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Recruitment status Main results already published
Unique ID issued by UMIN UMIN000007393
Receipt No. R000008711
Scientific Title The effects of Daikenchuto for the tretment of constipation in the patients with cerebrovascular diseases
Date of disclosure of the study information 2012/05/01
Last modified on 2020/08/04

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Basic information
Public title The effects of Daikenchuto for the tretment of constipation in the patients with cerebrovascular diseases
Acronym Daikenchuto improve constipation in the patients with cerebrovascular diseases
Scientific Title The effects of Daikenchuto for the tretment of constipation in the patients with cerebrovascular diseases
Scientific Title:Acronym Daikenchuto improve constipation in the patients with cerebrovascular diseases
Region
Japan

Condition
Condition cerebrovascular diseases with constipation
Classification by specialty
Medicine in general Gastroenterology Cardiology
Neurology Geriatrics Vascular surgery
Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effects of Daikenchuto to treat constipation in the patients with cerebrovascular diseases
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Improvement of clinical score of constipation
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Randomized
Randomization unit
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Tsumura Daikenchuto 15g/day
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
110 years-old >
Gender Male and Female
Key inclusion criteria Cerebrovasucular diseases
Constipation evaluated by RomaIII
Constipation over 6 months and usage of anticonstipation drugs
Key exclusion criteria Patients with malignancy
Patients with severe liver, heart, and renal diseases
Loss of consciousness
Patients who have already treated by Daikenchuto
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takayama
Organization Tohoku University
Division name Department of traditional Asian medicine
Zip code
Address 2-1, Seiryo-machi, Aoba-ku, Sendai city, Japan
TEL 022-717-7507
Email takayama@med.tohoku.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kuwabara
Organization Tohoku University Hospital
Division name Comprehensive Regional Medical Education Support Department, Kampo Internal Medicine
Zip code
Address 1-1, Seiryo-machi, Aoba-ku, Sendai city, Japan
TEL 022-717-7507
Homepage URL
Email akiko.kuwabara.d7@tohoku.ac.jp

Sponsor
Institute Tohoku University
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization Grant-in-Aid for Scientific Research (C)
Organization
Division
Category of Funding Organization Japanese Governmental office
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
2012 Year 05 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.hindawi.com/journals/ecam/2014/231258/
Number of participants that the trial has enrolled
Results Poststroke patients with functional constipation, assessed by the Rome III criteria, from 6 hospitals were recruited in a study on the effects of the traditional Japanese medicine Daikenchuto (DKT) on constipation. Thirty-four patients (17 men and 17 women; mean age: 78.1 years) were randomly assigned to 2 groups; all patients received conventional therapy for constipation, and patients in the DKT group received 15g/day of DKT for 4 weeks. Constipation scoring system (CSS) points and the gas volume score (GVS) (the measure of the intestinal gas volume calculated from plain abdominal radiographs) were recorded before and after a 4-week observation period. The total score on the CSS improved significantly in the DKT group compared to the control (p < 0.01 ). In addition, scores for some CSS subcategories (frequency of bowel movements, feeling of incomplete evacuation, and need for enema/disimpaction) significantly improved in the DKT group (p < 0.01, p = 0.049, and p = 0.03, resp.). The GVS was also significantly reduced in the DKT group compared to the control ( p = 0.03). DKT in addition to conventional therapy is effective in treating functional constipation in poststroke patients.
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 Main results already published
Date of protocol fixation
2012 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 04 Month 01 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
2012 Year 02 Month 28 Day
Last modified on
2020 Year 08 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008711


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