UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003092 |
|---|---|
| Receipt number | 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 16:40:51 |
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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
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
Sponsor or person
Institute
Chiba University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003734
