Abstract

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

ABSTRACT

Introduction: Natural therapies have a long history of use in our country to support optimal prostate health. The toxicity profile of newly developed drug is requiring providing scientific base and wide acceptance. Aim: To evaluate acute oral toxicity of Urinej capsule (poly herbal formulation) on Swiss albino mice and its efficacy against Benign Prostatic Hyperplasia (BPH). Method: The protocol of present study was certified by IAEC (SKPCPER/IAEC/2016-02/03) as per the CPCSEA. The acute oral toxicity was assessed according to OECD guideline AOT-425 to know single dose (2000 mg/kg) toxicity of test drug. 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 - behavioral changes and mortality observed in any animal during 14 days. Body weight of all animals did not reveal any significant change as compared to vehicle control group. Urinej capsule 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 No-Observed- Adverse-Effect-Level (NOAEL) Urinej capsule is 2000 mg/kg as it did not have any toxic effect at that dose. Urinej capsule might inhibit the 5?-reductase enzyme. The achieved normal value of kidney markers and physical prostate parameter suggests its effectiveness against BPH.