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

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05933486

Enrollment

150

Registered

2023-07-06

Start date

2023-09-30

Completion date

2024-09-30

Last updated

2023-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fibromyalgia Syndrome

Keywords

Tongluo-Kaibi Tablet, Traditional Chinese Medicine, Fibromyalgia Syndrome

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.

Interventions

DRUGTongluo-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.

DRUGplacebo 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
VAS	8 weeks	Visual Analogue Score

Secondary

Measure	Time frame	Description
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

Contacts

Primary ContactQuan Jiang

doctorjq@126.com+8613901081632

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026