Clinical Research Directory

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.