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

Quan Jiang0 sites150 target enrollmentSeptember 2023

ConditionsFibromyalgia Syndrome

InterventionsTongluo-Kaibi tablet plus placebo of pregabalin placebo of Tongluo-Kaibi tablet plus pregabalin

DrugsTongluo-Kaibi tablet plus placebo of pregabalin placebo of Tongluo-Kaibi tablet plus pregabalin

Overview

Phase: Phase 4
Intervention: Tongluo-Kaibi tablet plus placebo of pregabalin
Conditions: Fibromyalgia Syndrome
Sponsor: Quan Jiang
Enrollment: 150
Primary Endpoint: VAS
Status: Not yet recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

September 2023

End Date

September 2024

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Quan Jiang

Responsible Party

Sponsor Investigator

Principal Investigator

Quan Jiang

chief physician

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Eligibility Criteria

Inclusion Criteria

•Those who meet the classification criteria for Fibromyalgia formulated by the American Rheumatology Association in
•Pain VAS score ≥ 4 points.
•The variety and dosage of the medication used to treat the disease should be stable for at least 2 weeks.

Exclusion Criteria

•Severe cardiovascular and cerebrovascular diseases.
•Malignant tumors, hematological diseases, inflammatory arthritis, or other serious or progressive systemic diseases.
•ALT and AST are more than 2 times the upper limit of normal.
•Cr is more than 1.2 times the upper limit of normal.
•Allergic constitution or allergic to experimental drugs Tongluo-Kaibi tablet, pregabalin capsules, excipients or similar ingredients.
•Pregnant, lactating or recently planned pregnancy.