- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03636035
Tregocel® as a Dietary Supplement in Mild Knee Osteoarthritis
September 17, 2022 updated by: Max Biocare Pty. Ltd.
Assessment of Performance of Participants With Mild Knee Osteoarthritis Taking Tregocel® as a Dietary Supplement Alongside Standard of Care Treatment
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.
Study Overview
Status
Completed
Conditions
Intervention / 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.
Study Type
Interventional
Enrollment (Actual)
150
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Warsaw, Poland
- Clinmed Pharma
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Tregocel® supplementation
Tregocel® coated tablets (2/day) orally for 36 weeks
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Coated tablet (oral)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in distance walked in 6-minutes as an indicator of AMBULATORY MOBILITY
Time Frame: Tested at Baseline (week 0) and at end of supplementation (week 36)
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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.
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Tested at Baseline (week 0) and at end of supplementation (week 36)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Physical exam parameter 1: BODY WEIGHT measurement
Time Frame: Screening (week -2), baseline (week 0); rescored at 12, 24, 36 and 40 weeks
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Body weight measure using digital scales (recorded in kilogram).
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Screening (week -2), baseline (week 0); rescored at 12, 24, 36 and 40 weeks
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Physical exam parameter 2: SUBJECT HEIGHT measurement
Time Frame: Screening (week -2), baseline (week 0); rescored at 12, 24, 36 and 40 weeks
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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]
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Screening (week -2), baseline (week 0); rescored at 12, 24, 36 and 40 weeks
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Vital sign 1: BODY TEMPERATURE
Time Frame: Screening (week -2), baseline (week 0); rescored at 12, 24, 36 and 40 weeks
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Measured using a digital ear thermometer after 5 minutes rest, sedentary.(recorded in degree Celsius)
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Screening (week -2), baseline (week 0); rescored at 12, 24, 36 and 40 weeks
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Vital sign 2: BLOOD PRESSURE
Time Frame: Screening (week -2), baseline (week 0); rescored at 12, 24, 36 and 40 weeks
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Systolic and diastolic blood pressure values will be determined using an automated sphygnomanometer after 5 minutes rest, sedentary (recorded in millimeter mercury).
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Screening (week -2), baseline (week 0); rescored at 12, 24, 36 and 40 weeks
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Vital sign 3: PULSE RATE
Time Frame: Screening (week -2), baseline (week 0); rescored at 12, 24, 36 and 40 weeks
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Recorded using an automated sphygnomanometer after 5 minutes rest, sedentary (beats / minute)
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Screening (week -2), baseline (week 0); rescored at 12, 24, 36 and 40 weeks
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Arthritis self-assessment 1: Initial degree of PERCEIVED PAIN represented by manual marking on a simplified printed 100mm linear scale (during Run-in)
Time Frame: Run-in period (week -1 to week 0)
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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)
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Run-in period (week -1 to week 0)
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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
Time Frame: Scores taken at baseline (week 0); rescored at 12, 24, 36 and 40 weeks
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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.
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Scores taken at baseline (week 0); rescored at 12, 24, 36 and 40 weeks
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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.
Time Frame: Scores taken at baseline (0 week); rescored at 12, 24, 36 and 40 weeks
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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).
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Scores taken at baseline (0 week); rescored at 12, 24, 36 and 40 weeks
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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.
Time Frame: Scores taken at baseline (week 0); rescored at 12, 24, 36 and 40 weeks
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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).
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Scores taken at baseline (week 0); rescored at 12, 24, 36 and 40 weeks
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Change in target KNEE FLEXIBILITY assessment, based on heel-thigh distance and knee angle at maximal flexion.
Time Frame: Scores taken supine and prone for both knees at baseline (week 0); rescored at 12, 24, 36 weeks
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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.
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Scores taken supine and prone for both knees at baseline (week 0); rescored at 12, 24, 36 weeks
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Safety assessment 1: clinical HEMATOLOGY parameters (a) Blood cell count
Time Frame: Performed at screening (week -2), baseline (week 0); rescored at 12, 24, 36 and 40 weeks
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Number erythrocytes leukocytes and platelets initially and changes thereafter determined using an automated blood sample analyser (number x 10^9/litre)
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Performed at screening (week -2), baseline (week 0); rescored at 12, 24, 36 and 40 weeks
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Safety assessment 1: clinical HEMATOLOGY parameters (b) hemoglobin level
Time Frame: Performed at screening (week -2), baseline (week 0); rescored at 12, 24, 36 and 40 weeks
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Hemoglobin will be measured initially and any subsequent changes determined using UV/Vis spectrometry (g/dL).
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Performed at screening (week -2), baseline (week 0); rescored at 12, 24, 36 and 40 weeks
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Safety assessment 1: clinical HEMATOLOGY parameters (c) sodium level
Time Frame: Performed at screening (week -2), baseline (week 0); rescored at 12, 24, 36 and 40 weeks
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Blood sodium initially and any subsequent changes to be determined using a blood gas analyser (mM)
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Performed at screening (week -2), baseline (week 0); rescored at 12, 24, 36 and 40 weeks
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Safety assessment 1: clinical HEMATOLOGY parameters (d) potassium level
Time Frame: Performed at screening (week -2), baseline (week 0); rescored at 12, 24, 36 and 40 weeks
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Blood sodium initially and any subsequent changes to be determined using a blood gas analyser (mM)
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Performed at screening (week -2), baseline (week 0); rescored at 12, 24, 36 and 40 weeks
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Safety assessment 1: clinical HEMATOLOGY parameters (e) aspartate alanine transferase level
Time Frame: Performed at screening (week -2), baseline (week 0); rescored at 12, 24, 36 and 40 weeks
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Blood aspartate alanine transferase initially and any subsequent changes to be determined using ELISA assay (IU/L)
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Performed at screening (week -2), baseline (week 0); rescored at 12, 24, 36 and 40 weeks
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Safety assessment 1: clinical HEMATOLOGY parameters (f) alanine aminotransferase
Time Frame: Performed at screening (week -2), baseline (week 0); rescored at 12, 24, 36 and 40 weeks
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Blood alanine aminotransferase level initially and any subsequent changes to be determined using ELISA assay (IU/L)
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Performed at screening (week -2), baseline (week 0); rescored at 12, 24, 36 and 40 weeks
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Safety assessment 1: clinical HEMATOLOGY parameters (g) total bilirubin level
Time Frame: Performed at screening (week -2), baseline (week 0); rescored at 12, 24, 36 and 40 weeks
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Blood bilirubin initially and any subsequent changes to be determined using ELISA assay (IU/L).
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Performed at screening (week -2), baseline (week 0); rescored at 12, 24, 36 and 40 weeks
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Safety assessment 1: clinical HEMATOLOGY parameters (h) alkaline phosphatase level
Time Frame: Performed at screening (week -2), baseline (week 0); rescored at 12, 24, 36 and 40 weeks
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Alkaline phosphatase level initially and any subsequent changes to be determined using ELISA assay (IU/L).
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Performed at screening (week -2), baseline (week 0); rescored at 12, 24, 36 and 40 weeks
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Safety assessment 1: clinical HEMATOLOGY parameters (i) creatine level
Time Frame: Performed at screening (week -2), baseline (week 0); rescored at 12, 24, 36 and 40 weeks
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Creatine level initially and any subsequent changes to be determined using ELISA assay (IU/L).
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Performed at screening (week -2), baseline (week 0); rescored at 12, 24, 36 and 40 weeks
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Safety assessment 1: clinical HEMATOLOGY parameters (j) blood sodium
Time Frame: Performed at screening (week -2), baseline (week 0); rescored at 12, 24, 36 and 40 weeks
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Sodium level initially and any subsequent changes to be determined using a blood gas analyser (mM).
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Performed at screening (week -2), baseline (week 0); rescored at 12, 24, 36 and 40 weeks
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Safety assessment 1: clinical HEMATOLOGY parameters (k) blood potassium
Time Frame: Performed at screening (week -2), baseline (week 0); rescored at 12, 24, 36 and 40 weeks
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Potassium level initially and any subsequent changes to be determined using a blood gas analyser (mM).
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Performed at screening (week -2), baseline (week 0); rescored at 12, 24, 36 and 40 weeks
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Safety assessment 2: URINALYSIS (a) presence of leukocytes
Time Frame: Performed at screening (week -2), baseline (Week 0); rescored at 12, 24, 36 and 40 weeks
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Urine will be dipstick tested initially and any subsequent changes determined colorimetrically (negative = grey, positive = increase in purple color intensity).
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Performed at screening (week -2), baseline (Week 0); rescored at 12, 24, 36 and 40 weeks
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Safety assessment 2: URINALYSIS (b) presence of nitrites
Time Frame: Performed at screening (week -2), baseline (Week 0); rescored at 12, 24, 36 and 40 weeks
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Urine will be dipstick tested initially and any subsequent changes determined colorimetrically (negative = yellow, positive = increase in pink color intensity).
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Performed at screening (week -2), baseline (Week 0); rescored at 12, 24, 36 and 40 weeks
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Safety assessment 2: URINALYSIS (c) level of urobilinogen
Time Frame: Performed at screening (week -2), baseline (Week 0); rescored at 12, 24, 36 and 40 weeks
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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).
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Performed at screening (week -2), baseline (Week 0); rescored at 12, 24, 36 and 40 weeks
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Safety assessment 2: URINALYSIS (d) presence of protein
Time Frame: Performed at screening (week -2), baseline (Week 0); rescored at 12, 24, 36 and 40 weeks
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Urine will be dipstick tested initially and any subsequent changes determined colorimetrically (none or trace amounts (quince); raised = increased darkness of green pigment)
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Performed at screening (week -2), baseline (Week 0); rescored at 12, 24, 36 and 40 weeks
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Safety assessment 2: URINALYSIS (e) pH
Time Frame: Performed at screening (week -2), baseline (Week 0); rescored at 12, 24, 36 and 40 weeks
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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).
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Performed at screening (week -2), baseline (Week 0); rescored at 12, 24, 36 and 40 weeks
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Safety assessment 2: URINALYSIS (f) presence of blood
Time Frame: Performed at screening (week -2), baseline (Week 0); rescored at 12, 24, 36 and 40 weeks
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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).
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Performed at screening (week -2), baseline (Week 0); rescored at 12, 24, 36 and 40 weeks
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Safety assessment 2: URINALYSIS (g) specific gravity (SG)
Time Frame: Performed at screening (week -2), baseline (Week 0); rescored at 12, 24, 36 and 40 weeks
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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.
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Performed at screening (week -2), baseline (Week 0); rescored at 12, 24, 36 and 40 weeks
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Safety assessment 2: URINALYSIS (h) ketone level
Time Frame: Performed at screening (week -2), baseline (Week 0); rescored at 12, 24, 36 and 40 weeks
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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)
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Performed at screening (week -2), baseline (Week 0); rescored at 12, 24, 36 and 40 weeks
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Safety assessment 2: URINALYSIS (i) presence of bilirubin
Time Frame: Performed at screening (week -2), baseline (Week 0); rescored at 12, 24, 36 and 40 weeks
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Urine will be dipstick tested initially and any subsequent changes determined colorimetrically (negative = yellow; increasing levels correlate with appearance of light brown pigment).
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Performed at screening (week -2), baseline (Week 0); rescored at 12, 24, 36 and 40 weeks
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Safety assessment 2: URINALYSIS (j) glucose level
Time Frame: Performed at screening (week -2), baseline (Week 0); rescored at 12, 24, 36 and 40 weeks
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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).
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Performed at screening (week -2), baseline (Week 0); rescored at 12, 24, 36 and 40 weeks
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Safety assessment 2: URINALYSIS (k) presence of human chorionic gonadotrophin (hCG)
Time Frame: Performed at screening (week -2), baseline (Week 0); rescored at 12, 24, 36 and 40 weeks
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Urine will be dipstick tested and measured colorimetrically for presence of hCG (positive test = appearance of blue line on white background; negative = remains white).
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Performed at screening (week -2), baseline (Week 0); rescored at 12, 24, 36 and 40 weeks
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Determination of total usage of PRESCRIPTION ANALGESICS
Time Frame: Screening (week -2), baseline (week 0); rescored at 12, 24, 36 and 40 weeks
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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).
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Screening (week -2), baseline (week 0); rescored at 12, 24, 36 and 40 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Krzysztof Wilczek, MD, Coramed, Wroklaw
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2019
Primary Completion (Actual)
June 30, 2020
Study Completion (Actual)
June 30, 2020
Study Registration Dates
First Submitted
August 8, 2018
First Submitted That Met QC Criteria
August 15, 2018
First Posted (Actual)
August 17, 2018
Study Record Updates
Last Update Posted (Actual)
September 21, 2022
Last Update Submitted That Met QC Criteria
September 17, 2022
Last Verified
February 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MBTR01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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