Clinical Trial

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

Completed Phase 4
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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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-07-13.
Trial Details
NCT Number NCT07708948
Lead Sponsor Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Conditions Fibromyalgia Syndrome
Enrollment 150 participants
Start Date 2024-01-01
Primary Completion 2025-10-31 (estimated)
Study Completion 2026-03-01 (estimated)
Updated on ClinicalTrials.gov 2026-07-17