Medical Study 2018

Controlled clinical trial (double blind study) in process NEW ORAL EVALUATION THERAPY (COLLAGEN HYDROLISATE 10 G, BROWN SEAWEED EXTRACT 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:s

– 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)