MW Balance AG, CH-8866 Ziegelbrücke, 17.1.2017

Controlled clinical trial (double blind study)

Universidad Autónoma de Nuevo León
Hospital Universitario “Dr. José Eleuterio González”
Departamento de Ortopedia y Traumatología

Controlled clinical trial (double blind study)

 

 

NEW ORAL EVALUATION THERAPY (COLLAGEN HYDROLISATE 10 G, BROWN SEAWEED EXTRACT FUCOIDAN 100 MG) TO DECREASE THE SYMPTOMS OF II – III DEGREE GONARTHROSIS COMPARED WITH INTRAARTICULAR HYALURONIC ACID AND INTRAARTICULAR PLATELET – RICH PLASMA.

 

Researchers:
– Ph.D. Eduardo Álvarez Lozano
– Ph.D. Carlos Alberto Acosta Olivos
– Ph.D. José Félix Vílchez Cavazos
– Ph.D. Mario Simental Mendía
– Yadira Alejandra Tamez Mata
– Alejandro González Parás
– Student Ramón Quintanilla Loredo

 

Methodology:
Controlled clinical trial (double blind study)
Number of patients: 108
Number of groups: 3
Patients per group: 36
*ADA and AHA

 

Inclusion criteria:
– Osteoartrosis diagnose by radiological and clinical criteria
– II – III Kellgren – Lawrence Score
– Both genders
– Between 40 and 90 years old

 

Exclusion criteria:
– Pregnant women
– Breastfeeding women
– Previous knee surgeries
– Arthroscopy with at least 1 year before
– Intraarticular injections (hyaluronic acid and platelet – rich plasma) 9 months before
– Use of glucosamine and chondroitin 6 months before
– Use herbology products
– Comorbidities like: gout, heart failure, diabetes mellitus (HbA1c > 7%) and hypertension (>140/90 mmHg) *

 

Elimination criteria:
– Not coming to check up
– Stop treatment

 

Success criteria:
Decrease of the symptoms and improvement of the functional scales at the end of the treatment. This treatment must be better than the intraarticular therapy.

 

Discussion:
In this CCE we want to probe that the ACTEN therapy is better compared with intraarticular therapy (Hyaluronic Acid and Platelet-Rich Plasma) decreasing the symptoms of the gonarthrosis.

The 108 patients were randomly assigned in 3 groups.
The CCE lasts 3 months and the patients will be scheduled every 2 weeks.
The surveys we will use are: WOMAC, SF-12 and VAS in the baseline, 1 month and 3 months.
A blood sample will be taken to all patients.
All of the patients will receive an intraarticular injection

Group 1 placebo (saline solution)
Group 2 HYALURONIC ACID
Group 3 PLATELET – RICH PLASMA

All of the patients will receive an oral therapy
*All of the oral therapy was changed to a metallic package (25 g).

Group 1: ACTEN
Group 2 and 3: placebo (liquid chlorophyll)