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

Sponsor

Quan Jiang (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05933486

Collaborator

(none)

150

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Fibromyalgia Syndrome	Drug: Tongluo-Kaibi tablet plus placebo of pregabalin Drug: placebo of Tongluo-Kaibi tablet plus pregabalin	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Nov 1, 2023

Anticipated Study Completion Date :

Sep 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Tongluo-Kaibi tablet plus placebo of pregabalin	Drug: Tongluo-Kaibi tablet plus placebo of pregabalin 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.
Active Comparator: placebo of Tongluo-Kaibi tablet plus pregabalin	Drug: placebo of Tongluo-Kaibi tablet plus pregabalin 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.

Arm

Intervention/Treatment

Experimental: Tongluo-Kaibi tablet plus placebo of pregabalin

Drug: Tongluo-Kaibi tablet plus placebo of pregabalin

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.

Active Comparator: placebo of Tongluo-Kaibi tablet plus pregabalin

Drug: placebo of Tongluo-Kaibi tablet plus pregabalin

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.

Outcome Measures

Primary Outcome Measures

VAS [8 weeks]
Visual Analogue Score

Secondary Outcome Measures

MFI-20 [8 weeks]
Multidimensional Fatigue Inventory
BDI [8 weeks]
Beck Depression Inventory
PSQI [8 weeks]
Pittsburgh Sleep Quality Index
WPI [8 weeks]
Widespread Pain Index

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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.