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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000013879
Receipt No. 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

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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
Email 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
Email muramats@jichi.ac.jp

Sponsor
Institute Division of Oriental Medicine
Center for Community Medicine
Jichi Medical University
Institute
Department

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
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

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
URL(English) https://upload.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


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