UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034555
Receipt No. R000039392
Official scientific title of the study Berberine containing therapy for Helicobacter Pylori treatment among patients with previous failed eradication
Date of disclosure of the study information 2018/10/20
Last modified on 2018/10/17

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Official scientific title of the study Berberine containing therapy for Helicobacter Pylori treatment among patients with previous failed eradication
Title of the study (Brief title) 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 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 Xiao-bei 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

Other related organizations
Co-sponsor
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

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

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2018 Year 09 Month 01 Day
Anticipated trial start date
2018 Year 09 Month 01 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 Partially published
URL releasing results
Results
Other related information

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


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.