Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2025-12-25 @ 12:00 AM
NCT ID:
NCT02855658
Eligibility Criteria:
Inclusion Criteria:
* Primary or Secondary Sjögren's syndrome patient
* Age from 20 to 75 year old, male or female patient
* Fit the criteria of 2002 year American-European classification
* If the subject took Cyclosporine, Cevimeline, Pilocarpine, Rituximab or other biological agent before enter into our study, the subject need to stop these drugs for one month
* If the subject took Gan-Lu-Yin, Sang- Ju-Yin or Xuefu-Zhuyu-Decoction before enter into our study, the subject need to stop these drugs for one month
* Secondary Sjögren's syndrome patient:
* Stable treatment: Steroid (≦10mg/d) and fixed hydroxychloroquine dose before 3 months enrolled
* No abnormal change of immunology, liver, kidney, and blood function
* No major life threatened condition
Exclusion Criteria:
* Alcohol abuse, DM (Glucose PC\>200mg/dL) and major life threatened condition
* Pregnancy or breast feeding
* Abnormal liver and kidney function
* Forbid steroid pulse therapy before 3 months enrolled into our study, and forbid the Chinese herbal medicine except SS-1
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
75 Years
Study:
NCT02855658
Study Brief:
Protocol Section:
NCT02855658