A Randomized, Double-blind, Placebo-controlled, Multi-center Clinical Study of Saussurea Involucrata Liquid Tonic in the Treatment of Postpartum Rheumatism
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 128
- 主要终点
- VAS (visual analog scale)
研究概览
简要总结
This study is a multi-center, randomized, double-blinded, controlled trial with two parallel arms. The study aims to evaluate the efficacy and safety of Involucrata Liquid Tonic in patients with Postpartum Rheumatism.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women experience joint and muscle pain, soreness, heaviness, numbness, etc. within 1 year after childbirth, miscarriage or induction of labor; with or without sensitivity to external stimuli such as wind, cold, moisture, etc., which may be induced or aggravated by emotional fluctuations
- •Meets the diagnostic criteria for Yang Qi deficiency and cold-dampness syndrome.
- •Age 18-50
- •Pain VAS score ≥4cm
排除标准
- •Those in the puerperium (within 42 days after delivery).
- •Those who have rheumatoid arthritis, ankylosing spondylitis, osteitis density, polymyalgia rheumatica, reactive arthritis, myofasciitis, fibromyalgia syndrome and other rheumatic immune diseases before pregnancy.
- •Severe abnormalities in blood routine and electrocardiogram, active liver disease or abnormal liver function, AST, ALT or GGT higher than 1.2 times the upper limit of normal value; abnormal renal function, serum creatinine (sCr) higher than 1.2 times the upper limit of normal value. Patients whose white blood cell count < 3.0×109/L, or hemoglobin < 90 g/L, or platelet count < 100.0×109/L in routine blood examination
- •Combined with serious underlying diseases, primary diseases and postpartum diseases, such as uncontrollable hypertension, heart disease, kidney disease, puerperal fever, mastitis, moderate to severe postpartum depression diagnosed by a psychiatric department, etc.
- •Those who have a history of using glucocorticoids, immunosuppressants and other drugs within 4 weeks.
- •Those who are allergic to the ingredients of the test drug or have a high-sensitivity constitution.
- •Existing or past history of cancer.
- •Those who have participated in other clinical drug studies in the past 2 months.
- •Those who do not use the medication as prescribed, or who have incomplete information that affects the judgment of efficacy.
研究组 & 干预措施
Saussurea Involucrata Liquid Tonic
Saussurea Involucrata Liquid Tonic 20ml/time, 2 times a day, orally on an empty stomach. Total treatments 8 weeks, followed up to 12 weeks.
干预措施: Saussurea Involucrata Liquid Tonic (Drug)
placebo of Saussurea Involucrata Liquid Tonic
placebo of Saussurea Involucrata Liquid Tonic 20ml/time, 2 times a day, orally on an empty stomach. Total treatments 8 weeks, followed up to 12 weeks.
干预措施: Saussurea Involucrata Liquid Tonic (Drug)
结局指标
主要结局
VAS (visual analog scale)
时间窗: 8 weeks
The number of cases with pain VAS (visual analog scale) improvement ≥30%/number of enrolled cases × 100%.
次要结局
- SF-36(8 weeks)
- HADS(8 weeks)
- HAQ(8 weeks)
- VAS(8 weeks)
研究者
Quan Jiang
chief physician
Guang'anmen Hospital of China Academy of Chinese Medical Sciences