Tregocel® as a Dietary Supplement in Mild Knee Osteoarthritis

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)

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150 participants in 1 patient group

Tregocel® supplementation

Experimental group

Description:

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

Treatment:

Dietary Supplement: Tregocel®