UMIN-CTR Clinical Trial

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

cerebrovascular diseases with constipation

Classification by specialty

Medicine in general	Gastroenterology	Cardiology
Neurology	Geriatrics	Vascular surgery
Neurosurgery

Classification by malignancy

Others

Genomic information

NO

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

Primary outcomes

Improvement of clinical score of constipation

Key secondary outcomes

Study type

Interventional

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

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

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

Name of lead principal investigator

1st name	Shin
Middle name
Last name	Takayama

Organization

Tohoku University

Division name

Department of traditional Asian medicine

Zip code

9808574

Address

2-1, Seiryo-machi, Aoba-ku, Sendai city, Japan

TEL

022-717-7507

Email

takayama@med.tohoku.ac.jp

Name of contact person

1st name	Akiko
Middle name
Last name	Kuwabara

Organization

Tohoku University Hospital

Division name

Comprehensive Regional Medical Education Support Department, Kampo Internal Medicine

Zip code

9808574

Address

1-1, Seiryo-machi, Aoba-ku, Sendai city, Japan

TEL

022-717-7507

Homepage URL

Email

akiko.kuwabara.d7@tohoku.ac.jp

Institute

Tohoku University

Institute

Department

Personal name

Organization

Grant-in-Aid for Scientific Research (C)

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Ethics Committee Tohoku University Hospital

Address

1-1, Seiryo-machi, Aoba-ku, Sendai city

Tel

022-728-4105

Email

ec@rinri.hosp.tohoku.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2012

Year

05

Month

01

Day

URL releasing protocol

Publication of results

Published

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

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 related information

Registered date

2012

Year

02

Month

28

Day

Last modified on

2020

Year

08

Month

04

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008711