Potential benefits of oral administration of AMORPHOPHALLUS KONJAC glycosylceramides on skin health - a randomized clinical study.

BACKGROUND: Ceramides play a fundamental role in maintaining the skin health as a function of improved barrier permeability. Reduced ceramide content results in skin dryness and wrinkledness. Intake of dietary ceramides potentially compensates the skin ceramide content. In the present study we have assessed the skin health benefits of oral supplementation of a hydroalcoholic extract from Amorphophallus konjac tubers standardized to 5% glycosylceramides, in a placebo-controlled clinical trial. METHODS: Fifty-one healthy human volunteers (aged 18-60 years) were supplemented with 100 mg/day of either a placebo or A. konjac extract capsules (5 mg glycosylceramides) for 6-weeks. The skin parameters were evaluated through dermatological diagnosis. Subject perceived efficacy of the product was further evaluated by a self-assessment questionnaire. RESULTS: Oral intake of A. konjac extract significantly decreased the skin dryness, hyperpigmentation, redness, itching and oilyness (p < 0.05). The improvement in skin health following intake of A. konjac extract was observed to be time-dependent from the start. Further, A. konjac extract was well-tolerated throughout the study, as no adverse events or toxic changes were recorded. CONCLUSION: The study demonstrates the skincare properties of orally ingested glycosyl ceramides from konjac tubers. TRIAL REGISTRATION: CTRI/2018/12/016661 dated 13/12/2018 retrospectively registered, http://ctri.nic.in/Clinicaltrials/showallp.php?mid1=19851&EncHid=&userName=SkinCera.

Sub-acute and acute toxicity of Ferula asafoetida and Silybum marianum formulation and effect of the formulation on delaying gastric emptying.

BACKGROUND: Delayed gastric emptying play an important role in the pathology of functional dyspepsia. Owing to their functional attributes in alleviating the gastrointestinal disorders, single or polyherbal formulations have gained attention to treat the symptoms of functional dyspepsia. We have investigated the safety and efficacy of a novel formulation of Ferula asafoetida oleo resin and standardized Silybum marianum extract (Asdamarin). METHODS: The effect of asdamarin on delayed gastric emptying was investigated in Sprague Dawley rats using phenol red method. The acute and sub-acute oral toxicity was evaluated in wistar rats following OECD guidelines 425 and 407 respectively. The data were analyzed by one-way ANOVA using GraphPad Prism 5.0 software. RESULTS: Oral administration of Asdamarin dose-dependently improved the delay in gastric emptying as evident from the significant increase in the gastrointestinal transit time (p < 0.001). The LD50 of asdamarin was estimated to be more than 2000 mg/kg. Further, in the 28-day sub-acute toxicity study, the administration of 250, 500 and 1000 mg/kg of Asdamarin did not significantly altered the feed and water consuption, body weight change, biochemical and haematological parameters compared to control animals. Macroscopic and histopathological examination of vital organs revealed no toxic signs. CONCLUSION: The preliminary data from the present study provides the first evidence on the possible effectiveness of novel formulation of F. Asafoatida and S. marianum extracts in alleviating the associated symptoms of functional dyspepsia. The toxicity data indicated that Asdamarin can be considered safe up to 1000 mg/kg dose.