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.
– 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
Controlled clinical trial (double blind study)
Number of patients: 108
Number of groups: 3
Patients per group: 36
*ADA and AHA
– Osteoartrosis diagnose by radiological and clinical criteria
– II – III Kellgren – Lawrence Score
– Both genders
– Between 40 and 90 years old
– 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) *
– Not coming to check up
– Stop treatment
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.
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)