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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003092
Receipt No. R000003734
Scientific Title The exploratory study for the efficacy and the safety of rikkunshito on symptoms of upper gastrointestinal tract in the patients with gastroesophageal reflux disease (GERD)
Date of disclosure of the study information 2010/01/26
Last modified on 2010/06/02

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Basic information
Public title The exploratory study for the efficacy and the safety of rikkunshito on symptoms of upper gastrointestinal tract in the patients with gastroesophageal reflux disease (GERD)
Acronym The exploratory study for the efficacy of rikkunshito in the GERD patients
Scientific Title The exploratory study for the efficacy and the safety of rikkunshito on symptoms of upper gastrointestinal tract in the patients with gastroesophageal reflux disease (GERD)
Scientific Title:Acronym The exploratory study for the efficacy of rikkunshito in the GERD patients
Region
Japan

Condition
Condition GERD patients
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate efficacy and safety of rikkunshito on symptoms and esophageal motility in GERD patients
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Improvement of upper gastrointestinal symptoms in GERD patients
Key secondary outcomes 1)Improvement of function of esophageal motility
2)Safety of rikkunshito

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Oral administration of rikkunshito
(2.5g t.i.d) before meals for 56 days
Interventions/Control_2
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
20 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria Selection criterion at enrollment
1) Patients who were diagnosed as having GERD according to endoscopic testing and the score (4 points or more) obtained on the questionnaire for the diagnosis of reflux disease (QUEST)
2) Patients with the upper gastrointestinal symptoms such as abdominal pain or dyspepsia
3) Patients who have signed consent to participate in this research
Key exclusion criteria 1) Patients with severe cardiac failure, acute inflammatory disease or other severe complications
2) Patients who are pregnant, considering pregnancy or lactation
3) Patients with serious disorder in liver, gallbladder, or pancreas
4) Patients with gastrectomy
5) Patients who are intolerant to oral administration
6) Patients who received drugs prohibited for concomitant use during the observation period
7) Patients during treatment by traditional Japanese medicines
8) Patients considered inappropriate by the study investigator
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toru Sato
Organization Chiba University Hospital
Division name Department of Endoscopic Diagnostics and Therapeutics
Zip code
Address 1-8-1 Inohana, Chuou-ku, Chiba-shi, CHIBA
TEL 043-226-2329
Email

Public contact
Name of contact person
1st name
Middle name
Last name Toru Sato
Organization Chiba University Hospital
Division name Department of Endoscopic Diagnostics and Therapeutics
Zip code
Address 1-8-1 Inohana, Chuou-ku, Chiba-shi, CHIBA
TEL 043-226-2329
Homepage URL
Email

Sponsor
Institute Chiba University Hospital
Institute
Department

Funding Source
Organization TSUMURA & CO.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
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 千葉大学医学部附属病院(千葉県)

Other administrative information
Date of disclosure of the study information
2010 Year 01 Month 26 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 Completed
Date of protocol fixation
2007 Year 06 Month 20 Day
Date of IRB
Anticipated trial start date
2008 Year 04 Month 01 Day
Last follow-up date
2010 Year 03 Month 01 Day
Date of closure to data entry
2010 Year 06 Month 01 Day
Date trial data considered complete
2010 Year 08 Month 01 Day
Date analysis concluded
2010 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2010 Year 01 Month 26 Day
Last modified on
2010 Year 06 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003734

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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