drugset / Trial / NCT03755258
Trial of Ginsenoside Compound K (GCK) Tablet in Patients With Rheumatoid Arthritis
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This is a phase Ib study to investigate the safety, pharmacokinetics and preliminary efficacy of ginsenoside compound K (GCK) tablets in patients with rheumatoid arthritis. This study is to be run in China involving 10-12 sites. It will enroll approximately 240 patients to ensure 128 randomized with active rheumatoid arthritis. The treatment period is 12 weeks and total study duration per patient is approximately 14 weeks.
Timeline
- Start
- 2017-03-16
- Primary completion
- 2019-07-11
- Completion
- 2019-12-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ginsenoside Compound K | Unknown | 100 mg | Oral |
| Subject | Ginsenoside Compound K | Unknown | 200 mg | Oral |
| Subject | Ginsenoside Compound K | Unknown | 300 mg | Oral |