Tregocel® as a Dietary Supplement in Mild Knee Osteoarthritis

Max Biocare Pty. Ltd.150 enrolled

Overview

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.

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

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

150

Conditions

Mild Knee Osteoarthritis

Interventions

Tregocel®DIETARY_SUPPLEMENT

Coated tablet (oral)

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

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

Locations (1)

Clinmed Pharma

Warsaw, Poland

Outcomes

Primary Outcomes

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.

Time frame: Tested at Baseline (week 0) and at end of supplementation (week 36)

Secondary Outcomes

Physical exam parameter 1: BODY WEIGHT measurement

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

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 \[weight (kilogram) / height (metre) \^2\]

Time frame: 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)

Time frame: 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).

Time frame: Screening (week -2), baseline (week 0); rescored at 12, 24, 36 and 40 weeks

Vital sign 3: PULSE RATE

Data from ClinicalTrials.gov

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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

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)

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

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

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).

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.

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

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.

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

Number erythrocytes leukocytes and platelets initially and changes thereafter determined using an automated blood sample analyser (number x 10\^9/litre)