A Clinical Study to evaluate effect of Prunus Domestica (ProsmanTM) on Benign Prostate Hyperplasia (BPH)

Dr S.N.Sankhwar; Dr.Narsingh Verma; Pravin Kumar Gangwar; Kiran Tiwari; Gopesh Lamgora

Volume : VI, Issue : VII, July - 2017

A Clinical Study to evaluate effect of Prunus Domestica (ProsmanTM) on Benign Prostate Hyperplasia (BPH)

Dr S. N. Sankhwar, Dr. Narsingh Verma, Pravin Kumar Gangwar, Kiran Tiwari, Gopesh Lamgora

Abstract :

Background: Benign prostate hyperplasia (BPH) is a non–malignant enlargement of the prostate. The majority of men over the age of 60 are considered to have urinary symptoms attributable to BPH. The active constituents of Prunus Domestica extract (Prosman^TM) include phytosterols (e.g., beta–sitosterol) that have anti–inflammatory effects by inhibiting production of pro–inflammatory prostaglandins in the prostate. Prunus also contains pentacyclic triterpenes (ursolic and oleanic acids) that have anti–edema properties, and ferulic acid esters (n–docosanol and tetracosanol) that reduce prolactin levels and block the accumulation of cholesterol in the prostate.

Objectives: The aim of the study was to evaluate the safety and efficacy of Prunus Domestica extract (Prosman^TM), in humans suffering from benign prostate hyperplasia (BPH). Material and Methods: This was an open labeled and single armed study. The study was carried out on Indian population suffering from BPH. The study was conducted at King George�s Medical University (KGMU), Lucknow. Study population comprised of males in between 40–65 years. A total of 140 subjects were included in the study. The investigation product Prunus Domestica extract (Prosman^TM) 100mg was given twice a day for 12 weeks and was allotted after screening and enrolment of the study subject. The subjects were followed up after 4 weeks, 8 weeks and 12 weeks. Safety was assessed at each follow–up visit. The efficacy of investigational product Prunus Domestica extract (Prosman^TM) in BPH subjects was evaluated by the laboratory investigations which included PSA blood test, Ultrasound and Urinary flow test. A prior ethical clearance was taken from Institutional Ethical Committee of KGMU. Statistical analysis was done by SPSS 17.0. T test was applied and a p–value of <0.05 was considered as significant.

Results: The study was conducted on 140 male study subjects in between age group 40–65 years. Average age of the study population was 56.08 years, with minimum age as 40 years and maximum age as 65 years. Prunus Domestica extract (Prosman^TM) was effective in BPH patients as reduction in the IPSS score, prostate volume and serum PSA levels were observed.

Conclusion: Prunus Domestica extract (Prosman^TM) can be labeled safe for human consumption.