The Effectiveness of Glycyrrhizin in Systemic Sclerosis

Not Applicable

Recruiting

• Conditions: Systemic sclerosis

• Registration Number: JPRN-jRCTs031180366
• Lead Sponsor: Sumida Hayakazu

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-18
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 20

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
11)patient judged by doctor as inappropriate

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
umber of capillary vessels per unit length of posterior fingernail counted by using dermoscopy from the start of administration

Secondary Outcome Measures

Name	Time	Method
1.Number of enlarged or disarrangement capillary vessels or avascular areas per unit length of posterior fingernail counted by using dermoscopy from the start of administration <br>2.Raynaud score <br>3.Health Assessment Questionnaire score <br>4.modified Rodnan total skin thickness score <br>5.Presence or absence of new ulcer on finger