Fenugreek Leaf Extract and Its Gel Formulation Show Activity Against Malassezia furfur.

Malassezia spp. are commensal yeasts that can cause cutaneous ailments such as dandruff and seborrheic dermatitis. We sought to develop a cost-effective, herbal formulation for the treatment of cutaneous ailments related to Malassezia spp. Aqueous and ethanolic extracts of fenugreek (Trigonellafoenum-graecum L.) leaves exhibited activity against a clinical isolate and commercial strain of Malassezia furfur. The extracts were also found to be active against other pathogenic fungi such as Aspergillus niger and Candida albicans. Qualitative and quantitative phytochemical evaluation of aqueous extract showed a predominant presence of flavonoids apart from alkaloids, saponins, carbohydrates, phenols, and proteins. Gel formulation of 30% aqueous fenugreek leaf extract was developed and optimized using sodium alginate as a gelling agent. The formulation showed good physicochemical characteristics and retained activity against M. furfur during 3-month accelerated stability studies. Furthermore, the developed herbal gel formulation did not show any irritation or sensitization in New Zealand rabbits after topical application, proving its cutaneous safety. Thus, topical gel formulation containing fenugreek leaf aqueous extract could be a safe and effective herbal treatment for various cutaneous fungal infections, including dandruff.

International open trial of uniform multidrug therapy regimen for leprosy patients: Findings & implications for national leprosy programmes.

BACKGROUND & OBJECTIVES: Uniform therapy for all leprosy patients will simplify leprosy treatment. In this context, we evaluated six-month multidrug therapy (MDT) currently recommended for multibacillary (MB) patients as uniform MDT (U-MDT) in a single-arm open trial under programme conditions. Primary objective was to determine efficacy to prevent five-year cumulative five per cent relapse. Secondary objectives were to assess acceptability, safety and compliance. METHODS: Newly detected, treatment-naive leprosy patients were enrolled in India (six sites) and P. R. China (two sites). Primary outcome was clinically confirmed relapse of occurrence of one or more new skin patches consistent with leprosy, without evidence of reactions post-treatment. Event rates per 100 person years as well as five-year cumulative risk of relapse, were calculated. RESULTS: A total of 2091 paucibacillary (PB) and 1298 MB leprosy patients were recruited from the 3437 patients screened. Among PB, two relapsed (rate=0.023; risk=0.11%), eight had suspected adverse drug reactions (ADRs) (rate=0.79) and rate of new lesions due toreactions was 0.24 (n=23). Rates of neuritis, type 1 and type 2 reactions were 0.39 (n=37), 0.54 (n=51) and 0.03 (n=3), respectively. Among MB, four relapsed (rate=0.07; risk=0.37%) and 16 had suspected ADR (rate=2.64). Rate of new lesions due to reactions among MB was 1.34 (n=76) and rates of neuritis, type 1 and type 2 reactions were 1.37 (n=78), 2.01 (n=114) and 0.49 (n=28), respectively. Compliance to U-MDT was 99 per cent. Skin pigmentation due to clofazimine was of short duration and acceptable. INTERPRETATION & CONCLUSIONS: We observed low relapse, minimal ADR and other adverse clinical events. Clofazimine-related pigmentation was acceptable. Evidence supports introduction of U-MDT in national leprosy programmes. [CTRI No: 2012/ 05/ 002696].

International open trial of uniform multi-drug therapy regimen for 6 months for all types of leprosy patients: rationale, design and preliminary results.

OBJECTIVE: To describe the rationale, design and preliminary results of an open trial of 6 months uniform multi-drug therapy (U-MDT) for all types of leprosy patients assuming a cumulative relapse rate not exceeding 5% over 5 years of follow-up. METHODS: We intended to recruit 2500 patients each in multi-bacillary (MB) and pauci-bacillary (PB) groups from India (five centres) and China (two centres). Standardized clinical criteria were used to assess skin lesions in the field. RESULTS: A total of 2912 patients enrolled from November 2003 to May 2007 (India, 2746; China, 166). MB patients constituted 39% and 3% had grade 2 disability. During follow-up, 27 patients (0.9%) developed new lesions. Of these, 78% were on account of reactions. Six patients had clinically confirmed relapse. Clofazimine-related skin pigmentation was short-lived and was acceptable to patients. We analysed data for clinical status of skin lesions. About 2.9% of patients were lost to follow-up; 85.9% completed treatment, of whom 19% had inactive skin lesions. PB patients responded better than MB patients (27%vs. 6%; P < 0.001). At the end of the first (n = 2013) and second year (n = 807) of follow-up post-U-MDT, in 49% and 46% patients, lesions were inactive, respectively (59% and 57% in PB, 37% and 28% in MB; P < 0.001). CONCLUSION: U-MDT appears to be promising with respect to clinical status of skin lesions.