Tregocel® as a Dietary Supplement in Mild Knee Osteoarthritis

M

Max Biocare

Status

Completed

Conditions

Mild Knee Osteoarthritis

Treatments

Dietary Supplement: Tregocel®

Study type

Interventional

Funder types

Industry

Identifiers

NCT03636035
MBTR01

Details and patient eligibility

About

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.

Full 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.

Enrollment

150 patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

150 participants in 1 patient group

Tregocel® supplementation
Experimental group
Description:
Tregocel® coated tablets (2/day) orally for 36 weeks
Treatment:
Dietary Supplement: Tregocel®

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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