Tregocel® as a Dietary Supplement in Mild Knee Osteoarthritis

NCT ID: NCT03636035

Last Updated: 2022-09-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2020-06-30

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.

Detailed 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.

Conditions

Mild Knee Osteoarthritis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Tregocel® supplementation

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

Group Type: EXPERIMENTAL

Tregocel®

Intervention Type: DIETARY_SUPPLEMENT

Coated tablet (oral)

Interventions

Tregocel®

Coated tablet (oral)

Intervention Type: DIETARY_SUPPLEMENT

Eligibility 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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Max Biocare Pty. Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Krzysztof Wilczek, MD

Role: PRINCIPAL_INVESTIGATOR

Coramed, Wroklaw

Locations

Clinmed Pharma

Warsaw, , Poland

Countries

Poland

References

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.

Reference Type: DERIVED

PMID: 34725289 (View on PubMed)

Other Identifiers

MBTR01

Identifier Type: -

Identifier Source: org_study_id