drugset / Trial / NCT03829904
The Effect of Traditional Chinese Medicine on Benign Prostatic Hyperplasia
RandomizedCrossoverDouble-blindTreatment
Summary
This randomized, double-blinded, placebo-controlled, crossover clinical trial aims to investigate the effect of VGH-BPH1, a scientific Chinese medicine powder prescription, on patients with benign prostatic hyperplasia.
Timeline
- Start
- 2019-03-06
- Primary completion
- 2020-01-02
- Completion
- 2020-01-02
Publications
- Background Nickel JC. The overlapping lower urinary tract symptoms of benign prostatic hyperplasia and prostatitis. Curr Opin Urol. 2006 Jan;16(1):5-10. doi: 10.1097/01.mou.0000193365.46081.cd.
- Background Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U, van Kerrebroeck P, Victor A, Wein A; Standardisation Sub-committee of the International Continence Society. The standardisation of terminology of lower urinary tract function: report from the Standardisation Sub-committee of the International Continence Society. Neurourol Urodyn. 2002;21(2):167-78. doi: 10.1002/nau.10052. No abstract available.
- Background Barqawi AB, Myers JB, O'Donnell C, Crawford ED. The effect of alpha-blocker and 5alpha-reductase inhibitor intake on sexual health in men with lower urinary tract symptoms. BJU Int. 2007 Oct;100(4):853-7. doi: 10.1111/j.1464-410X.2007.07092.x. Epub 2007 Jul 23.
- Background Miner M, Rosenberg MT, Perelman MA. Treatment of lower urinary tract symptoms in benign prostatic hyperplasia and its impact on sexual function. Clin Ther. 2006 Jan;28(1):13-25. doi: 10.1016/j.clinthera.2006.01.004.
- Background Jung JH, Jae SU, Kam SC, Hyun JS. Correlation between Lower Urinary Tract Symptoms (LUTS) and sexual function in benign prostatic hyperplasia: impact of treatment of LUTS on sexual function. J Sex Med. 2009 Aug;6(8):2299-304. doi: 10.1111/j.1743-6109.2009.01324.x. Epub 2009 Jun 2.
- Background Sarma AV, Wei JT. Clinical practice. Benign prostatic hyperplasia and lower urinary tract symptoms. N Engl J Med. 2012 Jul 19;367(3):248-57. doi: 10.1056/NEJMcp1106637. No abstract available.
- Background Pasko P, Rodacki T, Domagala-Rodacka R, Owczarek D. Interactions between medications employed in treating benign prostatic hyperplasia and food - A short review. Biomed Pharmacother. 2016 Oct;83:1141-1145. doi: 10.1016/j.biopha.2016.08.021. Epub 2016 Aug 20.
- Background Tacklind J, Fink HA, Macdonald R, Rutks I, Wilt TJ. Finasteride for benign prostatic hyperplasia. Cochrane Database Syst Rev. 2010 Oct 6;2010(10):CD006015. doi: 10.1002/14651858.CD006015.pub3.
- Background Corona G, Tirabassi G, Santi D, Maseroli E, Gacci M, Dicuio M, Sforza A, Mannucci E, Maggi M. Sexual dysfunction in subjects treated with inhibitors of 5alpha-reductase for benign prostatic hyperplasia: a comprehensive review and meta-analysis. Andrology. 2017 Jul;5(4):671-678. doi: 10.1111/andr.12353. Epub 2017 Apr 28.
- Background Li MK, Garcia L, Patron N, Moh LC, Sundram M, Leungwattanakij S, Pripatnanont C, Cheng C, Chi-Wai M, Loi-Cheong N. An Asian multinational prospective observational registry of patients with benign prostatic hyperplasia, with a focus on comorbidities, lower urinary tract symptoms and sexual function. BJU Int. 2008 Jan;101(2):197-202. doi: 10.1111/j.1464-410X.2007.07320.x. Epub 2007 Nov 13.
- Background Wilt TJ, Ishani A, Stark G, MacDonald R, Lau J, Mulrow C. Saw palmetto extracts for treatment of benign prostatic hyperplasia: a systematic review. JAMA. 1998 Nov 11;280(18):1604-9. doi: 10.1001/jama.280.18.1604.
- Background Pagano E, Laudato M, Griffo M, Capasso R. Phytotherapy of benign prostatic hyperplasia. A minireview. Phytother Res. 2014 Jul;28(7):949-55. doi: 10.1002/ptr.5084.
- Background Keehn A, Lowe FC. Complementary and alternative medications for benign prostatic hyperplasia. Can J Urol. 2015 Oct;22 Suppl 1:18-23.
- Background Ho CC, Singam P, Hong GE, Zainuddin ZM. Male sexual dysfunction in Asia. Asian J Androl. 2011 Jul;13(4):537-42. doi: 10.1038/aja.2010.135. Epub 2011 Jun 6.
- Background Yagi H, Sato R, Nishio K, Arai G, Soh S, Okada H. Clinical efficacy and tolerability of two Japanese traditional herbal medicines, Hachimi-jio-gan and Gosha-jinki-gan, for lower urinary tract symptoms with cold sensitivity. J Tradit Complement Med. 2015 Apr 18;5(4):258-61. doi: 10.1016/j.jtcme.2015.03.010. eCollection 2015 Oct.
- Background Chen F, Li HL, Li YH, Tan YF, Zhang JQ. Quantitative analysis of the major constituents in Chinese medicinal preparation SuoQuan formulae by ultra fast high performance liquid chromatography/quadrupole tandem mass spectrometry. Chem Cent J. 2013 Jul 30;7(1):131. doi: 10.1186/1752-153X-7-131.
- Background Ge FH, Ma XP, Ma JF, Bi CQ, Chen TL, Zhang XD, Xiao X. Qualitative and Quantitative Characterization of Monosaccharide Components of Salvia miltiorrhiza, Liguspyragine Hydrochloride, and Glucose Injection. J Anal Methods Chem. 2017;2017:9245620. doi: 10.1155/2017/9245620. Epub 2017 Apr 11.
- Background Chen F, Li L, Tian DD. Salvia miltiorrhiza Roots against Cardiovascular Disease: Consideration of Herb-Drug Interactions. Biomed Res Int. 2017;2017:9868694. doi: 10.1155/2017/9868694. Epub 2017 Apr 3.
- Background Bonesi M, Loizzo MR, Acquaviva R, Malfa GA, Aiello F, Tundis R. Anti-inflammatory and Antioxidant Agents from Salvia Genus (Lamiaceae): An Assessment of the Current State of Knowledge. Antiinflamm Antiallergy Agents Med Chem. 2017;16(2):70-86. doi: 10.2174/1871523016666170502121419.
- Background Jiang G, Liu J, Ren B, Zhang L, Owusu L, Liu L, Zhang J, Tang Y, Li W. Anti-tumor and chemosensitization effects of Cryptotanshinone extracted from Salvia miltiorrhiza Bge. on ovarian cancer cells in vitro. J Ethnopharmacol. 2017 Jun 9;205:33-40. doi: 10.1016/j.jep.2017.04.026. Epub 2017 Apr 27.
- Background Deng Y, Long L, Wang K, Zhou J, Zeng L, He L, Gong Q. Icariside II, a Broad-Spectrum Anti-cancer Agent, Reverses Beta-Amyloid-Induced Cognitive Impairment through Reducing Inflammation and Apoptosis in Rats. Front Pharmacol. 2017 Feb 2;8:39. doi: 10.3389/fphar.2017.00039. eCollection 2017.
- Background Mo ZT, Li WN, Zhai YR, Gao SY. The effects of icariin on the expression of HIF-1alpha, HSP-60 and HSP-70 in PC12 cells suffered from oxygen-glucose deprivation-induced injury. Pharm Biol. 2017 Dec;55(1):848-852. doi: 10.1080/13880209.2017.1281968.
- Background Li XA, Ho YS, Chen L, Hsiao WL. The Protective Effects of Icariin against the Homocysteine-Induced Neurotoxicity in the Primary Embryonic Cultures of Rat Cortical Neurons. Molecules. 2016 Nov 22;21(11):1557. doi: 10.3390/molecules21111557.
- Background Chen KK, Chiu JH. Effect of Epimedium brevicornum Maxim extract on elicitation of penile erection in the rat. Urology. 2006 Mar;67(3):631-5. doi: 10.1016/j.urology.2005.09.051.
- Background Chang CM, Wu PC, Chiang JH, Wei YH, Chen FP, Chen TJ, Pan TL, Yen HR, Chang HH. Integrative therapy decreases the risk of lupus nephritis in patients with systemic lupus erythematosus: A population-based retrospective cohort study. J Ethnopharmacol. 2017 Jan 20;196:201-212. doi: 10.1016/j.jep.2016.12.016. Epub 2016 Dec 12.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | VGH-BPH1 | Traditional medicine (herbal / TCM) | 5.3 g | — |