Clinical trial NCT03636035: 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
Overall status: COMPLETED
Phase: NA
Conditions: Mild Knee Osteoarthritis
Keywords: dietary supplement
arthritis
joint
complementary medicine
Lead sponsor: Max Biocare Pty. Ltd.
Sponsor class: INDUSTRY
First posted: 2018-08-17
Enrollment: 150
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Change in distance walked in 6-minutes as an indicator of AMBULATORY MOBILITY
timeFrame: Tested at Baseline (week 0) and at end of supplementation (week 36)
Secondary outcomes:
measure: Physical exam parameter 1: BODY WEIGHT measurement
timeFrame: Screening (week -2), baseline (week 0); rescored at 12, 24, 36 and 40 weeks
measure: Physical exam parameter 2: SUBJECT HEIGHT measurement
timeFrame: Screening (week -2), baseline (week 0); rescored at 12, 24, 36 and 40 weeks
measure: Vital sign 1: BODY TEMPERATURE
timeFrame: Screening (week -2), baseline (week 0); rescored at 12, 24, 36 and 40 weeks
measure: Vital sign 2: BLOOD PRESSURE
timeFrame: Screening (week -2), baseline (week 0); rescored at 12, 24, 36 and 40 weeks
measure: Vital sign 3: PULSE RATE
timeFrame: Screening (week -2), baseline (week 0); rescored at 12, 24, 36 and 40 weeks
measure: Arthritis self-assessment 1: Initial degree of PERCEIVED PAIN represented by manual marking on a simplified printed 100mm linear scale (during Run-in)
timeFrame: Run-in period (week -1 to week 0)
measure: 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
timeFrame: Scores taken at baseline (week 0); rescored at 12, 24, 36 and 40 weeks
measure: 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.
timeFrame: Scores taken at baseline (0 week); rescored at 12, 24, 36 and 40 weeks
measure: 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.
timeFrame: Scores taken at baseline (week 0); rescored at 12, 24, 36 and 40 weeks
measure: Change in target KNEE FLEXIBILITY assessment, based on heel-thigh distance and knee angle at maximal flexion.
timeFrame: Scores taken supine and prone for both knees at baseline (week 0); rescored at 12, 24, 36 weeks
measure: Safety assessment 1: clinical HEMATOLOGY parameters (a) Blood cell count
timeFrame: Performed at screening (week -2), baseline (week 0); rescored at 12, 24, 36 and 40 weeks
measure: Safety assessment 1: clinical HEMATOLOGY parameters (b) hemoglobin level
timeFrame: Performed at screening (week -2), baseline (week 0); rescored at 12, 24, 36 and 40 weeks
measure: Safety assessment 1: clinical HEMATOLOGY parameters (c) sodium level
timeFrame: Performed at screening (week -2), baseline (week 0); rescored at 12, 24, 36 and 40 weeks
measure: Safety assessment 1: clinical HEMATOLOGY parameters (d) potassium level
timeFrame: Performed at screening (week -2), baseline (week 0); rescored at 12, 24, 36 and 40 weeks
measure: Safety assessment 1: clinical HEMATOLOGY parameters (e) aspartate alanine transferase level
timeFrame: Performed at screening (week -2), baseline (week 0); rescored at 12, 24, 36 and 40 weeks
measure: Safety assessment 1: clinical HEMATOLOGY parameters (f) alanine aminotransferase
timeFrame: Performed at screening (week -2), baseline (week 0); rescored at 12, 24, 36 and 40 weeks
measure: Safety assessment 1: clinical HEMATOLOGY parameters (g) total bilirubin level
timeFrame: Performed at screening (week -2), baseline (week 0); rescored at 12, 24, 36 and 40 weeks
measure: Safety assessment 1: clinical HEMATOLOGY parameters (h) alkaline phosphatase level
timeFrame: Performed at screening (week -2), baseline (week 0); rescored at 12, 24, 36 and 40 weeks
measure: Safety assessment 1: clinical HEMATOLOGY parameters (i) creatine level
timeFrame: Performed at screening (week -2), baseline (week 0); rescored at 12, 24, 36 and 40 weeks
measure: Safety assessment 1: clinical HEMATOLOGY parameters (j) blood sodium
timeFrame: Performed at screening (week -2), baseline (week 0); rescored at 12, 24, 36 and 40 weeks
measure: Safety assessment 1: clinical HEMATOLOGY parameters (k) blood potassium
timeFrame: Performed at screening (week -2), baseline (week 0); rescored at 12, 24, 36 and 40 weeks
measure: Safety assessment 2: URINALYSIS (a) presence of leukocytes
timeFrame: Performed at screening (week -2), baseline (Week 0); rescored at 12, 24, 36 and 40 weeks
measure: Safety assessment 2: URINALYSIS (b) presence of nitrites
timeFrame: Performed at screening (week -2), baseline (Week 0); rescored at 12, 24, 36 and 40 weeks
measure: Safety assessment 2: URINALYSIS (c) level of urobilinogen
timeFrame: Performed at screening (week -2), baseline (Week 0); rescored at 12, 24, 36 and 40 weeks
measure: Safety assessment 2: URINALYSIS (d) presence of protein
timeFrame: Performed at screening (week -2), baseline (Week 0); rescored at 12, 24, 36 and 40 weeks
measure: Safety assessment 2: URINALYSIS (e) pH
timeFrame: Performed at screening (week -2), baseline (Week 0); rescored at 12, 24, 36 and 40 weeks
measure: Safety assessment 2: URINALYSIS (f) presence of blood
timeFrame: Performed at screening (week -2), baseline (Week 0); rescored at 12, 24, 36 and 40 weeks
measure: Safety assessment 2: URINALYSIS (g) specific gravity (SG)
timeFrame: Performed at screening (week -2), baseline (Week 0); rescored at 12, 24, 36 and 40 weeks
measure: Safety assessment 2: URINALYSIS (h) ketone level
timeFrame: Performed at screening (week -2), baseline (Week 0); rescored at 12, 24, 36 and 40 weeks
measure: Safety assessment 2: URINALYSIS (i) presence of bilirubin
timeFrame: Performed at screening (week -2), baseline (Week 0); rescored at 12, 24, 36 and 40 weeks
measure: Safety assessment 2: URINALYSIS (j) glucose level
timeFrame: Performed at screening (week -2), baseline (Week 0); rescored at 12, 24, 36 and 40 weeks
measure: Safety assessment 2: URINALYSIS (k) presence of human chorionic gonadotrophin (hCG)
timeFrame: Performed at screening (week -2), baseline (Week 0); rescored at 12, 24, 36 and 40 weeks
measure: Determination of total usage of PRESCRIPTION ANALGESICS
timeFrame: Screening (week -2), baseline (week 0); rescored at 12, 24, 36 and 40 weeks
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Clinmed Pharma
Study officials:
affiliation: Coramed, Wroklaw
name: Krzysztof Wilczek, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.