Trial | NCT03636035  Report issue

Title

Tregocel® as a Dietary Supplement in Mild Knee Osteoarthritis
Assessment of Performance of Participants With Mild Knee Osteoarthritis Taking Tregocel® as a Dietary Supplement Alongside Standard of Care Treatment

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    150
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.
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.
Study Started
Jan 01
2019
Primary Completion
Jun 30
2020
Study Completion
Jun 30
2020
Last Update
Sep 21
2022

Dietary Supplement Tregocel®

Coated tablet (oral)

Tregocel® supplementation Experimental

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

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
No Results Posted