Cepharanthine trial

Phase 2

• Conditions: SjS

• Registration Number: JPRN-jRCTs061180072
• Lead Sponsor: Yamanoi Tomoko

Brief Summary

This study suggests that cepharanthine may be effective in salivary glamd symptoms in patients with Sjogren's syndrome.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-19
• Study Completion: 2020-07-30
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

Outpatient 20 years or older who meets the diagnostic criteria of Sjogren's syndrome

Exclusion Criteria

1. History of hypersensitivity to cepharanthine
2. Serious ischemic heart disease
3. Bronchial asthma and chronic obstructive pulmonary disease
4. Blockade of gastrointestinal tract and bladder neck
5. Epilepsy
6. Parkinsonism or Parkinson's disease
7. Patients with iritis
8. Pregnant women, lactating women or possible pregnancy
9. Others inappropriate

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate (1) salivary secretion improvement after taking cepharanthine (6 mg / day) compared with the first time in patients with Sjogren's syndrome.

Secondary Outcome Measures

Name	Time	Method
(2) Improvement of CRP value.<br>And in the histopathology (3) Improvement of lymphocyte infiltration, (4) Improvement of acinar structural destruction.