Clinical evaluation of polyherbal formulation (Uricare Tablet) in benign prostatic hyperplasia: randomized, placebo controlled, single blinded clinical study
Keywords:BPH, IPSS, QOL, PSA, Prostate volume
Background: This was a randomized, placebo controlled, single blinded clinical trial undertaken in 60 male patients in the age group of 18-70 years diagnosed with benign prostatic hyperplasia (BPH) in the department of at P.D. Patel Kayachikitsha, Ayurveda Hospital, India.
Methods: A medical history, especially on urinary symptoms was obtained from all patients on first visit along with Blood tests. 60 Patients were randomized into two groups. Uricare tablet was administered at the dose of 2 tablets twice a day for the period of 6 weeks to treatment group and Placebo tablet was administered with same doses to the remaining patients group. They were evaluated on BPH assessment parameters, IPSS (International prostate symptom score), quality of life (QOL), level of serum PSA and the prostate volume.
Results: Percentage reduction in IPSS score was observed 25.62% and 1.80% in treatment and placebo group respectively. Percentage improvement in QOL was also observed 31.67% and 2.82% in treatment and placebo groups respectively. BPH assessment parameters also show moderate changes in before and after treatment in both groups. However, the reduction in prostate volume was identified up to -4.612cc and -1.427cc in treatment and placebo group respectively at the end of the trial. Prostate significant antigen (PSA) was significantly reduced in the treatment group than Placebo group.Conclusions:There were no serious adverse effects observed during the study. Hence, the therapy was assumed to be well tolerated by patients and can be considered as a drug of choice in the management of BPH.
Tortora GJ, Derrickson B. In: Principles of Anatomy and Physiology. 13th Ed, John Wiley & Sons; 2012.
Sahu M, Bhat R, Kulkarni KS. Clinical evaluation of Himplasia in Benign Prostatic Hyperplasia: An Open Clinical Trial. Medicine Update. 2003;11(1): 75-8.
Fang-liu G. Incidence of benign prostatic hyperplasia and prostatic cancer in China. Chinese J. Surg, 1993;31:323-6.
Vyas BA, Desai NY, Patel PK, Joshi SV, Shah DR. Effect of Boerhaavia diffusa in experimental prostatic hyperplasia in rats. Indian Journal of Pharmacology. 2013;45(3):264-9.
Sakthivel E, Jayshree N. Pharmacological evaluation of a polyherbal formulation for the Management of benign prostatic hyperplasia. International Journal of Current Pharmaceutical Research. 2013;5(1):8-12.
Chakraborthy S, Karamakar D, Kolhapure SA. Evaluation of the efficacy and safety of Himplasia in BPH: A randomised, double-blind, placebo-controlled, phase III clinical trial. Medicine Update. 2004;12(4):39-48.
Kapur P, Pereira BM, Wuttke W, Jarry H. Androgenic action of Tinospora cordifolia extract inn prostate cancer cell line LNCaP. Phytomedicine. 2009;16(6-7):679-82.
Khattar V, Wal A. Utilities of Crataeva nurvala. International Journal of Pharmacy and Pharmaceutical Sciences. 2012;4(4):21-6.
Poonia P, Mittak SK, Gupta VK, Singh J. Gum guggul: An Ayurvedic Boom. International Journal of Pharmacognosy and Phytochemical Research 2014; 6(2):347-54.
Jeyaraman R, Patki PS. Clinical Evaluation of Efficacy and Safety of a Herbal Formulation in Benign Prostatic Hyperplasia: A Single Blind, Randomized, Placebo-Controlled Study. Open Journal of Urology. 2012;2:157-63.
Why Are Coffee & Tea Bad for the Prostate?, Available
at URL: http://www.livestrong.com/article/517812-why-are-coffee-tea-bad-for-the-prostate/. Accessed on May 2016.
BPH and Caffeine, Available at URL: http://www.prostate.net/2011/nutrition/coffee-caffeine-bph-and-prostate-cancer/. Accessed on May 2016.