measured initially and any subsequent changes determined using UV/Vis spectrometry (g/dL).
Safety assessment 1: clinical HEMATOLOGY parameters (c) sodium level
Blood sodium initially and any subsequent changes to be determined using a blood gas analyser (mM)
Safety assessment 1: clinical HEMATOLOGY parameters (d) potassium level
Blood sodium initially and any subsequent changes to be determined using a blood gas analyser (mM)
Safety assessment 1: clinical HEMATOLOGY parameters (e) aspartate alanine transferase level
Blood aspartate alanine transferase initially and any subsequent changes to be determined using ELISA assay (IU/L)
Safety assessment 1: clinical HEMATOLOGY parameters (f) alanine aminotransferase
Blood alanine aminotransferase level initially and any subsequent changes to be determined using ELISA assay (IU/L)
Safety assessment 1: clinical HEMATOLOGY parameters (g) total bilirubin level
Blood bilirubin initially and any subsequent changes to be determined using ELISA assay (IU/L).
Safety assessment 1: clinical HEMATOLOGY parameters (h) alkaline phosphatase level
Alkaline phosphatase level initially and any subsequent changes to be determined using ELISA assay (IU/L).
Safety assessment 1: clinical HEMATOLOGY parameters (i) creatine level
Creatine level initially and any subsequent changes to be determined using ELISA assay (IU/L).
Safety assessment 1: clinical HEMATOLOGY parameters (j) blood sodium
Sodium level initially and any subsequent changes to be determined using a blood gas analyser (mM).
Safety assessment 1: clinical HEMATOLOGY parameters (k) blood potassium
Potassium level initially and any subsequent changes to be determined using a blood gas analyser (mM).
Safety assessment 2: URINALYSIS (a) presence of leukocytes
Urine will be dipstick tested initially and any subsequent changes determined colorimetrically (negative = grey, positive = increase in purple color intensity).
Safety assessment 2: URINALYSIS (b) presence of nitrites
Urine will be dipstick tested initially and any subsequent changes determined colorimetrically (negative = yellow, positive = increase in pink color intensity).
Safety assessment 2: URINALYSIS (c) level of urobilinogen
Urine will be dipstick tested initially and any subsequent changes determined colorimetrically (normal = 0.2-1 mg/dL, yellow; raised = 2-8 mg/dL, with increasing pink intensity).
Safety assessment 2: URINALYSIS (d) presence of protein
Urine will be dipstick tested initially and any subsequent changes determined colorimetrically (none or trace amounts (quince); raised = increased darkness of green pigment)
Safety assessment 2: URINALYSIS (e) pH
Urine will be dipstick tested initially and any subsequent changes determined colorimetrically (dual pigment assay, represented by color change from fading of orange (pH 5) to increased darkness of green pigment (pH 8.5).
Safety assessment 2: URINALYSIS (f) presence of blood
Urine will be dipstick tested initially and any subsequent changes determined colorimetrically (none = yellow; trace amounts of non-hemolysed blood (dark-green speckle discoloration on a yellow background); presence of hemolysed blood (increasing darkness of green pigment on yellow background).
Safety assessment 2: URINALYSIS (g) specific gravity (SG)
Urine will be dipstick tested initially and any subsequent changes determined colorimetrically (Dark green = 1.000, yellow-green = 1.030; increasing SG correlates with decreasing darkness of green pigment.
Safety assessment 2: URINALYSIS (h) ketone level
Urine will be dipstick tested initially and any subsequent changes determined colorimetrically (none = beige; trace (pink = 5, increasing to large (160) mg/dL with increasing darkness of burgundy pigment)
Safety assessment 2: URINALYSIS (i) presence of bilirubin
Urine will be dipstick tested initially and any subsequent changes determined colorimetrically (negative = yellow; increasing levels correlate with appearance of light brown pigment).
Safety assessment 2: URINALYSIS (j) glucose level
Urine will be dipstick tested and measured, and subsequent changes determined colorimetrically for content of glucose (absence = blue-green; presence = range form 100 (green) to > 2000 mg/dL (dark brown).
Safety assessment 2: URINALYSIS (k) presence of human chorionic gonadotrophin (hCG)
Urine will be dipstick tested and measured colorimetrically for presence of hCG (positive test = appearance of blue line on white background; negative = remains white).
Determination of total usage of PRESCRIPTION ANALGESICS
Usage of any analgesics will be recorded on a daily basis by subjects using diary, which will be reviewed at clinical consultation. Total consumption will be logged at the end of the supplemention period as an indicator of changes in reliance on prescribed medications. (expressed as number of medications per day, regardless of type).
Full Information
NCT ID
NCT03636035
First Posted
August 8, 2018
Last Updated
September 17, 2022
Sponsor
Max Biocare Pty. Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03636035
Brief Title
Tregocel® as a Dietary Supplement in Mild Knee Osteoarthritis
Official Title
Assessment of Performance of Participants With Mild Knee Osteoarthritis Taking Tregocel® as a Dietary Supplement Alongside Standard of Care Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
June 30, 2020 (Actual)
Study Completion Date
June 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Max Biocare Pty. Ltd.
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
This study is an assessment of the overall performance of participants with symptomatic mild knee OA taking Tregocel® as a dietary supplement in addition to standard of care treatment.
Detailed Description
Tregocel® is a combination herbal product which as a dietary supplementation may help maintain proper performance of joints. Although some studies have reported beneficial effects for individual components of Tregocel®, there have been no clinical assessments of supplementation with Tregocel® as a finished product. This study will involve collection of data on Tregocel® supplementation in participants with symptomatic mild knee osteoarthritis (OA) who are already receiving standard pharmacological treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Knee Osteoarthritis
Keywords
dietary supplement, arthritis, joint, complementary medicine
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tregocel® supplementation
Arm Type
Experimental
Arm Description
Tregocel® coated tablets (2/day) orally for 36 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Tregocel®
Intervention Description
Coated tablet (oral)
Primary Outcome Measure Information:
Title
Change in distance walked in 6-minutes as an indicator of AMBULATORY MOBILITY
Description
Challenge involves subject walking unimpeded along a continuous straight line of 30 metre in distance with no incline. Distance covered will by an assistant sured with a 30 metre metric tape measure. Laps and time will be tracked manually with a digital lap counter and timer (second). Baseline values will be compared to values after supplementation to determine any change in individual performance.
Time Frame
Tested at Baseline (week 0) and at end of supplementation (week 36)
Secondary Outcome Measure Information:
Title
Physical exam parameter 1: BODY WEIGHT measurement
Description
Body weight measure using digital scales (recorded in kilogram).
Time Frame
Screening (week -2), baseline (week 0); rescored at 12, 24, 36 and 40 weeks
Title
Physical exam parameter 2: SUBJECT HEIGHT measurement
Description
Body height measured manually using a wall tape measure (recorded in metre). Weight and height values will be used to calculate body mass index [weight (kilogram) / height (metre) ^2]
Time Frame
Screening (week -2), baseline (week 0); rescored at 12, 24, 36 and 40 weeks
Title
Vital sign 1: BODY TEMPERATURE
Description
Measured using a digital ear thermometer after 5 minutes rest, sedentary.(recorded in degree Celsius)
Time Frame
Screening (week -2), baseline (week 0); rescored at 12, 24, 36 and 40 weeks
Title
Vital sign 2: BLOOD PRESSURE
Description
Systolic and diastolic blood pressure values will be determined using an automated sphygnomanometer after 5 minutes rest, sedentary (recorded in millimeter mercury).
Time Frame
Screening (week -2), baseline (week 0); rescored at 12, 24, 36 and 40 weeks
Title
Vital sign 3: PULSE RATE
Description
Recorded using an automated sphygnomanometer after 5 minutes rest, sedentary (beats / minute)
Time Frame
Screening (week -2), baseline (week 0); rescored at 12, 24, 36 and 40 weeks
Title
Arthritis self-assessment 1: Initial degree of PERCEIVED PAIN represented by manual marking on a simplified printed 100mm linear scale (during Run-in)
Description
Subject responds to a request to report maximal pain experienced in 48 hours in target knee by pen or pencil marking along a 100mm line scale (0mm (left) = no pain; 100mm (right) = extreme pain; marks closer to right indicate more pain). Length from 0mm to mark will be measured using a 300mm ruler, to indicate the degree of maximal pain felt. No subscales are included in this assessment. Marks appearing between centre of the line and 100mm limit are considered moderate to severe (total score range = 0-100mm)
Time Frame
Run-in period (week -1 to week 0)
Title
Arthritis self-assessment 2: change in degree of PERCEIVED PAIN represented by manual marking on a printed 100mm linear scale (During and after supplementation) in response to WOMAC questionnaire
Description
Subject responds to a request to report degree of pain experienced in 48 hours in target knee by pen or pencil marking along a 100mm horizontal line (0mm (left) = no pain; 100mm (right) = extreme pain; more pain = closer to right hand end of line). Length from 0mm to mark will be measured using a 300mm ruler. Report includes degree of pain felt while stationary or during normal movement (a set of 5 subscales appearing as separate lines with the same limits). Marks appearing between the centre of the line and 100mm limit are considered between moderate and severe, with more severe toward the right. Total score is a sum of the 5 subscales (range 0-500mm). WOMAC = Western Ontario and McMaster Universities Arthritis index.
Time Frame
Scores taken at baseline (week 0); rescored at 12, 24, 36 and 40 weeks
Title
Arthritis self-assessment 3: change in degree of PERCEIVED STIFFNESS represented by manual marking on a printed 100mm linear scale (During and after supplementation) in response to WOMAC questionnaire.
Description
Subject responds to a request to report feeling of stiffness experienced in 48 hours in target knee by pen or pencil marking along a 100mm horizontal line (0mm (left) = no stiffness; 100mm (right) = extreme stiffness; more pain = closer to right hand end of line). Length from 0mm to mark will be measured using a 300mm ruler, to indicate the degree of stiffness felt at start and end of a day (a set of 2 subscales, appearing as separate lines with the same limits). Marks appearing from the centre of the line to 100mm limit are considered between moderate and severe, with more severe toward the right. Total score is a sum of the 2 subscales (range 0-200mm).
Time Frame
Scores taken at baseline (0 week); rescored at 12, 24, 36 and 40 weeks
Title
Arthritis self-assessment 4: change in degree of PERCEIVED DIFFICULTY WITH DAILY TASKS represented by manual marking on a printed 100mm linear scale (During and after supplementation) in response to WOMAC questionnaire.
Description
Subject responds to a request to report difficult in performing daily tasks in 48 hours due to arthritis in target knee by pen or pencil marking along a 100mm horizontal line (0mm (left) = no pain; 100mm (right) = extreme pain; more pain = closer to right hand end of line). Length from 0mm to mark will be measured using a 300mm ruler, to indicate the degree of difficulty experienced in different domestic activities (set of 17 subscales, appearing as separate lines with the same limits). Marks appearing between the centre of the line to 100mm limit are considered between moderate and severe, with more severe toward the right. Total score is a sum of the 17 subscales (range 0-1700mm).
Time Frame
Scores taken at baseline (week 0); rescored at 12, 24, 36 and 40 weeks
Title
Change in target KNEE FLEXIBILITY assessment, based on heel-thigh distance and knee angle at maximal flexion.
Description
Subjects will lie either supine or prone while holding their target knee statically as close to their thigh as is bearable. Distance from heal to thigh (standard tape measurement) and angle of knee (measured using a goniometer) will be recorded.
Time Frame
Scores taken supine and prone for both knees at baseline (week 0); rescored at 12, 24, 36 weeks
Title
Safety assessment 1: clinical HEMATOLOGY parameters (a) Blood cell count
Description
Number erythrocytes leukocytes and platelets initially and changes thereafter determined using an automated blood sample analyser (number x 10^9/litre)
Time Frame
Performed at screening (week -2), baseline (week 0); rescored at 12, 24, 36 and 40 weeks
Title
Safety assessment 1: clinical HEMATOLOGY parameters (b) hemoglobin level
Description
Hemoglobin will be measured initially and any subsequent changes determined using UV/Vis spectrometry (g/dL).
Time Frame
Performed at screening (week -2), baseline (week 0); rescored at 12, 24, 36 and 40 weeks
Title
Safety assessment 1: clinical HEMATOLOGY parameters (c) sodium level
Description
Blood sodium initially and any subsequent changes to be determined using a blood gas analyser (mM)
Time Frame
Performed at screening (week -2), baseline (week 0); rescored at 12, 24, 36 and 40 weeks
Title
Safety assessment 1: clinical HEMATOLOGY parameters (d) potassium level
Description
Blood sodium initially and any subsequent changes to be determined using a blood gas analyser (mM)
Time Frame
Performed at screening (week -2), baseline (week 0); rescored at 12, 24, 36 and 40 weeks
Title
Safety assessment 1: clinical HEMATOLOGY parameters (e) aspartate alanine transferase level
Description
Blood aspartate alanine transferase initially and any subsequent changes to be determined using ELISA assay (IU/L)
Time Frame
Performed at screening (week -2), baseline (week 0); rescored at 12, 24, 36 and 40 weeks
Title
Safety assessment 1: clinical HEMATOLOGY parameters (f) alanine aminotransferase
Description
Blood alanine aminotransferase level initially and any subsequent changes to be determined using ELISA assay (IU/L)
Time Frame
Performed at screening (week -2), baseline (week 0); rescored at 12, 24, 36 and 40 weeks
Title
Safety assessment 1: clinical HEMATOLOGY parameters (g) total bilirubin level
Description
Blood bilirubin initially and any subsequent changes to be determined using ELISA assay (IU/L).
Time Frame
Performed at screening (week -2), baseline (week 0); rescored at 12, 24, 36 and 40 weeks
Title
Safety assessment 1: clinical HEMATOLOGY parameters (h) alkaline phosphatase level
Description
Alkaline phosphatase level initially and any subsequent changes to be determined using ELISA assay (IU/L).
Time Frame
Performed at screening (week -2), baseline (week 0); rescored at 12, 24, 36 and 40 weeks
Title
Safety assessment 1: clinical HEMATOLOGY parameters (i) creatine level
Description
Creatine level initially and any subsequent changes to be determined using ELISA assay (IU/L).
Time Frame
Performed at screening (week -2), baseline (week 0); rescored at 12, 24, 36 and 40 weeks
Title
Safety assessment 1: clinical HEMATOLOGY parameters (j) blood sodium
Description
Sodium level initially and any subsequent changes to be determined using a blood gas analyser (mM).
Time Frame
Performed at screening (week -2), baseline (week 0); rescored at 12, 24, 36 and 40 weeks
Title
Safety assessment 1: clinical HEMATOLOGY parameters (k) blood potassium
Description
Potassium level initially and any subsequent changes to be determined using a blood gas analyser (mM).
Time Frame
Performed at screening (week -2), baseline (week 0); rescored at 12, 24, 36 and 40 weeks
Title
Safety assessment 2: URINALYSIS (a) presence of leukocytes
Description
Urine will be dipstick tested initially and any subsequent changes determined colorimetrically (negative = grey, positive = increase in purple color intensity).
Time Frame
Performed at screening (week -2), baseline (Week 0); rescored at 12, 24, 36 and 40 weeks
Title
Safety assessment 2: URINALYSIS (b) presence of nitrites
Description
Urine will be dipstick tested initially and any subsequent changes determined colorimetrically (negative = yellow, positive = increase in pink color intensity).
Time Frame
Performed at screening (week -2), baseline (Week 0); rescored at 12, 24, 36 and 40 weeks
Title
Safety assessment 2: URINALYSIS (c) level of urobilinogen
Description
Urine will be dipstick tested initially and any subsequent changes determined colorimetrically (normal = 0.2-1 mg/dL, yellow; raised = 2-8 mg/dL, with increasing pink intensity).
Time Frame
Performed at screening (week -2), baseline (Week 0); rescored at 12, 24, 36 and 40 weeks
Title
Safety assessment 2: URINALYSIS (d) presence of protein
Description
Urine will be dipstick tested initially and any subsequent changes determined colorimetrically (none or trace amounts (quince); raised = increased darkness of green pigment)
Time Frame
Performed at screening (week -2), baseline (Week 0); rescored at 12, 24, 36 and 40 weeks
Title
Safety assessment 2: URINALYSIS (e) pH
Description
Urine will be dipstick tested initially and any subsequent changes determined colorimetrically (dual pigment assay, represented by color change from fading of orange (pH 5) to increased darkness of green pigment (pH 8.5).
Time Frame
Performed at screening (week -2), baseline (Week 0); rescored at 12, 24, 36 and 40 weeks
Title
Safety assessment 2: URINALYSIS (f) presence of blood
Description
Urine will be dipstick tested initially and any subsequent changes determined colorimetrically (none = yellow; trace amounts of non-hemolysed blood (dark-green speckle discoloration on a yellow background); presence of hemolysed blood (increasing darkness of green pigment on yellow background).
Time Frame
Performed at screening (week -2), baseline (Week 0); rescored at 12, 24, 36 and 40 weeks
Title
Safety assessment 2: URINALYSIS (g) specific gravity (SG)
Description
Urine will be dipstick tested initially and any subsequent changes determined colorimetrically (Dark green = 1.000, yellow-green = 1.030; increasing SG correlates with decreasing darkness of green pigment.
Time Frame
Performed at screening (week -2), baseline (Week 0); rescored at 12, 24, 36 and 40 weeks
Title
Safety assessment 2: URINALYSIS (h) ketone level
Description
Urine will be dipstick tested initially and any subsequent changes determined colorimetrically (none = beige; trace (pink = 5, increasing to large (160) mg/dL with increasing darkness of burgundy pigment)
Time Frame
Performed at screening (week -2), baseline (Week 0); rescored at 12, 24, 36 and 40 weeks
Title
Safety assessment 2: URINALYSIS (i) presence of bilirubin
Description
Urine will be dipstick tested initially and any subsequent changes determined colorimetrically (negative = yellow; increasing levels correlate with appearance of light brown pigment).
Time Frame
Performed at screening (week -2), baseline (Week 0); rescored at 12, 24, 36 and 40 weeks
Title
Safety assessment 2: URINALYSIS (j) glucose level
Description
Urine will be dipstick tested and measured, and subsequent changes determined colorimetrically for content of glucose (absence = blue-green; presence = range form 100 (green) to > 2000 mg/dL (dark brown).
Time Frame
Performed at screening (week -2), baseline (Week 0); rescored at 12, 24, 36 and 40 weeks
Title
Safety assessment 2: URINALYSIS (k) presence of human chorionic gonadotrophin (hCG)
Description
Urine will be dipstick tested and measured colorimetrically for presence of hCG (positive test = appearance of blue line on white background; negative = remains white).
Time Frame
Performed at screening (week -2), baseline (Week 0); rescored at 12, 24, 36 and 40 weeks
Title
Determination of total usage of PRESCRIPTION ANALGESICS
Description
Usage of any analgesics will be recorded on a daily basis by subjects using diary, which will be reviewed at clinical consultation. Total consumption will be logged at the end of the supplemention period as an indicator of changes in reliance on prescribed medications. (expressed as number of medications per day, regardless of type).
Time Frame
Screening (week -2), baseline (week 0); rescored at 12, 24, 36 and 40 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Compliance with all study procedures
Fulfilment of consent process
Documented diagnosis of radiologically confirmed mild knee osteoarthritis with stable pain management (including patello-femoral joint, Kellgren-Lawrence classification ≤2 and clinical symptoms lasting more than 6 months prior to screening)
Maximal pain score ≥30 on a 100 mm VAS at screening and confirmed at baseline, with PRN use of analgesics during run-in
Completed patient diary during run-in
Ambulant with ECOG score <2
Exclusion Criteria:
pregnancy or breastfeeding (women)
body mass index less than 18.5 kg/m^2 or more than 35.0 kg/m^2.
secondary knee OA
clinically apparent tense effusion of the target knee
valgus/varus knee/foot deformities, ligament laxity, or meniscal instability
changes in regular OA therapy during screening
chronic diseases which may require treatment with systemic steroids
progressive serious medical conditions
severe organ dysfunction
cardiac insufficiency
history of gastrointestinal ulcer or bleeding.
any significant medical conditions that may interfere with the study procedures, safety, compliance or overall participation in the study
allergies or intolerance to any of the dietary supplement ingredients
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Krzysztof Wilczek, MD
Organizational Affiliation
Coramed, Wroklaw
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinmed Pharma
City
Warsaw
Country
Poland
12. IPD Sharing Statement
Citations:
PubMed Identifier
34725289
Citation
Zegota Z, Gozdzik J, Glogowska-Szelag J. IMPROVED PHYSICAL FUNCTION WITH COMPLEMENTARY USE OF A DIETARY SUPPLEMENT FOR MILD KNEE OSTEOARTHRITIS: A SUBGROUP ANALYSIS. Wiad Lek. 2021;74(9 cz 1):2128-2137.
Results Reference
derived
Learn more about this trial
Tregocel® as a Dietary Supplement in Mild Knee Osteoarthritis
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