UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004401
Receipt number R000005260
Scientific Title A Single Centre Prospective Randomized Double Blinded Trial to Assess the Efficiency of A Chinese Herbal-medicine (Xilei San) Suppository for Active Ulcerative Proctitis
Date of disclosure of the study information 2010/10/18
Last modified on 2013/04/15 09:19:52

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Basic information

Public title

A Single Centre Prospective Randomized Double Blinded Trial to Assess the Efficiency of A Chinese Herbal-medicine (Xilei San) Suppository for Active Ulcerative Proctitis

Acronym

Efficiency of Chinese Herbal-suppository for Active Ulcerative Proctitis

Scientific Title

A Single Centre Prospective Randomized Double Blinded Trial to Assess the Efficiency of A Chinese Herbal-medicine (Xilei San) Suppository for Active Ulcerative Proctitis

Scientific Title:Acronym

Efficiency of Chinese Herbal-suppository for Active Ulcerative Proctitis

Region

Japan


Condition

Condition

Ulcerative colitis (Proctitis type)

Classification by specialty

Medicine in general Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

In order to evaluate efficacy and safety of a newly developed suppository medicine containing a Chinese herbal-medicine (Xilei San) for active ulcerative proctitis patients refracting current other medication(s) because of adverse event and/or ineffectiveness.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II,III


Assessment

Primary outcomes

Remission rate at 24 weeks after the start of protocol treatment
(Full Analysis Set; Discontinuation of protocol treatment is accounted to be non-remission.)

Key secondary outcomes

Evaluation of efficiency: Remission ratios at 48 weeks after start of protocol treatment, Ratio of the protocol continuation, Clinical activity in both the Rachmilewitz clinical activity index (CAI) and Endoscopic index (EI), Liley histological score, and evaluation of patients QOL using IBDQ, etc.
Evaluation of safety: Adverse event, Abnormal values in blood test, etc.


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Placebo arm:
A sham suppository containing 0.1g of medical carbon during the study period (for 48 weeks).

Interventions/Control_2

True arm:
A suppository containing 0.1g of Herbal-medicine (Xilei San) during the study period

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

16 years-old <=

Age-upper limit

75 years-old >=

Gender

Male and Female

Key inclusion criteria

1. A patient who is diagnosed as ulcerative colitis.
2. A patient who has been diagnosed as active UC with disease extension of within 15cm from anus by either endoscopic or roentgenogram examination within 4 weeks.
3. A patient who refracted more than 4 weeks of conventional topical therapy prior to enroll the trial.
4. A patient who is expected to suffer from severe adverse effect of the conventional therapy, i.e. 5-ASA and/or steroid, by reason of his (her) past history or other. (judged by a doctor in charge)
5. A patient who is 16 to 64 years old and has written his (her) signature to a document for agreement. (If a patient is under 20 years old, a signature of his (her) legal representative is necessary.)

Key exclusion criteria

1. A patient who has had hypersensitivity to Chinese medicine.
2. A patient who has had an episode of severe hypersensitivity to food.
3. A patient who has complicated severe heart, kidney, respiratory, and metabolic disease.
4. A patient, who is pregnant, may be pregnant, breast-feeds or hopes to be pregnant in the study period.
5. A patient who is determined as ineligible for a subject in this study by a doctor in charge or others.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takayuki Matsumoto

Organization

Hyogo College of Medicine

Division name

Lower GI disease

Zip code


Address

1

TEL

0798-45-6660

Email



Public contact

Name of contact person

1st name
Middle name
Last name Ken Fukunaga

Organization

Hyogo College of Medicine

Division name

Lower GI disease

Zip code


Address

1-1 Mukogawa, Nishinomiya, Hyogo Pref.

TEL

0798-45-6662

Homepage URL


Email

kebe@hyo-med.ac.jp


Sponsor or person

Institute

Hyogo College of Medicine, Department of Internal medicine, Division of Lower GI disease

Institute

Department

Personal name



Funding Source

Organization

Hyogo College of Medicine, Department of Internal medicine, Division of Lower GI disease

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

2010 Year 10 Month 18 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

http://www.ncbi.nlm.nih.gov/pubmed/22775479

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 05 Month 08 Day

Date of IRB


Anticipated trial start date

2007 Year 06 Month 01 Day

Last follow-up date

2010 Year 11 Month 01 Day

Date of closure to data entry

2010 Year 12 Month 01 Day

Date trial data considered complete

2010 Year 12 Month 01 Day

Date analysis concluded

2010 Year 12 Month 01 Day


Other

Other related information



Management information

Registered date

2010 Year 10 Month 18 Day

Last modified on

2013 Year 04 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005260


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name