Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2026-02-26 @ 6:53 AM
Study NCT ID:
NCT03829904
Status:
COMPLETED
Last Update Posted:
2020-04-13
First Post:
2019-01-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Traditional Chinese Medicine on Benign Prostatic Hyperplasia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011470', 'term': 'Prostatic Hyperplasia'}], 'ancestors': [{'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013213', 'term': 'Starch'}], 'ancestors': [{'id': 'D005936', 'term': 'Glucans'}, {'id': 'D001704', 'term': 'Biopolymers'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D004040', 'term': 'Dietary Carbohydrates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D011134', 'term': 'Polysaccharides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Placebo is manufactured to have the same appearance with VGH-BPH1, after that VGH-BPH1 and placebo will be coded as package A and B by the manufacturer and the codes will only be revealed after the study ends. Therefore, patients and investigators will not know which package is VGH-BPH1 or placebo.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': '40 participants will be recruited from Division of Urology in a Medical Center. They will be randomizedly allocated into treatment and control groups, each including 20 participants. After eight weeks of taking, there is a two weeks of drug wash-out period. And then two groups will be switched for another eight weeks. The study duration is totally 18 weeks.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2020-01-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-09', 'studyFirstSubmitDate': '2019-01-24', 'studyFirstSubmitQcDate': '2019-02-01', 'lastUpdatePostDateStruct': {'date': '2020-04-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'International prostate symptom score (IPSS)', 'timeFrame': 'Change from Baseline IPSS at eight weeks, ten weeks, eighteen weeks', 'description': 'To measure the severity of lower urinary tract symptoms. Each item is scored 0-5, yielding a total between 0-35.'}, {'measure': 'Aging Male Symptoms score (AMS)', 'timeFrame': 'Change from Baseline AMS at eight weeks, ten weeks, eighteen weeks', 'description': 'To evaluate health-related quality of life in aging men. Each item is scored 1-5, yielding a total between 17-85.'}], 'secondaryOutcomes': [{'measure': 'Constitution in Chinese Medicine Questionnaire (CCMQ)', 'timeFrame': 'Change from Baseline CCMQ at eight weeks, ten weeks, eighteen weeks', 'description': 'It has 60 items measuring the 9 body constitution types: gentleness, Qi-deficiency, Yang-deficiency, Yin-deficiency, phlegm-wetness, wetness-heat, blood-stasis, Qi-depression, and special diathesis.'}, {'measure': 'Post-voiding residual urine', 'timeFrame': 'Change from Baseline post-voiding residual urine at eight weeks, ten weeks, eighteen weeks', 'description': 'To measure and compare the amount of urine left in the bladder after urination before and after treatment.'}, {'measure': 'International index of erectile function (IIEF)', 'timeFrame': 'Change from Baseline IIEF at eight weeks, ten weeks, eighteen weeks', 'description': 'To evaluate male sexual function over the past 6 months. Each item is scored 1-5, yielding a total between 5-25.'}, {'measure': 'Maximum flow rate (Qmax) and Average flow rate (Qave）', 'timeFrame': 'Change from Baseline Qmax and Qave at eight weeks, ten weeks, eighteen weeks', 'description': 'To determine peak urine flow rate and average urine flow rate. They are calculated by ml/sec.'}, {'measure': 'Voided volume (VV)', 'timeFrame': 'Change from Baseline VV at eight weeks, ten weeks, eighteen weeks', 'description': 'To calculate the amount of urine (ml)'}, {'measure': 'Voiding time and time to maximum flow', 'timeFrame': 'Change from Baseline Voiding time and time to maximum flow at eight weeks, ten weeks, eighteen weeks', 'description': 'To calculate the length of time it takes to empty bladder completely and the peak urine flow time (sec)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Benign Prostatic Hyperplasia', 'Traditional Chinese medicine'], 'conditions': ['Benign Prostatic Hyperplasia']}, 'referencesModule': {'references': [{'pmid': '16385194', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '11857671', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '17662074', 'type': 'BACKGROUND', 'citation': "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."}, {'pmid': '16490576', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '19493292', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '22808960', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '27551761', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '20927745', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '28453908', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '18005205', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '9820264', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '25165780', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '26497340', 'type': 'BACKGROUND', 'citation': 'Keehn A, Lowe FC. Complementary and alternative medications for benign prostatic hyperplasia. Can J Urol. 2015 Oct;22 Suppl 1:18-23.'}, {'pmid': '21643001', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '26587398', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '23899222', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '28487814', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '28473993', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '28464779', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '28456578', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '28210222', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '28140748', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '27879670', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '16527595', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '27974236', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'Benign prostatic hyperplasia (BPH) is an enlargement of the prostate gland due to progressive hyperplasia of the stromal and glandular cells.\n\nThe aim of this study is to evaluate the efficacy of traditional Chinese medicine (VGH-BPH1) in treating patients with BPH, by using the experimental BPH-1 powder, including Ji Sheng Shen Qi Wan and Sangpiaoxiao powder as the main prescription, and adding Wuyao, Yizhiren, Danshen, Yinyanghuo, Fupenzi, Huangbo and Zhimu as auxiliary ingredients, to form a 5gm per pack. This study is designed as a double-blinded randomized placebo-controlled cross-over trial to provide experimental evidence and feasibility of traditional Chinese medicine VGH-BPH1 in the treatment of BPH, and to analyze the syndrome pattern of Chinese medicinal prescriptions for subgroups of BPH.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'genderBased': True, 'genderDescription': 'Male patients who have been diagnosed with benign prostatic hyperplasia', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who have been diagnosed with benign prostatic hyperplasia by a urologist\n* Have been treated with conventional first-line western medicine for more than three months\n* Patients with moderate to severe benign prostatic hyperplasia (IPSS score \\>12 points)\n* Participate voluntarily in the study\n\nExclusion Criteria:\n\n* At the same time, use other Chinese herbal medicines or alternative medicine (including drugs and acupuncture) for more than one month.\n* Syphilis, gonorrhea and other sexually transmitted diseases or urinary tract infections\n* Urinary tract stones, prostate cancer, bladder cancer or acute and chronic renal failure\n* Congenital abnormalities such as bladder neck fibrosis, interstitial cystitis or urethral stricture\n* A history of genital trauma or surgery affecting the muscle or nervous system\n* Patients with upper urinary tract obstruction, renal edema, etc. affecting renal function\n* Unable to sign a consent form or unable to communicate with researchers'}, 'identificationModule': {'nctId': 'NCT03829904', 'briefTitle': 'The Effect of Traditional Chinese Medicine on Benign Prostatic Hyperplasia', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Taipei Veterans General Hospital, Taiwan'}, 'officialTitle': 'The Effect of Traditional Chinese Medicine VGH-BPH1 on Patients With Benign Prostatic Hyperplasia: A Double-blinded Randomized Placebo-controlled Cross-over Study', 'orgStudyIdInfo': {'id': '2018-01-019C'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'VGH-BPH1 group', 'description': 'VGH-BPH1 includes Ji Sheng Shen Qi Wan 2.5g, Sangpiaoxiao powder 1.0g, Wuyao 0.3g, Yizhiren 0.3g, Danshen 0.3g, Yinyanghuo 0.3g, Fupenzi 0.1g, Huangbo 0.25g and Zhimu 0.25g, three times per day, each serving a small packet of 5.3 grams of concentrated granules.', 'interventionNames': ['Drug: VGH-BPH1']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'Placebo includes corn starch plus caramel coloring, and added 1/100 VGH-BHP1 compound, three times per day, each serving a small packet of 5.3 grams of concentrated granules.', 'interventionNames': ['Drug: Placebo (Corn starch pill manufactured to mimic VGH-BPH1)']}], 'interventions': [{'name': 'VGH-BPH1', 'type': 'DRUG', 'description': 'A scientific Chinese granule powder', 'armGroupLabels': ['VGH-BPH1 group']}, {'name': 'Placebo (Corn starch pill manufactured to mimic VGH-BPH1)', 'type': 'DRUG', 'description': 'Corn starch pill manufactured to mimic VGH-BPH1', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '112', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Taipei Veterans General Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Shinn-Jang Hwang, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Taipei Veterans General Hospital, Taiwan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taipei Veterans General Hospital, Taiwan', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}