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

NCT05933486 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2023-07-06

No results posted yet for this study

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.

Conditions

  • Fibromyalgia Syndrome

Interventions

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.

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.

Sponsors & Collaborators

  • Quan Jiang

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-30
Primary Completion
2023-11-30
Completion
2024-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05933486 on ClinicalTrials.gov