Effectiveness and Safety of Sphaeralcea Angustifolia Standardized Extract as a Topical Treatment of Knee Osteoarthritis

Summary

Knee Osteoarthritis is one of the most frequent rheumatic disorders in the population and, in many cases, it causes disability due to pain, stiffness and deformation. The drugs available for treatment cause adverse events that are sometimes very severe and, for this reason, the development of new drugs for topical administration with fewer adverse events is desirable. OBJECTIVE: To elaborate a phytopharmaceuticals for topical administration with a standardized extract of Sphaeralcea angustifolia and evaluate its efficacy and therapeutic tolerability when administered in patients diagnosed with knee osteoarthritis. MATERIAL AND METHODS: An extract will be obtained from the aerial parts of the plant species S. angustifolia with which a phytomedicine will be designed in a pharmaceutical presentation for topical administration. Once the phytomedicine has been designed, it will be scaled at the pilot plant level and the drug produced will be subjected to a clinical study in order to evaluate its efficacy and therapeutic tolerability in patients diagnosed with knee osteoarthritis. Through a double-blind, randomized, controlled clinical study with 2% diclofenac, patients will be treated topically for four weeks. The evolution of the disease will be evaluated weekly during the four weeks of treatment through the Visual Analogue Scale (VAS) Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) of function. The primary outcome variable will be: therapeutic efficacy (clinical parameters for the evolution of knee pain). The secondary outcome variables will be therapeutic tolerability (side effects that are triggered by the application of the drug), and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) of function. A scale used to evaluate function of the knee

Timeline

Start

2020-07-10

Primary completion

2021-01-16

Completion

2021-06-16

Publications

• Background Perez-Hernandez J, Nicasio-Torres MDP, Sarmiento-Lopez LG, Rodriguez-Monroy M. Production of anti-inflammatory compounds in Sphaeralcea angustifolia cell suspension cultivated in stirred tank bioreactor. Eng Life Sci. 2019 Jan 2;19(3):196-205. doi: 10.1002/elsc.201800134. eCollection 2019 Mar.
• Background Perez-Hernandez J, Gonzalez-Cortazar M, Marquina S, Herrera-Ruiz M, Meckes-Fischer M, Tortoriello J, Cruz-Sosa F, Nicasio-Torres Mdel P. Sphaeralcic acid and tomentin, anti-inflammatory compounds produced in cell suspension cultures of Sphaeralcea angustifolia. Planta Med. 2014 Feb;80(2-3):209-14. doi: 10.1055/s-0033-1360302. Epub 2014 Jan 31.
• Background Romero-Cerecero O, Meckes-Fischer M, Zamilpa A, Enrique Jimenez-Ferrer J, Nicasio-Torres P, Perez-Garcia D, Tortoriello J. Clinical trial for evaluating the effectiveness and tolerability of topical Sphaeralcea angustifolia treatment in hand osteoarthritis. J Ethnopharmacol. 2013 May 20;147(2):467-73. doi: 10.1016/j.jep.2013.03.040. Epub 2013 Mar 23.
• Background Serrano-Roman J, Nicasio-Torres P, Hernandez-Perez E, Jimenez-Ferrer E. Elimination pharmacokinetics of sphaeralcic acid, tomentin and scopoletin mixture from a standardized fraction of Sphaeralcea angustifolia (Cav.) G. Don orally administered. J Pharm Biomed Anal. 2020 May 10;183:113143. doi: 10.1016/j.jpba.2020.113143. Epub 2020 Feb 3.
• Background Meckes M, David-Rivera AD, Nava-Aguilar V, Jimenez A. Activity of some Mexican medicinal plant extracts on carrageenan-induced rat paw edema. Phytomedicine. 2004 Jul;11(5):446-51. doi: 10.1016/j.phymed.2003.06.002.

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