A Multicenter, Randomized, Double-Blind Study on the Efficacy and Safety of Tongluo Kaibi Tablets in the Treatment of Fibromyalgia Syndrome
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- The change of the Visual Analogue Scale (VAS) for pain from baseline.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Tongluo Kaibi Tablet group
Tongluo Kaibi Tablets, 0.9 g per dose, once daily; pregabalin matching placebo, 150 mg per dose, once daily. After one week, the dose of pregabalin matching placebo will be titrated up to 150 mg twice daily if tolerated by patients. For patients with poor tolerance, the dosage shall remain 150 mg once daily for a total treatment period of 8 weeks.
干预措施: Tongluo Kaibi Tablet (Drug)
结局指标
主要结局
The change of the Visual Analogue Scale (VAS) for pain from baseline.
时间窗: Baseline, week 4, and week 8
Pain VAS, range, 0 to 100 mm, where higher scores indicated the perceived pain to be more severe.
次要结局
- The change of the revised Fibromyalgia Impact Questionnaire (FIQR) from baseline.(Baseline, week 4, and week 8.)
- The change of the Multidimensional Fatigue Inventory-20 (MFI-20) from baseline.(Baseline, week 4, and week 8.)
- The change of the Pittsburgh Sleep Quality Index (PSQI) from baseline.(Baseline, week 4, and week 8.)
- The Beck II Depression Inventory (BDI)(Baseline, week 4, and week 8.)
- The change of the revised Widespread Pain Index(WPI)from baseline.(Baseline, week 4, and week 8.)
研究者
Juan Jiao
chief physician
Guang'anmen Hospital of China Academy of Chinese Medical Sciences