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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033829
Receipt No. R000038545
Scientific Title Berberine containing quadruple therapy for initial Helicobacter Pylori eradication
Date of disclosure of the study information 2018/08/20
Last modified on 2018/08/20

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Basic information
Public title Berberine containing quadruple therapy for initial Helicobacter Pylori eradication
Acronym Berberine containing therapy for Helicobacter Pylori
Scientific Title Berberine containing quadruple therapy for initial Helicobacter Pylori eradication
Scientific Title:Acronym 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
1st name
Middle name
Last name Yu Lan
Organization Beijing Jishuitan Hospital
Division name Departement of Gastroenterology
Zip code
Address No. 31, Xinjiekou East Street, Beijing
TEL 86-10-58398289
Email lanyu-mail@sohu.com

Public contact
Name of contact person
1st name
Middle name
Last name Xiaobei Si
Organization Beijing Jishuitan Hospital
Division name Departement of Gastroenterology
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

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 07 Month 12 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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