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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

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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