UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032238 |
|---|---|
| Receipt number | 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 | 2023/10/16 09:37:38 |
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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. The number of tablets can be reduced to one tablet after meal two times a day (2 tablets/day) based on the age, body weight, or underlying condition.
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 | HAYAKAZU |
| Middle name | |
| Last name | SUMIDA |
Organization
The University of Tokyo Hospital
Division name
Dermatology
Zip code
113-8655
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655 JAPAN
TEL
0358008661
sumidah-der@h.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | HAYAKAZU |
| Middle name | |
| Last name | SUMIDA |
Organization
The University of Tokyo Hospital
Division name
Dermatology
Zip code
113-8655
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655 JAPAN
TEL
0358008661
Homepage URL
sumidah-der@h.u-tokyo.ac.jp
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
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
Graduate School of Medicine and Faculty of Medicine, Research Ethics Committee
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655 JAPAN
Tel
+81-3-3815-5411
ethics@m.u-tokyo.ac.jp
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
| 2019 | Year | 02 | Month | 17 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 13 | Day |
Last follow-up date
| 2026 | Year | 05 | Month | 21 | Day |
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
| 2023 | Year | 10 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036757
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