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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032238
Receipt No. R000036757
Scientific Title Exploratory Clinical Study on the Effectiveness of Glycyrrhizin in Early Vascular Lesions of Systemic Sclerosis
Date of disclosure of the study information 2018/04/13
Last modified on 2018/04/13

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Basic information
Public title Exploratory Clinical Study on the Effectiveness of Glycyrrhizin in Early Vascular Lesions of Systemic Sclerosis
Acronym The Effectiveness of Glycyrrhizin in Systemic Sclerosis
Scientific Title Exploratory Clinical Study on the Effectiveness of Glycyrrhizin in Early Vascular Lesions of Systemic Sclerosis
Scientific Title:Acronym The Effectiveness of Glycyrrhizin in Systemic Sclerosis
Region
Japan

Condition
Condition Systemic Sclerosis
Classification by specialty
Clinical immunology Dermatology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate efficacy of Glycyrrhizin in early vascular lesions of systemic sclerosis
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I,II

Assessment
Primary outcomes Number of capillary vessels per unit length of posterior fingernail counted every 4 weeks from the start of administration
Key secondary outcomes every 4 weeks from the start of administration

1.Number of enlarged or disarrangement capillary vessels or avascular areas per unit length of posterior fingernail counted every 4 weeks from the start of administration
2.Raynaud score
3.Health Assessment Questionnaire score
4.modified Rodnan total skin thickness score
5.Presence or absence of new ulcer on finger


Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Take three tablets after meal three times a day (9 tablets/day) for 24 weeks.
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

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria 1)systemic sclerosis patients (Ministry of Health, Labor and Welfare Japan, diagnostic criteria 2016)
2)Patients whose age ranges from 20 years to under 80 when acquiring consent
3)After receiving sufficient explanation for the participation of this study, patients who obtained document consent by the patient's free will with sufficient understanding
Key exclusion criteria 1)Patients with aldosteronism, myopathy or hypokalemia
2)Patients with cirrhosis with more than 70 microgram/dL serum ammonia concentration
3)Patients less than 3 months after the final administration of the other test drugs or investigational drugs
4)Patients with more than 10 MRSS (modified Rodnan total skin thickness score)
5)Patients with not satisfy% VC 80% and % DLCO 70% in respiratory function test
6)Patients with eGFR less than 45 mL / min / 1.73 m2
7)Patients with more than RVSP>40mmHg pulmonary hypertension
8)Patients with complications of systemic lupus erythematosus or dermatomyositis
9)Patients with a history of malignant tumors
10)Patients with a history of severe hypersensitivity or anaphylactic reaction to the components of test drug
11)patient judged by doctor as inappropriate
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hayakazu Sumida
Organization The University of Tokyo Hospital
Division name Dermatology
Zip code
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655 JAPAN
TEL +81-3-3815-5411
Email sumidah-der@h.u-tokyo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hayakazu Sumida
Organization The University of Tokyo Hospital
Division name Dermatology
Zip code
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655 JAPAN
TEL +81-3-3815-5411
Homepage URL
Email sumidah-der@h.u-tokyo.ac.jp

Sponsor
Institute The University of Tokyo
Institute
Department

Funding Source
Organization The University of Tokyo
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
2018 Year 04 Month 13 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 Open public recruiting
Date of protocol fixation
2018 Year 04 Month 13 Day
Date of IRB
Anticipated trial start date
2018 Year 04 Month 13 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
2018 Year 04 Month 13 Day
Last modified on
2018 Year 04 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036757

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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