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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004401
Receipt No. 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

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

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
URL(English) https://upload.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


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