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

Quan Jiang150 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

150

Conditions

Fibromyalgia Syndrome

Interventions

Tongluo-Kaibi tablet plus placebo of pregabalinDRUG

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.

placebo of Tongluo-Kaibi tablet plus pregabalinDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

VAS

Visual Analogue Score

Time frame: 8 weeks

Secondary Outcomes

MFI-20

Multidimensional Fatigue Inventory

Time frame: 8 weeks

BDI

Beck Depression Inventory

Time frame: 8 weeks

PSQI

Pittsburgh Sleep Quality Index

Time frame: 8 weeks

WPI

Widespread Pain Index

Time frame: 8 weeks

Central Contacts

Quan Jiang

CONTACT

+8613901081632 doctorjq@126.com

Data from ClinicalTrials.gov

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