UMIN-CTR Clinical Trial

Basic information
Public title	Berberine containing therapy for Helicobacter Pylori treatment among patients with previous failed eradication
Acronym	Berberine containing therapy for patients with previous failed helicobacter pylori eradication
Scientific Title	Berberine containing therapy for Helicobacter Pylori treatment among patients with previous failed eradication
Scientific Title:Acronym	Berberine containing therapy for patients with previous failed helicobacter pylori eradication
Region	Asia(except Japan)

Condition
Condition	H. pylori infection
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare the therapy efficacy (eradication rate) and safety between Bismuth Containing Quadruple Therapy (BCQT) and Berberine Containing Therapy (BCQT plus berberine)
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	eradication rate of H. pylori
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Berberine Containing Therapy (Berberine 0.3g tid, Rabeprazole 10mg bid, Bismuth 500mg bid, Amoxicillin 1g bid and Minocycline 1000mg bid) for 14 days
Interventions/Control_2	Bismuth Containing Quadruple Therapy (Rabeprazole 10mg bid, Bismuth 500mg bid, Amoxicillin 1g bid and Minocycline 1000mg bid) for 14 days
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients positive to Rapid Urease Test Patients positive to 13C Urease Breath Test Patients verified of Hp infection with pathology Patients with previous failed H. pylori eradication
Key exclusion criteria	Patients with allergy history of drugs medicated in this trail Patients with history of hepatic or/and renal dysfunction Patients with history of operation on upper digestive tract Patients with alcoholism and drug abuse Patients in pregnancy or lactation Patients who ever participated other clinical trials in latest 3 months
Target sample size	90

Research contact person
Name of lead principal investigator	1st name Yu Middle name Last name Lan
Organization	Beijing Jishuitan Hospital
Division name	Departement of Gastroenterology
Zip code	100035
Address	No. 31, Xinjiekou East Street, Beijing
TEL	86-10-58398289
Email	lanyu-mail@sohu.com

Public contact
Name of contact person	1st name Xiao-Bei Middle name Last name Si
Organization	Beijing Jishuitan Hospital
Division name	Departement of Gastroenterology
Zip code	100035
Address	No. 31, Xinjiekou East Street, Beijing
TEL	86-10-58398289
Homepage URL
Email	sixiaobei2008@126.com

Sponsor
Institute	Health bureau of Beijing
Institute
Department

Funding Source
Organization	Administration of traditional Chinese medicine of Beijing
Organization
Division
Category of Funding Organization	Government offices of other countries
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Beijing Jishuitan Hospital
Address	No. 31, Xinjiekou East Street, Beijing
Tel	86-10-58398289
Email	sixiaobei2008@126.com

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2018 Year 10 Month 20 Day

Related information
URL releasing protocol
Publication of results	Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2018 Year 09 Month 01 Day
Date of IRB	2018 Year 09 Month 10 Day
Anticipated trial start date	2018 Year 09 Month 01 Day
Last follow-up date	2019 Year 12 Month 20 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 10 Month 17 Day
Last modified on	2019 Year 12 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039392