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Planta Med 2003; 69(5): 390-395
DOI: 10.1055/s-2003-39710
Original Paper
Clinical Study
© Georg Thieme Verlag Stuttgart · New York

Effectiveness and Tolerability of a Standardized Phytodrug Derived from Solanum chrysotrichum on Tinea pedis: A Controlled and Randomized Clinical Trial

Armando Herrera-Arellano1 , Artemio Rodríguez-Soberanes2 , Maria de los Angeles Martínez-Rivera3 , Eugenia Martínez-Cruz3 , Alejandro Zamilpa1 , Laura Alvarez4 , Jaime Tortoriello1
  • 1Centro de Investigación Biomédica del Sur, Instituto Mexicano del Seguro Social, Morelos, México
  • 2Hospital General Regional No. 1, Instituto Mexicano del Seguro Social, Morelos, México
  • 3Escuela Nacional de Ciencias Biológicas, Instituto Politécnico Nacional, Cd. de México, México
  • 4Centro de Investigaciones Químicas, Universidad Autónoma del Estado de Morelos, Morelos, México
Further Information

Publication History

Received: September 18, 2002

Accepted: January 25, 2003

Publication Date:
12 June 2003 (online)

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Abstract

Superficial mycosis such as Tinea pedis affects between 10 and 15 % of the population and is amongst the top ten reasons for visiting the doctor in Mexico. The vegetal species Solanum chrysotrichum has been, for many years, widely used in Mexican traditional medicine for the treatment of fungal foot infections. This paper illustrates the results of a controlled and randomized, double-blind clinical trial, which compared the therapeutic effect and the tolerability of a standardized phytodrug from S. chrysotrichum (experimental group) with 2 % ketoconazole (control group), applied externally (4 weeks) to 101 patients diagnosed with Tinea pedis. After the treatment, the results showed a clinical effectiveness (≥ 75 % improvement of signs and symptoms) of 96.08 % for the group treated with the S. chrysotrichum extract and 91.67 % for the ketoconazole group (χ2, p > 0.38); the mycologic effectiveness (direct examination and negative culture) was 78.43 % and 77.78 %, respectively (χ2, p > 0.94); whilst the tolerability was 100 % for both treatments. The therapeutic successes (clinical and mycologic effectiveness plus tolerability) was 74.51 % with the experimental treatment and 69.44 % with the control (χ2, p > 0.60). These results support the safety and effectiveness of Solanum chrysotrichum standardized phytodrug for the treatment of Tinea pedis.

Key words

Solanum chrysotrichum - Solaneaceae - Tinea pedis - ketoconazole - controlled double-blind randomised clinical trial - phytopharmaceuticals - complementary and alternative medicine

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Dr. A. Herrera-Arellano

Centro de Investigación Biomédica del Sur

Instituto Mexicano del Seguro Social

Argentina 1

Xochitepec

Mor

México 62 790

Phone: +777 3612155, 3612194

Fax: 3612194

Email: armandoha_mx@yahoo.com.mx