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Potential of Fenugreek in Management of Fibrotic Disorders
Published in Dilip Ghosh, Prasad Thakurdesai, Fenugreek, 2022
Amit D. Kandhare, Sunil Bhaskaran, Subhash L. Bodhankar
Furthermore, experimental studies suggested that daily intake of anti-fibrotic fenugreek seed phytoconstituents (trigonelline, glycosides, apigenin) did not show any toxic effect during long-term administration (Kandhare, Bodhankar et al. 2016; Kandhare et al. 2019; Salehi et al. 2019; Zeiger and Tice 1997). Trigonelline demonstrated excellent safety (LD50 > 5000 mg/kg) with no adverse effects at doses 50 mg/kg for 21 days or 3500 mg for 70 days, no carcinogenicity or mutagenicity (Zeiger and Tice 1997). Acute oral toxicity study suggested flavonoid glycosides (Vicenin-1) exhibited median lethal dose (LD50) of 4837.5 mg/kg and NOAEL of 75 mg/kg during a subacute toxicity study (Kandhare, Bodhankar et al. 2016). Apigenin is considered safe, and evidence from experimental studies has shown that apigenin is non-mutagenic and non-genotoxic (Salehi et al. 2019). Moreover, fenugreek seed is a certified GRAS (Generally Recognized as Safe) ingredient (21 CFR § 182.20 2010). Thus, fenugreek seed and its phytoconstituents have a broad margin of safety and can be evaluated for further clinical development to manage fibrotic disorders.
Therapeutic effectiveness
Published in Dinesh Kumar Jain, Homeopathy, 2022
Now we should know how much time will be taken by a drug for its development? And what types of studies are required before successful development of a drug or treatment? Initial safety, biological effects, receptor study, enzyme inhibition and selectivity, drug absorption, metabolism, excretion, therapeutic efficacy, dose range, kinetics and adverse reaction, acute, subacute, chronic studies, effect on reproductive behavior, carcinogenic potential, mutagenic potential are studied and analyzed by clinical pharmacologist and physicians. Most new drug candidates are identified through chemical modification of known molecules, screening of natural products or previously discovered chemical entities for biological activity or rational drug design based on an understanding of biological mechanisms. Average ten years are taken by a drug before marketing and even after marketing surveillance is continued. If new toxicity appears after marketing, the drug is withdrawn from the market and the whole exercise of drug development becomes useless.
The Regulatory Process and Gene Therapy 1
Published in Eric Wickstrom, Clinical Trials of Genetic Therapy with Antisense DNA and DNA Vectors, 2020
Note, however, that the position of CBER does not absolutely prohibit clinical use of products with possible mutagenic effects. Even negative results from animal studies analyzed with the most sensitive techniques can only put an upper limit on the possible frequency of altered sperm, for example. Other accepted therapeutics such as some chemotherapy drugs are known to be mutagenic. The goal is to explore the issue carefully, to follow up on unexpected results, and to accumulate data that will allow full patient informed consent, including knowledgeable advice to patients in the future, and will permit an accurate risk-benefit assessment to be made.
Anti-psoriasis activities of hydroxytyrosol on HaCaT cells under psoriatic inflammation in vitro
Published in Immunopharmacology and Immunotoxicology, 2023
Caifeng Chen, Li Chen, Jun Zhou, Renhui Cai, Zhenjie Ye, Danqun Zhang
HT, the foremost phenolic component present in EVOO, is currently being actively investigated worldwide and studies demonstrated that HT exerts wide range of biological properties, including anti-inflammatory, anticancer, anti-oxidant, and anti-atherogenic [11]. It is safe even at a very high dose and that is non-genotoxic and non-mutagenic in vitro [18,19]. Furthermore, studies have showed that beneficial effects of HT could be mediated by its ability to down-regulate the activity of NF-κB, which is crucial in a number of cellular processes such as inflammation and cell proliferation in psoriasis [20,21]. HT has been widely studied in several immune-mediated dermatosis [22]. It was found to attenuate inflammatory responses of keratinocytes stimulated with IL-1 via dampening expression of IL-6, TNF-α, and IL-8 [20]. A HT-based formulation could reduce skin inflammation in reconstructed human epidermis (RHE) [23]. Furthermore, the formulation reduced IL-1α and IL-8 release in RHE [23]. It was also demonstrated that HT orally lowered the levels of TNF-α and IL-6 in mice with pristane-induced systemic lupus erythematosus (SLE) [24]. In addition, HT is more widely investigated in the prevention and treatment of UV or bluelight mediated skin damage [22,25,26]. Unfortunately, the capability of HT on psoriasis remains poorly defined.
Antibacterial activity and physicochemical properties of a sealer containing copaiba oil
Published in Biofouling, 2023
Lara Rodrigues Schneider, Andressa da Silva Barboza, Juliana Silva Ribeiro de Andrade, Daniela Coelho dos Santos, Carlos Enrique Cuevas-Suárez, Evandro Piva, Angela Diniz Campos, Rafael Guerra Lund
This study was an initial step in the search for antimicrobial materials with natural products for future use in dentistry. It is undeniable that the development of endodontic sealers with satisfactory physicochemical and biological properties is still a challenge in endodontics. In addition to AH Plus, aiming at good physical and chemical behavior, methacrylate-based resin sealers have entered the dental market, and these types of sealers include the RealSeal, which is a dual-cure material. Nevertheless, some concerns about the biocompatibility of these materials and their toxic, hypersensitive, and mutagenic properties have been raised (Reiznautt et al. 2021). Thus, the advance in modifying endodontic sealers with plant-derived phytochemicals to minimize toxicity has been progressively explored (Brezhnev et al. 2019). Some studies evaluating the cytotoxic and genotoxic effects of copaiba resin and its volatile and resinous fractions have shown good antimicrobial properties and cell compatibility. Similarly, a previous study published by our group reveals that sealers containing natural oils caused less fibroblast cell death when compared to RealSeal and AH Plus (Reiznautt et al. 2021).
Clinico-hematological, serum biochemical, genotoxic and histopathological effects of trichlorfon in adult cockerels
Published in Toxin Reviews, 2021
Riaz Hussain, Farah Ali, Muhammad Tariq Javed, Ghazalla Jabeen, Abdul Ghaffar, Iahtasham Khan, Saima Liaqat, Tariq Hussain, Rao Zahid Abbas, Asif Riaz, Shafia Tehseen Gul, Muhammad Taslim Ghori
Trichlorfon being an important member of organophosphate is frequently used in agriculture throughout the world and its volume is tremendously increasing in developing countries. The exact mechanism of trichlorfon toxicity is still under debate. However, accidental and occupational exposure to this pesticide causes serious adverse effects including cancer, mutagenic and reproductive toxicity in human beings (Fernandes et al.2015, Yonar et al.2015). Moreover, it is observed that trichlorfon inhibits acetylcholinesterase which results in accumulation of acetylcholine at nerve endings and disrupts the functions of nervous system (Fernandes et al.2015). The possible mechanisms of toxicity of trichlorfon might be because of complex tissue changes including disruption of endocrine functions, neurotoxicity, abnormalities in metabolic conditions, developmental toxicity and immunotoxicity. In published literature information regarding the toxic effects of trichlorfon in poultry is very scarce (Oliveira et al.2002). Thus, this study for the first time indicate the adverse effects of trichlorfon on physical, hemato-biochemical, histopathological, and mutagenic effects in sexually mature white leghorn male cockerels exposed to different concentrations.