Effectiveness of an encecalin standardized extract of Ageratina pichinchensis on the treatment of onychomycosis in patients with diabetes mellitus.

Ageratina pichinchensis is utilized in traditional medicine for the treatment of dermatomycosis and inflammation. The aim of this study was to evaluate the clinical and mycological effectiveness of the topical administration of an enecalin standardized extract of A. pichinchensis for treating onychomycosis in patients with type 2 diabetes mellitus (DM2). A double blind, randomized, and controlled clinical trial was carried out that included patients with DM2 and who had mild or moderate onychomycosis. Participants were administered topically, for 6 months, a lacquer containing the encecalin standardized extract of A. pichinchensis (experimental group) or 8% ciclopirox (control group). In a large percentage of both, the control group (77.2%) and the experimental group (78.5%), clinical efficacy was detected as a decrease in the number of affected nails and a reduction in the severity of nail involvement. Without exhibiting statistically significant differences between groups, the encecalin standardized extract of A. pichinchensis was clinically and mycologically effective in the treatment of mild and moderate onychomycosis in patients with DM2. The treatment of onychomycosis in patients with DM2 implies a greater challenge, while control of blood glucose levels in these patients, played a very important role in the response of patients to treatment.

Antidepressant-Like Effect of Bauhinia blakeana Dunn in a Neuroinflammation Model in Mice.

OBJECTIVE: To evaluate the antidepressant effect of Bauhinia blakeana and a standardized fraction in the forced swimming test (FST) on mice with neuroinflammation induced with lipopolysaccharides (LPS). MATERIALS AND METHODS: Evaluation of the antidepressant effect of Bauhinia blakeana hydroalcoholic extract (BbHA) and its fractions was carried out in behavioral tests on mice with LPS-induced neuroinflammation. RESULTS: BbHA had a significant antidepressant effect, measured on healthy mice in the FST. Bio-guided chemical separation of the extract produced a methanolic fraction (BbMe), which decreased the immobility time in FST. In this test, the intraperitoneal administration of LPS induced depression in mice, and BbHA and BbMe counteracted this effect, significantly decreasing the induced depression. Quantification of inflammatory mediators (IL-10, IL-4, IL-6, IL-1ß, and TNF-α) in the brain demonstrated that BbHA and BbMe effectively decreased the effect of LPS on the brain concentration of all measured cytokines. CONCLUSIONS: Bauhinia blakeana produced an antidepressant effect, while BbMe also exerted a modulating effect, on the damage induced by LPS. Rutin, a glycosylated flavonoid, was identified as the main compound in the active fraction, which could mediate in the antidepressant and immunomodulatory effect.

Effectiveness of Ageratina pichinchensis Extract in Patients with Vulvovaginal Candidiasis. A Randomized, Double-Blind, and Controlled Pilot Study.

Previous clinical studies have demonstrated the antifungal effectiveness of Ageratina pichinchensis extracts when topically administered to patients with dermatomycosis. The objective of this study was to evaluate the effectiveness and tolerability of a 7% standardized extract of A. pichinchensis (intravaginal) in patients with vulvovaginal candidiasis. The extract was standardized in terms of its encecalin content and administered during 6 days to patients with Candida albicans-associated vulvovaginitis. The positive control group was treated with Clotrimazole (100 mg). On day 7 of the study, a partial evaluation was carried out; it demonstrated that 94.1% of patients treated with Clotrimazole and 100% of those treated with the A. pichinchensis extract referred a decrease or absence of signs and symptoms consistent with vulvovaginal candidiasis. In the final evaluation, 2 weeks after concluding administration, 86.6% of patients in the control group and 81.2% (p = 0.65) of those treated with the A. pichinchensis extract demonstrated therapeutic success. Statistical analysis evidenced no significant differences between the two treatment groups. With the results obtained, it is possible to conclude that the standardized extract from A. pichinchensis, intravaginally administered, showed therapeutic and mycological effectiveness, as well as tolerability, in patients with vulvovaginal candidiasis, without noting statistical differences in patients treated with Clotrimazole. Copyright © 2017 John Wiley & Sons, Ltd.

Effectiveness and tolerability of a standardized extract from Ageratina pichinchensis in patients with diabetic foot ulcer: a randomized, controlled pilot study.

Previous works have shown that extracts obtained from Ageratina pichinchensis are capable of reducing the time needed for wounds to heal. By means of a randomized, double-blind pilot study, the objective of this work was to evaluate the effectiveness and tolerability of a phytopharmaceutical developed with a standardized extract (5 %, cream formulation) of A. pichinchensis, topically administered in patients with diabetic foot ulcer. Micronized silver sulfadiazine (1 %) was employed as a control treatment. Treatments were randomly assigned to each patient, and clinical evolution was evaluated weekly until complete healing of the wound. All patients who concluded the study achieved complete healing of their ulcers. After six weeks of treatment, patients in the experimental group exhibited a wound-healing process of 77.5 %, while that of patients in the control group was 69.8 %. A statistically significant difference was not found between groups. The average time needed for complete wound healing was 65.47 ± 47.08 days for patients treated with the A. pichinchensis extract and 77.46 ± 50.8 days for patients in the control group (p = 0.509). There was no case in either of the groups in which adverse side effects were identified. Thus, it was concluded that the A. pichinchensis extract showed the ability to improve the healing process in patients with diabetic foot ulcer; however, no statistically significant differences were observed when compared with results obtained in patients administered the control treatment (micronized silver sulfadiazine). Some limitations of this study must be addressed, such as small sample size. This work comprises a pilot study that could be useful in a future clinical trial with a greater number of patients.

Pharmacological and chemical study to identify wound-healing active compounds in Ageratina pichinchensis.

The aerial parts of Ageratina pichinchensis are used in Mexican traditional medicine for the treatment of skin wounds. Recently, it was demonstrated that the aqueous extract of this plant reduced the time required to cicatrize a wound induced in the rat. The same extract showed a capability to induce overgrowth in normal fetal lung cells (MRC-5). The objective of the present study was isolating and identifying the active compounds in A. pichinchensis that are capable of inducing cellular overgrowth, as well as performing a preliminary evaluation of their anti-inflammatory and toxic effects. By means of bioguided chemical separation of an aqueous extract of A. pichinchensis, the most active compound capable of inducing cellular overgrowth was identified as 7-O-(ß-D-glucopyranosyl)-galactin. In vivo inflammation induced with carrageenan in mice was significantly reduced by the aqueous extract of A. pichinchensis, reaching a decrease of up to 60.6 %. Acute (2 g/kg) and subchronic (1 g/kg for 28 days) oral administration of the aqueous extract of this plant did not affect hepatic function (through alanine aminotransferase and aspartate aminotransferase activity evaluation), while no alterations of the histologic samples of liver and kidney were evidenced.

Pharmacological and Chemical Analysis of Bauhinia divaricata L. Using an In Vitro Antiadipogenic Model.

Obesity is characterized by an excessive and abnormal accumulation of fat. According to the 2022 National Health and Nutrition Survey, in Mexico, the prevalence of overweight and obesity-diagnosed if one's body mass index (BMI) was ≥25 kg/m2-in adults was 75.2%. A strong association between the amount of visceral fat and diseases such as diabetes mellitus type II has been recognized. Species of the Bauhinia genus have lipid-lowering and antidiabetic properties. The aim of this work was to evaluate the lipolytic and antiadipogenic activity of Bauhinia divaricata L. in 3T3-L1 cells and to identify the major compounds in the bioactive treatments. The extraction of aerial parts allowed us to obtain hexanic (BdHex), ethyl acetate (BdEAc), and hydroalcoholic (BdHA) extracts. Lipid levels were measured in 3T3-L1 cells differentiated into adipocytes. Our evaluation of cell viability identified an IC50 > 1000 µg/mL in all the extracts, and our evaluation of the antiadipogenic activity indicated that there was a significant reduction (p < 0.001) in the accumulation of lipids with hydroalcoholic (60%) and ethyl acetate (75%) extracts of B. divaricate compared with metformin at 30 mM (65%). The major compounds identified in these extracts were as follows: triacetin (1), 2,3-dihydroxypropyl acetate (2), (3E)-2-methyl-4-(1,3,3-trimethyl-7-oxabicyclo[4.1.0]hept-2-yl)-3-buten-2-ol (3), 2,5-dihydroxyphenylacetic acid (4), (3R)-3-hydroxydodecanoic acid (5), kaempferol-3-O-rhamnoside (6), and quercetin 3-O-rhamnoside (7). Some of these naturally occurring compounds have been related to the anti-obesity effects of other medicinal plants; therefore, these compounds isolated from B. divaricata could be responsible for inhibiting the differentiation process from preadipocytes to mature adipocytes.

Exploratory study on the effectiveness of a standardized extract from Ageratina pichinchensis in patients with chronic venous leg ulcers.

The aerial parts of the species Ageratina pichinchensis, popularly known as "axihuitl", have been empirically used in Mexico for wound-healing purposes. The evaluation of an extract from A. pichinchensis (in an in vivo model) demonstrated its capacity to reduce, in a significant manner, the time required for wound healing in rodent skin. This same extract showed (in vitro) a capacity of encouraging proliferation of normal human fetal lung fibroblasts (MRC-5). This study's objective was to evaluate, in a clinical trial, the effectiveness and tolerability of the topical administration of a product elaborated with the standardized extract from the aerial parts of A. pichinchensis in patients with chronic venous leg ulcers, and to compare the effect with a control group treated with 7 % propylene glycol alginate. In this study, a total of 34 patients were included (50 % in each group). Six patients of the control group withdrew from the treatment, three of these because of lack of recovery. In the experimental group, 2 participants withdrew from the study, but none of these due to treatment or clinical-evolution reasons. The A. pichinchensis extract showed therapeutic effectiveness in one hundred percent of the patients treated with it, while the control treatment achieved this condition in 81.8 % of the control group patients. Ulcer size reduction resulted significantly higher (p < 0.010) in the group of patients administered the experimental treatment, which allows us to assure that the A. pichinchensis standardized extract is effective in the treatment of chronic venous leg ulcers and, compared with the 7 % propylene glycol alginate formula, achieves a significant reduction of the time required for the ulcers to heal.

Effect on the wound healing process and in vitro cell proliferation by the medicinal Mexican plant Ageratina pichinchensis.

The species Ageratina pichinchensis (Asteraceae) has been used for a long time in Mexican traditional medicine for the treatment of different skin conditions and injuries. In this study, the healing capacity of the plant extracts obtained was evaluated and, in order to understand the mechanism of healing, we also analyzed its effect on cell proliferation IN VITRO, cytotoxicity, and skin irritation. Different extracts obtained from the aerial parts of A. pichinchensis, topically administrated, were evaluated in a healing model by scalpel-blade incision on the rat. The extracts, at 10 % concentrations, were administrated daily during an eight-day period. A control group, to which the vehicle was administered, was used; while fibrinolysin (Fibrase SA®) was administered for positive control purposes. Reduction in wound size and the histological characteristics of the skin at the end of the treatment were evaluated. Cytotoxicity was evaluated in cell lines KB (nasopharyngeal carcinoma), UISO (squamous cell carcinoma of the cervix), OVCAR (ovarian carcinoma), and HCT-15 (colon carcinoma). In addition, the effect on cell proliferation of cell line MRC-5 (normal cells from human fetal lung) was measured, and skin irritation was evaluated. The results showed an important healing capacity of A. pichinchensis extract in noninfected wounds; the aqueous extract was found to be the most efficient. The extracts exhibited no cytotoxic effect; however, there was an effect that promoted cell proliferation in cell line MRC-5. The products tested demonstrated no skin irritant effects.

[Use of medicinal plants in patients with symptoms of generalized anxiety]. / Uso de plantas medicinales en pacientes con síntomas de ansiedad generalizada.

BACKGROUND: Anxiety is one of the most common mental disorders. It has an impact on the decrease of productivity, the affectation of quality of life, and the increase in health care costs. The study of plant species with medicinal properties to treat anxiety has made significant progress, since they have been evaluated through in vitro, in vivo and clinical studies. OBJECTIVE: To identify the use of medicinal plants among patients with symptoms of generalized anxiety disorder (GAD). MATERIAL AND METHODS: A diagnostic questionnaire, including the Hamilton Anxiety Rating Scale, and another related with the use of medicinal plants, was applied. It was designed specifically for this study, and it was used in subjects and/or their companions, who visited an Instituto Mexicano del Seguro Social hospital. RESULTS: The study had 985 subjects, 802 women, with a median age of 37.1 ± 15.17; anxiety symptoms were identified in 95.9% (940); according to the number of signs and symptoms, 53.1% (523) of subjects may have suffered a moderate or severe degree of anxiety. 23.09% (187) used medicinal plants to treat their symptoms. 39 plant species were identified as used by patients with GAD symptoms. Of these, 76.3% (29) had a history of ethnomedical use on mental disorders. CONCLUSIONS: A high percentage of the population in Mexico presents symptoms of GAD. A significant number of patients use medicinal plants to treat the symptoms of anxiety, even when they do not know that their symptomatology is part of a mental disorder.

INTRODUCCIÓN: la ansiedad es uno de los trastornos mentales más comunes. Incide en la pérdida de productividad, la afectación de la calidad de vida y el aumento en el gasto de la atención médica. El estudio de especies vegetales con propiedades medicinales para tratar la ansiedad ha progresado, al evaluarse con estudios in vitro, in vivo y clínicos. OBJETIVO: identificar el uso de plantas medicinales en pacientes con síntomas de trastorno de ansiedad generalizada (TAG). MATERIAL Y MÉTODOS: se aplicó un cuestionario diagnóstico que incluía la Escala para ansiedad generalizada de Hamilton y otro relacionado con el uso de plantas medicinales. Se diseñó ex profeso para personas que acuden a consulta a un hospital del IMSS o sus acompañantes (si eran derechohabientes). RESULTADOS: participaron 985 personas, 802 mujeres, con una mediana de edad de 37.1 ± 15.17; en 95.9% (940) se identificaron síntomas de ansiedad; el 53.1% (523) de los encuestados pudo haber estado padeciendo un grado de ansiedad moderada o severa. Del total, 23.09% (187) usaban plantas medicinales para tratar sus síntomas. Se identificaron 39 especies vegetales que empleaban los pacientes con síntomas de TAG. De ellas, 76.3% (29) tenía antecedentes de uso etnomédico en trastornos mentales. CONCLUSIONES: un alto porcentaje de la población en México presenta síntomas de TAG. Un número importante de los pacientes usa plantas medicinales para tratar los síntomas de ansiedad, aun cuando no saben que su sintomatología es parte de un desorden mental.

Galphimine-B Standardized Extract versus Alprazolam in Patients with Generalized Anxiety Disorder: A Ten-Week, Double-Blind, Randomized Clinical Trial.

Galphimine-B (G-B), a compound isolated from Galphimia glauca, has been shown to possess important anxiolytic activity. In this study, we evaluated the effectiveness and tolerability of a G-B standardized extract (experimental treatment) that was administered daily for 10 weeks in patients with moderate or severe Generalized Anxiety Disorder (GAD). Alprazolam was used as control treatment and administered under the same conditions. A total of 167 patients were included. At the start of the study, the severe anxiety condition prevailed, with an average on the Hamilton Anxiety Scale of 35.1 ± 8.8 and 35.8 ± 8.1 points in the control and experimental groups, respectively. After the 10 weeks of administration, the average was reduced in the control group to 4.6 ± 6.5 points and in the experimental group to 3.5 ± 5.5 points. Therapeutic success in the control group was 85.7% and in the experimental group, 92.0%. A high proportion of patients (22.2%) treated with Alprazolam manifested daytime sleepiness, while in the group treated with the G-B standardized extract, daytime sleepiness was found in 4.7%. In conclusion, a G-B standardized extract demonstrated therapeutic effectiveness in patients with GAD, without exhibiting significant difference with Alprazolam, but showing fewer cases of daytime sleepiness. The trial was registered at http://clinicaltrials.gov by identifier: NCT03702803.

Therapeutic Effectiveness of Galphimia glauca in Young People with Social Anxiety Disorder: A Pilot Study.

Social anxiety is one of the most common disorders found in the population attending the first level of health care. Galphimia glauca has been used for many years in Mexican traditional medicine to treat "nervous disorders". A standardized extract of this species has been evaluated in clinical studies that have proven its efficacy and safety in patients with generalized anxiety disorder. In this work, a double-blind clinical trial was carried out, using sertraline as a control. Patients from both sexes (18 to 35 years old) with moderate or severe social anxiety were included. Experimental group was treated daily (orally), for 10 weeks, with an extract from G. glauca containing 0.374 mg/dose of Galphimine-B (G-B, active compound). Patients in the control group were given sertraline (50 mg) in the same conditions. All patients were evaluated every two weeks. Another assessment was done one month after the end of the administration period. A total of 34 patients was included, 17 in each group. Women were predominant, and the mean age was 25 ± 4.7 years. In patients who received the G. glauca standardized extract, a significant reduction in anxiety was observed, with a value (in the Brief Social Phobia Scale) of 41.1±10.3 points at the start and 11.2±5.6 points at the end of treatment, while patients treated with sertraline had a value of 37.7±7.3 points at the beginning and 11.1±5.2 points at the end. No significant difference was observed between the treated groups. In a similar way, the health scale showed a gradual and continuous improvement in each of the five evaluations. In conclusion, the 10-week oral administration of G. glauca standardized extract showed efficacy and safety in patients with social anxiety disorder, without showing a significant difference from patients treated with sertraline.

[Knowledge about phytopharmaceuticals among physicians affiliated to secondary care hospitals]. / Conocimiento sobre fitomedicamentos entre médicos del segundo nivel de atención.

OBJECTIVE: to analyze the knowledge about phytopharmaceuticals of specialists affiliated to secondary care hospitals in the State of Morelos, Mexico. MATERIAL AND METHODS: the study was conducted through a survey in which 278 medical doctors participated. They were randomly selected from Instituto Mexicano del Seguro Social (IMSS), Sistema de Salud de Morelos (SSM) and private practice facilities. Their knowledge was rated as: "low," "medium," and "advanced." To determine the frequency and distribution of the variables, univariate analysis was done and to ascertain the associations between variables, the chi(2) test was used. RESULTS: 79.1% of physicians had low level of knowledge; 11.1% had medium level and 9.1% had advanced knowledge; the variable "working in the morning shift" was associated with advanced knowledge (p = 0.036). CONCLUSIONS: The low level of knowledge about phytopharmaceuticals should prompt to include this topic within the academic programs of health workers and the continuous medical education activities for practicing physicians.

[Knowledge of phytopharmaceuticals among physicians from Morelos, Mexico]. / Conocimiento sobre fitofámacos en médicos de atención primaria del estado de Morelos.

OBJECTIVES: To analyze the proportion of primary care physicians from the Health System in the State of Morelos with knowledge about phytopharmaceuticals, and to explore some factors related to this knowledge. MATERIAL AND METHODS: Through a descriptive, transversal and prospective study, physicians who work in the Instituto Mexicano del Seguro Social, in the Secretaría de Salud in the State of Morelos, and in private practice, an "adequate knowledge" was conveyed when 70% or more answers were correct and "deficient knowledge," when this proportion was lower than 70%. A bivariated analysis was used in order to determine association and statistical differences. RESULTS: A total of 264 physicians were included. The majority (90.2%) fell in the group of "deficient knowledge," and only 9.8% fell into the "adequate knowledge" group. An association was found between the possession of adequate knowledge and private physicians (PR = 4.66, CI = 95%), as well as deficient knowledge and working in a morning shift (PR = 2.92, CI = 95%). CONCLUSIONS: As the results demonstrate, knowledge about phytopharmaceuticals among primary care physicians is deficient, regardless of the institution where they work.

Pilot study that evaluated the clinical effectiveness and safety of a phytopharmaceutical elaborated with an extract of Ageratina pichinchensis in patients with minor recurrent aphthous stomatitis.

ETHNOPHARMACOLOGICAL RELEVANCE: The plant species Ageratina pichinchensis (Schauer) R.M.King & H.Rob. (Asteraceae) in a wild plant native to Mexico that is utilized in traditional medicine for the treatment of skin problems and for mouth ulcers. AIM OF THE STUDY: The objective of the present study was to evaluate the clinical effectiveness and therapeutic safety of a phytopharmaceutical elaborated with a unpigmented hexane-ethyl acetate extract of A. pichinchensis at a concentration of 5% in patients with a clinical condition of Minor Recurrent aphthous stomatitis (MiRAS). MATERIALS AND METHODS: We conducted a double-blind, randomized, and controlled pilot study in which the experimental treatment was a phytopharmaceutical elaborated with a unpigmented hexane-ethyl acetate extract of A. pichinchensis at a 5% concentration and, as control treatment, we utilized Triamcinolone at 0.1%. Study participants were patients with a diagnosis of MiRAS, elderly males and females, with a disease evolution of no. >3 days. Lesion size was measured by means of a tracing sheet and pain, by the Visual analog scale (VAS). Output variables comprised clinical effectiveness, treatment adherence, therapeutic failure, and therapeutic success. RESULTS AND DISCUSSION: Fifty six patients participated in the study and we distributed these into two study groups (28 in each group). The results obtained did not show statistically significant differences between the experimental and the control treatments. Among patients treated with the A. pichinchensis extract, the time required for achieving the absence of pain was 4.0 days, while that of the control treatment was 4.1 days. In patients treated with A. pichinchensis, the time necessary for healing was 4.5 days and for the Triamcinolone 0.1%-treated group, this was 4.7 days. Greater clinical effectiveness was evidenced on days 2, 3, and 4 of treatment. During the first 7 follow-up days, there was clinical effectiveness in 92.8% of experimental-group and in 89.2% of control-group patients. At the end of the study, 100% therapeutic effectiveness was able to be scored.

Aislamiento e identificación de compuestos con actividad antiobesidad y antiadipogénica de Thevetia peruviana / Isolation and identification of anti-obesity and anti-adipogenic compounds from Thevetia peruviana

Thevetia peruviana ha sido utilizada en la medicina tradicional mexicana por sus efectos adelgazantes. Para la identificación de las fracciones y los compuestos activos de T. peruviana se utilizó cromatografía en columna abierta y las fracciones obtenidas se evaluaron en ratones con obesidad inducida con glutamato monosódico. Como control positivo se utilizó Orlistat y los tratamientos se administraron oralmente una vez al día durante 8 semanas. La fracción con mayor actividad fue sub-fraccionada y, con la intención de evitar el uso de más ratones, los productos fueron seleccionados por su capacidad para inhibir la adipogénesis en la línea celular 3T3-L1. Los animales tratados con la fracción F-B mostraron un aumento de peso significativamente menor y mantuvieron la sensibilidad a la insulina, así como, niveles significativamente más bajos de colesterol y triglicéridos. El análisis de GC-MS indicó que esta fracción activa está compuesta principalmente por los ácidos palmítico (1), oleico (2) y octadacanoico (3), 2-palmitoil glicerol (4), 2-oleoil glicerol (5) así como la estigmastenona (6).

Thevetia peruviana has been used in Mexican traditional medicine for its slimming effects. Active fractions and compounds from T. peruviana were isolated and identified by means of gravitational open-column chromatography, and the fractions were evaluated on mice with MonoSodium Glutamate-induced obesity. Orlistat was used as positive control, and treatments were administered, orally, once a day for 8 weeks. The fraction with higher activity was sub-fractioned and, with the intention of avoiding using more mice, the fractions were analyzed by evaluating their capability to inhibit adipogenesis in the 3T3-L1 cell line. Animals treated with the F-B fraction revealed a significantly smaller weight increase and maintained adequate insulin sensitivity, and significantly lower blood levels of cholesterol and triglycerides. The active compounds that demonstrated greatest adipogenesis inhibition were palmitic acid (1), oleic acid (2), octadecanoic acid (3), 2-palmitoyl glycerol (4), 2-oleoyl glycerol (5) and stigmastenone (6).

Pharmacological effect of Ageratina pichinchensis on wound healing in diabetic rats and genotoxicity evaluation.

ETHNOPHARMACOLOGICAL RELEVANCE: Among the main causes affecting the wound healing process, we find diabetes mellitus, which is due to the occurrence of a prolonged inflammation phase, defects in angiogenesis, and a diminution in fibroblast proliferation. The species Ageratina pichinchensis has been utilized in Mexican traditional medicine for the treatment of skin wounds. Pharmacological models have demonstrated that an extract obtained from this species improves wound healing and, through a clinical study, it was evidenced that the extract (in a pharmaceutical form) is effective in the treatment of patients with chronic venous ulcers. The 7-O-(ß-D-glucopyranosyl)-galactin compound was recently identified as responsible for the pharmacological activity. The objective of the present study was to evaluate the wound healing activity of an aqueous extract and another hexane-ethyl acetate extract from Ageratina pichinchensis (both standardized in the active compound) in a diabetic foot ulcer rat model, as well as evaluating the possible genotoxic effects produced by the same species. MATERIALS AND METHODS: Rats with streptozotocin-induced diabetes were submitted (under anesthesia with pentobarbital) to a circular lesion on the skin (excisional) on the rear of the paw. All animals were topically treated daily until healing. 5-methyl-1 phenyl-2-(1H) Pyridone was used as a positive control treatment. Once the wound was healed, a skin sample was obtained and utilized for histopathological analysis. The possible genotoxic effects produced by the extract, in a model of spermatozoid viability and morphology, were evaluated. RESULTS: The results showed that 100% of animals treated with Ageratina pichinchensis extracts presented wound healing between days 4 and 11 of treatment, while in the positive control group (treated with 5-methyl-1 phenyl-2-(1H) pyridone) and in the negative control group (vehicle), only 70% and 40%, respectively, exhibited wound healing at day 11. Histological analysis demonstrated evidences of an active regenerative process in animals that received the extracts, in addition to that in the study, the effects of the plant extracts that could be compatible with genotoxicity were not observed. CONCLUSIONS: Aqueous and hexane-ethyl acetate extracts of the aerial parts of Ageratina pichinchensis (standardized in its content of 7-O-(ß-D-glucopyranosyl)-galactin), consistently improve wound healing induced on the skin of rats with streptozotocin-induced diabetes. The capacity was evidenced of the extracts to promote histological tissue regeneration, without exhibiting genotoxicity.

Clinical trial for evaluating the effectiveness and tolerability of topical Sphaeralcea angustifolia treatment in hand osteoarthritis.

ETHNOPHARMACOLOGICAL RELEVANCE: Sphaeralcea angustifolia Cavanilles & Don (Malvaceae), known in Mexico as "Vara de San José", is used in Mexican Traditional Medicine as an anti-inflammatory and, more specifically, for treating rheumatism. Anti-inflammatory properties have been demonstrated in different pharmacological models. AIM OF THE STUDY: The therapeutic effectiveness and tolerability of the topical administration of a gel elaborated with a standardized Sphaeralcea angustifolia extract applied to patients with Hand osteoarthritis (HOA) was evaluated. MATERIALS AND METHODS: A pharmaceutical formulation in a gel presentation that contained a standardized extract (hydroxycoumarin content) of Sphaeralcea angustifolia was elaborated and later evaluated in a double-blind, randomized study controlled with a similar formulation containing 2% diclofenac. Treatments were administered topically for 4 weeks on the affected hand(s). Clinical evolution was followed weekly by means of the Algofunctional Index (AFI) and the Visual Analog Scale (VAS). RESULTS AND DISCUSSION: A total of 130 participants were included in the study. Among these, 113 were considered in the analysis (55 in the experimental group and 58 in the control group). In both groups, important improvement in the patients' symptomatology was noted. Therapeutic effectiveness was 89% and 91.3% in the two groups, respectively, without a statistically significant difference between the groups. None of the treatments presented any adverse effects. CONCLUSION: The 4-week topical administration of a gel formulation elaborated with a 1% standardized extract of Sphaeralcea angustifolia showed therapeutic effectiveness and tolerability when administered to patients with HOA, without exhibiting significant differences when compared with the effect observed in patients treated with 2% diclofenac.

Therapeutic effectiveness of Ageratina pichinchensis on the treatment of chronic interdigital tinea pedis: a randomized, double-blind clinical trial.

OBJECTIVES: Interdigital tinea pedis is the most frequent presentation, as well as the most severe clinical form of tinea pedis, constituting a therapeutic challenge. The aim of the study was to evaluate the effectiveness and tolerability of two concentrations of Ageratina pichinchensis extract (encecalin content, 0.76 and 1.52%, respectively) on patients with clinical and mycological diagnosis of chronic interdigital tinea pedis. DESIGN: By means of a randomized, double-blind clinical trial, three groups of patients were treated topically for 4 weeks with a cream containing the following: Group I-the lower concentration of A. pichinchensis extract, group II-the higher concentration, group III-2% ketoconazole. SUBJECTS: One hundred and sixty (160) ambulatory patients of either sex between the ages of 18 and 65 years were enrolled. OUTCOME MEASURES: The primary outcome variables were: clinical effectiveness, mycological effectiveness, therapeutic cure, tolerability, and treatment compliance. The secondary outcome variable was therapeutic success. RESULTS: At the end of treatment, therapeutic cure was achieved by 34.1, 41.8, and 39.53% of Groups I, II, and III, respectively. No statistical difference between the groups was observed. CONCLUSIONS: Both treatments were effective for the treatment of interdigital-type tinea pedis, while better results were observed on patients that received the higher concentration of the extract.

Clinical trial to compare the effectiveness of two concentrations of the Ageratina pichinchensis extract in the topical treatment of onychomycosis.

UNLABELLED: The plant species Ageratina pichinchensis has been used, for many years, in Mexican traditional medicine for the treatment of superficial mycosis. AIM OF THE STUDY: This study compared the therapeutic effectiveness and tolerability of two concentrations of the standardized extract from Ageratina pichinchensis (12.6 and 16.8%) on patients with clinical and mycological diagnosis of mild and moderate onychomycosis. MATERIALS AND METHODS: Two identical phytopharmaceuticals (containing the standardized extract from Ageratina pichinchensis) in nail lacquer solution for topical administration were evaluated in a double-blind clinical trial. Treatments were administered for 6 months to patients distributed in two groups. RESULTS AND DISCUSSION: Of 122 patients who agreed to participate in the study, 103 (84.4%) concluded the treatment. The therapeutic effectiveness exhibited by the 12.6% Ageratina pichinchensis extract was 67.2%, while that of the 16.8% Ageratina pichinchensis extract was 79.1%. Regarding clinical evolution, analysis of results at the end of treatment evidenced that the 16.8% concentration possesses higher therapeutic effectiveness with a significant statistical difference (p=0.010). No treatment produced side effects. CONCLUSION: Both concentrations of phytopharmaceuticals possess high rates of effectiveness on patients with mild and moderate onychomycosis, and the formulation with a 16.8% concentration possesses higher effectiveness.

Double-blind clinical trial for evaluating the effectiveness and tolerability of Ageratina pichinchensis extract on patients with mild to moderate onychomycosis. A comparative study with ciclopirox.

Aerial parts of AGERATINA PICHINCHENSIS have been used, in Mexican traditional medicine, as a remedy for the treatment of skin mycosis. Onychomycosis, also known as tinea of the nails or tinea unguium, constitutes an infection of the nails produced by dermatophytes. Clinically, onychomycosis is manifested by changes on the color, texture and thickness of the nail. The agent most frequently found in this disease is TRICOPHYTON RUBRUM. The present study evaluated the therapeutic effectiveness and tolerability of topical administration of A. PICHINCHENSIS extract on the nails of patients with the clinical and mycological diagnosis of onychomycosis. A phytopharmaceutical formulation was developed in a lacquer solution containing the standardized (encecalin) extract of A. PICHINCHENSIS. A similar lacquer solution containing 8 % ciclopirox was used as control. Treatments were assigned randomly and administered topically for 6 months. Ninety six patients concluded the study (49 in the experimental group and 47 in the control); 71.1 % of patients from the experimental and 80.9 % from the control group showed therapeutic effectiveness, while 59.1 % and 63.8 % from the experimental and control group, respectively, achieved mycological effectiveness. Therapeutic success was observed in 55.1 and 63.8 %, respectively. No patient exhibited intense side effects. Statistical analysis demonstrated no differences between treatments.