Mild Knee OsteoarthritisNCT03636035
Tregocel® as a Dietary Supplement in Mild Knee Osteoarthritis
A study testing Tregocel® in people with Mild Knee Osteoarthritis, run by Max Biocare Pty. Ltd. at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Mild Knee Osteoarthritis
- What is being tested?
- Tregocel®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jan 2019to 30 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Mild Knee Osteoarthritis
- Being tested
- Tregocel®
- Keywords
- dietary supplement, arthritis, joint, complementary medicine
- Medical subject headings
- Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tregocel®Dietary supplement
Coated tablet (oral)
| Study group | Role | What they receive |
|---|---|---|
| Tregocel® supplementation | Experimental | Tregocel® coated tablets (2/day) orally for 36 weeks Receives: Dietary Supplement: Tregocel® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Tested at Baseline (week 0) and at end of supplementation (week 36)
Secondary outcomes (33)
Physical exam parameter 1: BODY WEIGHT measurement
Body weight measure using digital scales (recorded in kilogram).
Measured: Screening (week -2), baseline (week 0); rescored at 12, 24, 36 and 40 weeks
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]
Measured: Screening (week -2), baseline (week 0); rescored at 12, 24, 36 and 40 weeks
Vital sign 1: BODY TEMPERATURE
Measured using a digital ear thermometer after 5 minutes rest, sedentary.(recorded in degree Celsius)
Measured: Screening (week -2), baseline (week 0); rescored at 12, 24, 36 and 40 weeks
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).
Measured: Screening (week -2), baseline (week 0); rescored at 12, 24, 36 and 40 weeks
Vital sign 3: PULSE RATE
Recorded using an automated sphygnomanometer after 5 minutes rest, sedentary (beats / minute)
Measured: Screening (week -2), baseline (week 0); rescored at 12, 24, 36 and 40 weeks
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)
Measured: Run-in period (week -1 to week 0)
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.
Measured: Scores taken at baseline (week 0); rescored at 12, 24, 36 and 40 weeks
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).
Measured: Scores taken at baseline (0 week); rescored at 12, 24, 36 and 40 weeks
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).
Measured: Scores taken at baseline (week 0); rescored at 12, 24, 36 and 40 weeks
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.
Measured: Scores taken supine and prone for both knees at baseline (week 0); rescored at 12, 24, 36 weeks
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)
Measured: Performed at screening (week -2), baseline (week 0); rescored at 12, 24, 36 and 40 weeks
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).
Measured: Performed at screening (week -2), baseline (week 0); rescored at 12, 24, 36 and 40 weeks
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)
Measured: Performed at screening (week -2), baseline (week 0); rescored at 12, 24, 36 and 40 weeks
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)
Measured: Performed at screening (week -2), baseline (week 0); rescored at 12, 24, 36 and 40 weeks
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)
Measured: Performed at screening (week -2), baseline (week 0); rescored at 12, 24, 36 and 40 weeks
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)
Measured: Performed at screening (week -2), baseline (week 0); rescored at 12, 24, 36 and 40 weeks
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).
Measured: Performed at screening (week -2), baseline (week 0); rescored at 12, 24, 36 and 40 weeks
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).
Measured: Performed at screening (week -2), baseline (week 0); rescored at 12, 24, 36 and 40 weeks
Safety assessment 1: clinical HEMATOLOGY parameters (i) creatine level
Creatine level initially and any subsequent changes to be determined using ELISA assay (IU/L).
Measured: Performed at screening (week -2), baseline (week 0); rescored at 12, 24, 36 and 40 weeks
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).
Measured: Performed at screening (week -2), baseline (week 0); rescored at 12, 24, 36 and 40 weeks
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).
Measured: Performed at screening (week -2), baseline (week 0); rescored at 12, 24, 36 and 40 weeks
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).
Measured: Performed at screening (week -2), baseline (Week 0); rescored at 12, 24, 36 and 40 weeks
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).
Measured: Performed at screening (week -2), baseline (Week 0); rescored at 12, 24, 36 and 40 weeks
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).
Measured: Performed at screening (week -2), baseline (Week 0); rescored at 12, 24, 36 and 40 weeks
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)
Measured: Performed at screening (week -2), baseline (Week 0); rescored at 12, 24, 36 and 40 weeks
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).
Measured: Performed at screening (week -2), baseline (Week 0); rescored at 12, 24, 36 and 40 weeks
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).
Measured: Performed at screening (week -2), baseline (Week 0); rescored at 12, 24, 36 and 40 weeks
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.
Measured: Performed at screening (week -2), baseline (Week 0); rescored at 12, 24, 36 and 40 weeks
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)
Measured: Performed at screening (week -2), baseline (Week 0); rescored at 12, 24, 36 and 40 weeks
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).
Measured: Performed at screening (week -2), baseline (Week 0); rescored at 12, 24, 36 and 40 weeks
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).
Measured: Performed at screening (week -2), baseline (Week 0); rescored at 12, 24, 36 and 40 weeks
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).
Measured: Performed at screening (week -2), baseline (Week 0); rescored at 12, 24, 36 and 40 weeks
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).
Measured: Screening (week -2), baseline (week 0); rescored at 12, 24, 36 and 40 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2018
- Study start1 Jan 2019
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mild Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Max Biocare Pty. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Krzysztof Wilczek, MD, Principal investigator, Coramed, Wroklaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03636035
- Sponsor's protocol ID
- MBTR01
- Status last verified
- Feb 2020
- First submitted
- 8 Aug 2018
- Last updated
- 21 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34725289
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Performance of Participants With Mild Knee Osteoarthritis Taking Tregocel® as a Dietary Supplement Alongside Standard of Care Treatment
- ClinicalTrials.gov ID
- NCT03636035
- Acronym / sponsor ID
- MBTR01
- Conditions
- Mild Knee Osteoarthritis
- Keywords
- dietary supplement, arthritis, joint, complementary medicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Max Biocare Pty. Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 17 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tregocel® supplementation | Experimental | Dietary Supplement: Tregocel®Tregocel® coated tablets (2/day) orally for 36 weeks |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tregocel®Coated tablet (oral) | Dietary supplement | Tregocel® supplementation |
Primary outcome
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)
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.
33 secondary outcomes
Physical exam parameter 1: BODY WEIGHT measurement
Time frame: Screening (week -2), baseline (week 0); rescored at 12, 24, 36 and 40 weeks
Physical exam parameter 2: SUBJECT HEIGHT measurement
Time frame: Screening (week -2), baseline (week 0); rescored at 12, 24, 36 and 40 weeks
Vital sign 1: BODY TEMPERATURE
Time frame: Screening (week -2), baseline (week 0); rescored at 12, 24, 36 and 40 weeks
Vital sign 2: BLOOD PRESSURE
Time frame: Screening (week -2), baseline (week 0); rescored at 12, 24, 36 and 40 weeks
Vital sign 3: PULSE RATE
Time frame: Screening (week -2), baseline (week 0); rescored at 12, 24, 36 and 40 weeks
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)
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Safety assessment 2: URINALYSIS (e) pH
Time frame: Performed at screening (week -2), baseline (Week 0); rescored at 12, 24, 36 and 40 weeks
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
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
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
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
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
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
Determination of total usage of PRESCRIPTION ANALGESICS
Time frame: Screening (week -2), baseline (week 0); rescored at 12, 24, 36 and 40 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2022.
- Derived from this study: PubMed 34725289Zegota 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Krzysztof Wilczek, MD principal investigator
Coramed, Wroklaw
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tregocel® in people with Mild Knee Osteoarthritis, run by Max Biocare Pty. Ltd. at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03636035, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2022.