NCT03932019

Study of Jitongning Tablet to Treat Spondyloarthritis

A Randomized, Double-blind, Placebo-controled, Multi-center Phase II Clinical Trial for Evaluation of the Efficacy and Safety of Jitongning Tablet in Patients With Active Axial Spondyloarthritis(SpA)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 238 (actual)
• Sponsor: Tasly Pharmaceutical Group Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study is to investigate the efficacy and safety of Jitongning Tablet in improving joint function and pain symptoms in active axial spondyloarthritis (SpA) patients and to explore the optimal dosage.

Detailed description

Jitongning Tablet is a kind of traditional Chinese medicine(TCM), consists of Cortex Eucommiae, Duhuo(Radix Angelicae Pubescentis), Zhichuanwu(Radix Aconiti) , Rhizoma Corydalis, Radix Paeoniae Rubra, Radix Puerariae and Radix Glycyrrhizae. This study is being conducted to evaluate the efficacy and safety of Jitongning Tablet in patients with active axial spondyloarthritis (SpA) (Syndrome Of Kidney Yang Deficiency and Biood Stasis Stagnation), when compared with placebo and to explore the optimal dosage.

Conditions

• Spondyloarthritis

Interventions

Type	Name	Description
DRUG	Jitongning tablet(High-dose )	Jitongning tablet,3tablets,bid,treat 12 weeks
DRUG	Jitongning tablet(Low-dose )	Jitongning tablet,2tablets,bid,treat 12 weeks Jitongning tablet placebo,1tablet,bid,treat 12 weeks
DRUG	Placebo	Jitongning tablet placebo,3tablets,bid,treat 12 weeks

Timeline

• Start date: 2019-06-11
• Primary completion: 2021-06-20
• Completion: 2021-08-20
• First posted: 2019-04-30
• Last updated: 2022-11-21

Locations

11 sites across 1 country: China