UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033829 |
|---|---|
| Receipt number | 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 20:51:16 |
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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
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
sixiaobei2008@126.com
Sponsor or person
Institute
Health bureau of Beijing
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038545
