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Panchkula, India

Swaroop A.,Cepham Research Center | Bagchi M.,Cepham Research Center | Kumar P.,Chemical Resources | Preuss H.G.,Georgetown University | And 2 more authors.
Toxicology Mechanisms and Methods | Year: 2015

The efficacy of a novel Prunus domestica bark extract (Sitoprin, CR002) was investigated on testosterone propionate (TP)-induced benign prostatic hyperplasia (BPH) in male Wistar rats. BPH was induced by daily subcutaneous administration of TP (3.0 mg/kg) over a period of 15 days (interim sacrifice group) and for an additional 21 days (terminal sacrifice group). We evaluated the dose-dependent efficacy (0, 50, 100 and 200 mg/kg body weight/day) of CR002 and a control group against BPH, and compared with a reference standard Prunus africana extract (CR001). Extensive clinical examinations were carried out on days 1, 7, 14, 21, 28 and 35 of treatment period to determine the onset, duration and severity of clinical signs. Clinical pathology, hematology, biochemistry and histopathology were performed on days 15 and 35, prior to necropsy. Animals were fasted overnight prior to blood collection. Prostate glands and tissues were examined. On day 36, histopathology of ventral prostrate of control rats demonstrates single layer of columnar mucin secreting epithelial cells along with a lumen occupied with eosinophilic secretion. In contrast, CR002 and CR001 groups (100 and 200 mg/kg/day) exhibited no hyperplasia and proliferation of epithelial cells. Prostate histopathology of these treated groups was comparable with control rats. The hyperplasia and hypertrophy of prostrate was reduced to single-layered cell indicating the efficacy of CR002 and CR001. Overall, results demonstrate that CR002 exhibits therapeutic efficacy/activity in TP-induced BPH in rats, which is comparable to CR001. © 2015 Taylor & Francis. Source


Swaroop A.,Cepham Research Center | Jaipuriar A.S.,Jaipuriar Cardiac Center and Garg Hospital | Gupta S.K.,Hormone and Maternity Clinic | Bagchi M.,Cepham Research Center | And 4 more authors.
International Journal of Medical Sciences | Year: 2015

Polycystic ovary syndrome (PCOS) is one of the most prevalent hormonal disorders among women of reproductive age causing irregular menstrual cycles, excessive body or facial hair, miscarriage and infertility. The latter being a most common PCOS symptoms. Because the symptoms are seemingly unrelated to one another, PCOS is often overlooked and undiagnosed. The present study is an open label, one-arm, non-randomized, post-marketing surveillance study in 50 premenopausal women (18-45 years, BMI<42) diagnosed with PCOS using a novel Trigonella foenum-graecum seed extract (fenugreek seed extract, Furocyst, 2 capsules of 500 mg each/day) extract, enriched in approximately 40% furostanolic saponins, over a period of 90 consecutive days. The study was conducted to determine its efficacy on the reduction of ovarian volume and the number of ovarian cysts. Ethical committee approval was obtained for this study. Furocyst treatment caused significant reduction in ovary volume. Approximately 46% of study population showed reduction in cyst size, while 36% of subjects showed complete dissolution of cyst. It is important to mention that 71% of subjects reported the return of regular menstrual cycle on completion of the treatment and 12% of subjects subsequently became pregnant. Overall, 94% of patients benefitted from the regimen. Significant increases in luteinizing hormone (LH) and follicular stimulating hormone (FSH) levels were observed compared to the baseline values. Extensive blood chemistry, hematological and biochemical assays demonstrated the broad-spectrum safety. Furocyst caused significant decrease in both ovarian volume and the number of ovarian cysts. Serum ALT, BUN and CK were assessed to demonstrate the broad-spectrum safety of Furocyst. No significant adverse effects were observed. In summary, Furocyst was efficacious in ameliorating the symptoms of PCOS. © 2015 Ivyspring International Publisher. Source


Swaroop A.,Cepham Research Center | Bagchi M.,Cepham Research Center | Kumar P.,Chemical Resources | Preuss H.G.,Georgetown University | Bagchi D.,University of Houston
Toxicology Mechanisms and Methods | Year: 2015

The efficacy of a novel Prunus domestica bark extract (Sitoprin, CR002) was investigated on testosterone propionate (TP)-induced benign prostatic hyperplasia (BPH) in male Wistar rats. BPH was induced by daily subcutaneous administration of TP (3.0 mg/kg) over a period of 15 days (interim sacrifice group) and for an additional 21 days (terminal sacrifice group). We evaluated the dose-dependent efficacy (0, 50, 100 and 200 mg/kg body weight/day) of CR002 and a control group against BPH, and compared with a reference standard Prunus africana extract (CR001). Extensive clinical examinations were carried out on days 1, 7, 14, 21, 28 and 35 of treatment period to determine the onset, duration and severity of clinical signs. Clinical pathology, hematology, biochemistry and histopathology were performed on days 15 and 35, prior to necropsy. Animals were fasted overnight prior to blood collection. Prostate glands and tissues were examined. On day 36, histopathology of ventral prostrate of control rats demonstrates single layer of columnar mucin secreting epithelial cells along with a lumen occupied with eosinophilic secretion. In contrast, CR002 and CR001 groups (100 and 200 mg/kg/day) exhibited no hyperplasia and proliferation of epithelial cells. Prostate histopathology of these treated groups was comparable with control rats. The hyperplasia and hypertrophy of prostrate was reduced to single-layered cell indicating the efficacy of CR002 and CR001. Overall, results demonstrate that CR002 exhibits therapeutic efficacy/activity in TP-induced BPH in rats, which is comparable to CR001. © 2015 Taylor & Francis. Source


Swaroop A.,Cepham Inc. | Bagchi M.,Cepham Inc. | Kumar P.,Chemical Resources | Preuss H.G.,Georgetown University | And 4 more authors.
Toxicology Mechanisms and Methods | Year: 2014

Safety and anti-diabetic efficacy of a novel, proprietary Trigonella foenum-graecum seed extract [novel fenugreek extract (FE), Fenfuro™, CR0010810) enriched in furostanolic saponins (>60% w/w, HPLC) were assessed. Concerning safety, we undertook studies dealing with acute oral toxicity, 28-d sub-chronic toxicity and Ames' bacterial reverse mutation assay that revealed no toxicity. Concerning efficacy, we examined beneficial effects of the extract on rats with type 2 diabetes (T2D). Male Sprague-Dawley rats received a high-fat diet for 2 weeks followed by streptozotocin (STZ, 35mg/kg i.p.) to produce T2D. Seven days post-STZ, rats showing ≥300mg/dl fasting plasma glucose level (PGL) were included in the study. FE (150-or 450-mg/kg p.o.) and glipizide (5mg/kg p.o.) were administered once daily for 20d and then twice daily for another 10d (total 30d). Blood samples were collected at 0, 10, 20 and 30d of treatment and estimated for fasting plasma triglyceride (PTG), total cholesterol and insulin levels. After 30d, FE and glipizide-treated diabetic animals were treated in combination with or without metformin (100mg/kg) twice daily for another 10d. FE did not influence body weight, feed and water intake. FE (150mg/kg p.o.) reduced PTG levels in T2D rats by 22%, 24.6% and 29% at 10, 20 and 30d of treatment, respectively, while glipizide (5mg/kg p.o.) reduced the PTG levels by 57.4%, 46.2% and 39.4% at these time points. FE (450mg/kg) treatment in STZ-induced diabetic rats produced significant hypoglycemic activity (approximately 31.5%) as compared to insulin (48.2% with 1 U/kg i.p.). FE (150mg/kg p.o.) and metformin (100mg/kg p.o.) combined produced significant reduction (20.7%) of PGL in T2D rats. No adverse effects were observed. We conclude after extensive in vitro and in vivo safety and efficacy studies that FE is safe and effective in treating T2D. © 2014 Informa Healthcare USA, Inc. Source


Rohilla M.,Panjab University | Goel N.,Panjab University | Singh T.V.,Panjab University | Venugopalan P.,Panjab University | And 2 more authors.
International Journal of Quantum Chemistry | Year: 2013

Lysergol, elymoclavine (Δ9,10 and Δ8,9 regioisomers), and dihydrolysergol are important members of ergolines. The present work reports their comparative study in gas and solvent phase (water) that has been performed both experimentally and theoretically. Theortical calculations have been carried within the density functional theory formalism to analyze the structural and electronic properties of these molecules with B3LYP hybrid exchange-correlational fuctional in conjunction with 6-311++G (d,p) basis set. Hessian calculations are performed at B3LYP/6-31G (d,p) level of theory in gas phase as well as other solvent phases. Solvent phase calculations are performed using Onsager reaction field model as implemented in Gaussian 03. A good agreement has been found between experimental and theoretical infrared and nuclear magnetic resonance (NMR) spectra. The calculated NMR data has been analyzed statistically. Stability of these regioisomers has been analyzed in terms of the energy gap between highest occupied molecular orbital and lowest unoccupied molecular orbital (HOMO-LUMO gap). Calculations for lysergol and elymoclavine in water as solvent were carried to examine the effect of solvent on the HOMO-LUMO levels and energy of these molecules. © 2012 Wiley Periodicals, Inc. Source

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