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

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.

Inclusion Criteria:

• Those who meet the classification criteria for Fibromyalgia formulated by the American Rheumatology Association in 2016.
• 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.