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

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

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.

Inclusion Criteria:

• Aged 18 to 75 years at the time of informed consent acquisition, regardless of gender;
• Meet the 2016 fibromyalgia classification criteria established by the American College of Rheumatology;
• Score ≥4 on the Visual Analogue Scale for Pain (Pain VAS) at screening;
• Agree to receive 8 weeks of treatment and related examinations, and sign the informed consent form;
• No medication for fibromyalgia, or the types and dosages of medications for fibromyalgia have remained stable for at least 2 weeks.

Exclusion Criteria:

• Have a medical history or confirmed diagnosis of any of the following conditions during screening: severe cardiovascular and cerebrovascular diseases; combined diabetes, malignant tumors, hematological diseases, inflammatory arthritis or other severe progressive systemic diseases; other psychiatric disorders leading to inability or unwillingness to cooperate with the trial;
• Any laboratory test result before screening meets the following criteria: liver and renal function tests show ALT or AST > 2 times the upper limit of normal (ULN), or creatinine (Cr) > 1.2 times ULN (refer to the normal reference range of the laboratory at each study center); other clinically significant abnormal laboratory parameters judged by investigators to disqualify subjects from enrollment;
• Allergic constitution, or hypersensitivity to the investigational product Tongluo Kaibi Tablets, pregabalin capsules, excipients or similar ingredients; Suspected or confirmed history of alcohol or substance abuse;
• Pregnant or lactating women, women planning pregnancy in the near future, or those unwilling to adopt contraceptive measures;
• Receiving Tongluo Kaibi Tablets at enrollment;
• Participation in any other clinical trial within 3 months prior to enrollment;
• Any other conditions judged by investigators to render the subject unsuitable for this clinical trial.