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

Quan Jiang

Status and phase: Not yet enrolling; Phase 4

Conditions: Fibromyalgia Syndrome

Treatments: Drug: Tongluo-Kaibi tablet plus placebo of pregabalin; Drug: placebo of Tongluo-Kaibi tablet plus pregabalin

Study type: Interventional

Funder types: Other

Identifiers

NCT05933486

2022013P7A02

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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150 participants in 2 patient groups

Tongluo-Kaibi tablet plus placebo of pregabalin

Experimental group

Treatment:

Drug: Tongluo-Kaibi tablet plus placebo of pregabalin

placebo of Tongluo-Kaibi tablet plus pregabalin

Active Comparator group

Treatment:

Drug: placebo of Tongluo-Kaibi tablet plus pregabalin