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

Study 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.

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

Conditions
-----------------
Fibromyalgia Syndrome

Intervention / Treatment
-----------------
* Drug: Tongluo-Kaibi tablet plus placebo of pregabalin
* Drug: placebo of Tongluo-Kaibi tablet plus pregabalin


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tongluo-Kaibi tablet plus placebo of pregabalin<br> | Drug: Tongluo-Kaibi tablet plus placebo of pregabalin<br>* 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.<br>|
| Active Comparator: placebo of Tongluo-Kaibi tablet plus pregabalin<br> | Drug: placebo of Tongluo-Kaibi tablet plus pregabalin<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS | Visual Analogue Score | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MFI-20 | Multidimensional Fatigue Inventory | 8 weeks | 
| BDI | Beck Depression Inventory | 8 weeks | 
| PSQI | Pittsburgh Sleep Quality Index | 8 weeks | 
| WPI | Widespread Pain Index | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tongluo-Kaibi Tablet, Traditional Chinese Medicine, Fibromyalgia Syndrome