NCT03636035

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 8, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 17, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

September 21, 2022

Status Verified

February 1, 2020

Enrollment Period

1.5 years

First QC Date

August 8, 2018

Last Update Submit

September 17, 2022

Conditions

Mild Knee Osteoarthritis

Keywords

dietary supplementarthritisjointcomplementary medicine

Outcome Measures

Primary Outcomes (1)

  • 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.

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

Secondary Outcomes (33)

  • Physical exam parameter 1: BODY WEIGHT measurement

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

  • Physical exam parameter 2: SUBJECT HEIGHT measurement

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

  • Vital sign 1: BODY TEMPERATURE

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

  • Vital sign 2: BLOOD PRESSURE

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

  • Vital sign 3: PULSE RATE

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

  • +28 more secondary outcomes

Study Arms (1)

Tregocel® supplementation

EXPERIMENTAL

Tregocel® coated tablets (2/day) orally for 36 weeks

Dietary Supplement: Tregocel®

Interventions

Tregocel®DIETARY_SUPPLEMENT

Coated tablet (oral)

Tregocel® supplementation

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinmed Pharma

Warsaw, Poland

Location

Related Publications (1)

  • 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.

    PMID: 34725289DERIVED

MeSH Terms

Conditions

Arthritis

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Study Officials

  • Krzysztof Wilczek, MD

    Coramed, Wroklaw

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 8, 2018

First Posted

August 17, 2018

Study Start

January 1, 2019

Primary Completion

June 30, 2020

Study Completion

June 30, 2020

Last Updated

September 21, 2022

Record last verified: 2020-02

Locations

PL(1)