UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013879 |
|---|---|
| Receipt number | R000016133 |
| Scientific Title | Clinical evaluation of Mashiningan and Daiokanzoto for the relief of constipation in Parkinson's disease |
| Date of disclosure of the study information | 2014/06/01 |
| Last modified on | 2019/06/22 11:59:59 |
* 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
Public title
Clinical evaluation of Mashiningan and Daiokanzoto for the relief of constipation in Parkinson's disease
Acronym
Comparative study of Mashiningan and Daiokanzoto
Scientific Title
Clinical evaluation of Mashiningan and Daiokanzoto for the relief of constipation in Parkinson's disease
Scientific Title:Acronym
Comparative study of Mashiningan and Daiokanzoto
Region
| Japan |
Condition
Condition
Constipation of Parkinson's disease patients
Classification by specialty
| Hepato-biliary-pancreatic medicine | Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To demonstrate the equivalence of efficacy in terms of improvement of constipation of Mashiningan and Daiokanzoto in Parkinson's disease patients with constipation symptoms that are resistant to treatment with Western medicine laxatives
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Constipation assessment scale
Key secondary outcomes
1) Bristol stool scale
2) Presence or absence of adverse effects
3) Other individual outcomes, obtained from responses to the questionnaire(Abdominal bloating, stool frequency, sensation of incomplete evacuation, straining, etc.)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Administration of Mashiningan for 4 weeks
Interventions/Control_2
Administration of Daiokanzoto for 4 weeks
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Parkinson's disease patients who satisfy all of the following conditions:
1) Adult male or female patients age 20 or older
2) Patients presenting with symptoms of constipation despite treatment with Western medicine laxatives
3) Patients with <=3 defecation/week, which has lasted for 6 months or longer
4) Patients who complain of one or more of the following symptoms which has lasted for 6 months or longer
･Lumpy or hard stools in >=1 out of 4 defecation
･Sensation of incomplete evacuation in >=1 out of 4 defecations
･Straining in >=1 out of 4 defecations
5) Patients willing and able to answer the self-administered questionnaire
6) Written informed consent from patients who are able to read and understand the consent document
Key exclusion criteria
1) Pregnant women or nursing mothers
2) Patients with apparent obstructions (such as tumors or hernias) in the intestinal tract
3) Patients with drug-induced constipation
4) Patients with known megacolon/megarectum or intestinal pseudo-obstruction
5) Patients who have undergone prior gastrointestinal surgery or abdominal surgery during the 3 months prior to the start of the study
6) Patients with significant cardiac, hepatic, pulmonary, renal, or mental diseases
7) Patients with severe clinical findings or abnormal laboratory (hematology/urinalysis) findings
8) Patients with uncontrolled hypertension, hyperaldosteronism, hypokalemia, or myopathy
9) Patients who may not comply with this research study protocol
10) Patients diagnosed with cancer within 5 years from the start of the study (except for carcinoma in situ)
11) Patients with constipation that is controlled through treatment with Mashiningan or Daiokanzoto prior to the start of this study
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shin-ichi Muramatsu |
Organization
Jichi Medical University
Division name
Oriental Medicine
Zip code
Address
3311-1 Yakushiji, Shimotsuke, Tochigi, Japan
TEL
0285-44-2111
muramats@jichi.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shin-ichi Muramatsu |
Organization
Jichi Medical University
Division name
Oriental Medicine
Zip code
Address
3311-1 Yakushiji, Shimotsuke, Tochigi, Japan
TEL
0285-44-2111
Homepage URL
muramats@jichi.ac.jp
Sponsor or person
Institute
Division of Oriental Medicine
Center for Community Medicine
Jichi Medical University
Institute
Department
Personal name
Funding Source
Organization
Division of Oriental Medicine
Center for Community Medicine
Jichi Medical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 06 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2014 | Year | 03 | Month | 25 | Day |
Date of IRB
| 2014 | Year | 03 | Month | 17 | Day |
Anticipated trial start date
| 2014 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 20 | Day |
Date of closure to data entry
| 2018 | Year | 03 | Month | 20 | Day |
Date trial data considered complete
| 2018 | Year | 03 | Month | 20 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 05 | Month | 02 | Day |
Last modified on
| 2019 | Year | 06 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016133
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
