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

Phase 4

Not yet recruiting

• Conditions: Fibromyalgia Syndrome
• Interventions: Drug: Tongluo-Kaibi tablet plus placebo of pregabalin; Drug: placebo of Tongluo-Kaibi tablet plus pregabalin

• Registration Number: NCT05933486
• Lead Sponsor: Quan Jiang

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-06
• Study First Submitted: 2023-06-28
• Study First Submitted QC: 2023-06-28
• Last Update Submitted: 2023-06-28
• Study First Posted: 2023-07-06
• Last Update Posted: 2023-07-06
• Study Start: 2023-09
• Primary Completion: 2023-11
• Study Completion: 2024-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tongluo-Kaibi tablet plus placebo of pregabalin	Tongluo-Kaibi tablet plus placebo of pregabalin	-
placebo of Tongluo-Kaibi tablet plus pregabalin	placebo of Tongluo-Kaibi tablet plus pregabalin	-

Primary Outcome Measures

Name	Time	Method
VAS	8 weeks	Visual Analogue Score

Secondary Outcome Measures

Name	Time	Method
MFI-20	8 weeks	Multidimensional Fatigue Inventory
PSQI	8 weeks	Pittsburgh Sleep Quality Index
BDI	8 weeks	Beck Depression Inventory
WPI	8 weeks	Widespread Pain Index