drugset / Trial / NCT03755258

Trial of Ginsenoside Compound K (GCK) Tablet in Patients With Rheumatoid Arthritis

NCT03755258 ↗

Phase 1 Unknown 128 enrolled Zhejiang Hisun Pharmaceutical Co. Ltd.
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

EvaluationDrugModalityDoseRoute
Subject Ginsenoside Compound K Unknown 100 mg Oral
Subject Ginsenoside Compound K Unknown 200 mg Oral
Subject Ginsenoside Compound K Unknown 300 mg Oral

Indications