JPRN-jRCTs031180366
Recruiting
未知
Exploratory Clinical Study on the Effectiveness of Glycyrrhizin in Early Vascular Lesions of Systemic Sclerosis
Sumida Hayakazu0 sites20 target enrollmentMarch 18, 2019
ConditionsSystemic sclerosis
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Systemic sclerosis
- Sponsor
- Sumida Hayakazu
- Enrollment
- 20
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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
Outcomes
Primary Outcomes
Not specified
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