NCT05933486

Efficacy and Safety of Tongluo-Kaibi Tablet in Patients With Fibromyalgia Syndrome

A Multicenter, Randomized, Double-blind Study on the Efficacy and Safety of Tongluo-Kaibi Tablet in the Treatment of Fibromyalgia Syndrome

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Quan Jiang · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is a multi-center, randomized, double-blinded, controlled trial with two parallel arms. The aim of the study is to evaluate efficacy and safety of Tongluo-Kaibi tablets in patients with Fibromyalgia Syndrome.

Conditions

• Fibromyalgia Syndrome

Interventions

Type	Name	Description
DRUG	Tongluo-Kaibi tablet plus placebo of pregabalin	Tongluo-Kaibi Tablet 0.93g qd； Placebo of pregabalin 150mg qd. If the patient can tolerate it, it will be increased to 150mg bid one week later. If the patient cannot tolerate it, it will be maintained at 150mg qd until the 8th week.
DRUG	placebo of Tongluo-Kaibi tablet plus pregabalin	placebo of Tongluo-Kaibi Tablet 0.93g qd； Pregabalin 150mg qd. If the patient can tolerate it, it will be increased to 150mg bid one week later. If the patient cannot tolerate it, it will be maintained at 150mg qd until the 8th week.

Timeline

• Start date: 2023-09-01
• Primary completion: 2023-11-01
• Completion: 2024-09-01
• First posted: 2023-07-06
• Last updated: 2023-07-06