Cepharanthine trial

JRCT ID: jRCTs061180072

Registered date:19/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: SjS
• Date of first enrollment: 11/08/2011
• Target sample size: 25
• Study type: Interventional
• Intervention(s): Cepharanthine (6 mg / day) administration

Outcome(s)

• Primary Outcome: 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

(2) Improvement of CRP value.
And in the histopathology (3) Improvement of lymphocyte infiltration, (4) Improvement of acinar structural destruction.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both
• Include criteria: Outpatient 20 years or older who meets the diagnostic criteria of Sjogren's syndrome

Exclude 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

Related Information

• Primary Sponsor: Yamanoi Tomoko