MedTrace Logo

Study on the Efficacy and Safety of Tongluo Kaibi Tablets in the Treatment of Fibromyalgia Syndrome

NCT07708948 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2026-07-17

No results posted yet for this study

Summary

Fibromyalgia is a chronic, disabling musculoskeletal pain disorder. Pregabalin is the sole pharmaceutical agent approved for the treatment of fibromyalgia in China. Tongluo Kaibi Tablet, an approved proprietary Chinese medicine with collaterals-dredging and blood-activating effects, has demonstrated potential therapeutic benefits for fibromyalgia in preliminary small-scale observational studies, yet high-quality large-sample clinical evidence remains lacking. This multicenter, randomized, double-blind, double-dummy parallel-controlled clinical trial was conducted to evaluate the clinical efficacy and safety of Tongluo Kaibi Tablet in patients with fibromyalgia syndrome.

Conditions

  • Fibromyalgia Syndrome

Interventions

DRUG

Tongluo Kaibi Tablet

Tongluo Kaibi Tablet is composed of eight Chinese herbal medicines: Nux Vomica Powder, Radix Cyathulae, Radix Angelicae Sinensis, Flos Carthami, Fructus Chaenomelis, Herba Schizonepetae, Radix Saposhnikoviae and Scorpio. It dispels wind and unblocks collaterals, activates blood circulation and dissipates stagnation. It is indicated for joint pain and swelling caused by intermingled cold-heat complicated with blood stasis obstructing collaterals. Since its launch, it has been widely used in the treatment of rheumatic diseases.

DRUG

Pregabalin capsule

Pregabalin is one of the three medications (pregabalin, duloxetine, and milnacipran) that have been approved by the Food and Drug Administration (FDA) to treat fibromyalgia in US, and the only medicine that has been approved in China.

Sponsors & Collaborators

  • Guang'anmen Hospital of China Academy of Chinese Medical Sciences

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2024-01-01
Primary Completion
2025-10-31
Completion
2026-03-01

Countries

  • China

Study Locations

More Related Trials

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 NCT07708948 on ClinicalTrials.gov