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Nilesh Patel*, Dr. Janmejay Patel*, Achal Patel and Prof. Dr. Upendra U. Zala*


Aim: To evaluate acute oral toxicity of Uricare Tablet (Anti BPH Herbo-mineral formulation) on Swiss albino mice and its efficacy against Benign Prostatic Hyperplasia (BPH). Method: This study was conducted according to OECD guideline AOT-425. The IAEC no. for the study is SKPCPER/IAEC/2016-02/03. The extract was administered orally at a single oral dose of 2000 mg/kg of in sequence at 48 h intervals. The mice were observed continuously for behavioral changes, autonomic profiles and other signs of toxicity or mortality up to a period of 14 days. The body weight, food intake and water intake were also observed on 1st, 7th and 14th day. The effect of test drug was assessed on Testoviron Depot (TD) injection (2.5mg /kg /day) induced BPH in male wistar rats. The body weight, urine volume, kidney markers and physical parameters of prostate were analyzed by following provided methods at the end of study. Results: There were no physical and behavioral changes observed in Swiss albino mice during 14 days. Body weight of all animals did not reveal any significant change as compared to vehicle control group. Mortality was not observed in any animal of a group. Uricare Tablet showed significant effect on body weight, urine volume and different prostatic and biochemical parameters. All the parameters were normalized in test drug treated group. Conclusion: The study shows that Uricare Tablet (Anti BPH Herbo- Mineral formulation) does not produce any toxic effect at dose of 2000 mg/kg and normal value of kidney markers and physical prostate parameter suggests its effectiveness against BPH.

Keywords: Anti BPH Poly herbal formulation, Uricare tablet, NOAEL, Mortality, OECD Guideline.

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