UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Berberine containing quadruple therapy for initial Helicobacter Pylori eradication
Title of the study (Brief title)	Berberine containing therapy for Helicobacter Pylori
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	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	eradication rate of H. pylori
Key secondary outcomes	side effects rate during therapy

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

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 Clarithromycin 500mg bid) for 14 days
Interventions/Control_2	Bismuth Containing Quadruple Therapy (Rabeprazole 10mg bid, Bismuth 500mg bid, Amoxicillin 1g bid and Clarithromycin 500mg 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
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 Patients with previous eradication therapy;
Target sample size	100

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

Public contact
Name of contact person	Xiaobei Si
Organization	Beijing Jishuitan Hospital
Division name	Departement of Gastroenterology
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	P. R. China

Other related organizations
Co-sponsor	No
Name of secondary funｄer(s)

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	Beijing Jishuitan Hospital (Beijing)

Other administrative information
Date of disclosure of the study information	2018 Year 08 Month 20 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2018 Year 07 Month 12 Day
Anticipated trial start date	2018 Year 08 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 08 Month 20 Day
Last modified on	2018 Year 08 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038545