A Clinical Study of Tranilast in the Treatment of Sarcoidosis
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 56
- 主要终点
- Changes of the forced vital capacity(FVC)
研究概览
简要总结
56 patients with sarcoidosis will be selected to receive treatment of tranilast.The investigators can analyse the changes in the thickness and area of skin lesions before and after treatment as well as other involved organs nodule size changes to determine the efficacy and safety of drugs.
详细描述
56 patients with sarcoidosis will be selected. After the signing of the informed consent ,participants will be collected the initial lesions photos, the size of the lump by ultrasound, the forced vital capacity(FVC), and chemical examinations including blood routine examination, routine urine test, liver function, renal function. During tranilast treatment (0.1g each time, three times a day) , participants need regular follow-up (1 per month) including liver and kidney function, blood glucose level monitoring, every three months to retest ultrasound and the forced vital capacity(FVC). With 3 month as a time point, participants were observed for four points(one point if only skin invasion ).After the experiment, the experimental data will be arranged and the data will be statistically processed (t test) to determine whether it is meaningful.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(1)patients with diagnosed sarcoidosis, the skin pathology showed non necrotic granuloma and negative staining of fungi and atypical mycobacterium; (2)No corticosteroids and immunosuppressants were used for nearly 1 months.
排除标准
- •with a liver or kidney disease, or accompanied by a tumor or a severe infection ; (2)with mental disease.
研究组 & 干预措施
Tranilast
干预措施: Tranilast (Drug)
结局指标
主要结局
Changes of the forced vital capacity(FVC)
时间窗: 12 months
During tranilast (0.1g each time, three times a day,12 months) treatment, patients need to retest the forced vital capacity(FVC),then get the changes.
Changes in the size of the pulmonary nodule by ultrasound
时间窗: 12 months
During tranilast (0.1g each time, three times a day,12 months) treatment, patients need to retest the size of the pulmonary nodule by ultrasound. The investigators can get the changes in the size of the pulmonary nodule.
次要结局
未报告次要终点