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临床试验/ITMCTR2000004105
ITMCTR2000004105招募中未知

Innovative research on the pathogenesis of myasthenia gravis in traditional Chinese medicine (N-of-1)

The First Affiliated Hospital of Guangzhou University of Chinese Medicine0 个研究点开始时间: 待定最近更新:
适应症

试验速览

阶段
未知
状态
招募中
发起方

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional study

入排标准

年龄范围
18 至 65(—)
性别
All

入选标准

  • 1) Patients aged between 18 to 65 years;
  • 2) Patients diagnosed with MG based on The Chinese guidelines for the diagnosis and treatment of myasthenia gravis (2020): patients with typical clinical features of MG (fluctuating myasthenia) excluded from other diseases and meeting any of the following three points, including pharmacological examination, electrophysiological characteristics or serum antibody detection;
  • 3) Patients attached to the spleen-stomach deficiency syndrome or spleen-kidney deficiency syndrome will be enrolled which is based on The guidelines for clinical diagnosis and treatment of internal medicine of traditional Chinese Medicine: myasthenia gravis (2020);
  • 4) Patients identified as class II or III according to myasthenia gravis foundation of America (MGFA) clinical classification and are in the stable stage of MG at least 3 months;
  • 5) Patients with Quantitative Myasthenia Gravis (QMG) score more than 6;
  • 6) Patients treated with glucocorticoid administration should not take more than 15mg prednisone (or an equivalent dose of other glucocorticoids) per day.

排除标准

  • 1) Female patients who are pregnant or lactating or have a pregnancy plan during the trial;
  • 2) Patients with other autoimmune diseases (e.g., polymyositis, multiple sclerosis, rheumatoid arthritis) that may impact the assessment and treatment;
  • 3) Patients with severe heart, kidney, liver, lung, hematological system, infectious diseases or cancer;
  • 4) Patients with neuropsychiatric disorders that cannot cooperate;
  • 5) Patients received plasma exchange, glucocorticoid or gamma-globin pulse therapy within 3 months;
  • 6) Patients received thymectomy within half a year;
  • 8) Patients participating in other trials;
  • 9) Patients consumed antibiotics, probiotics or anti-acids during the previous two months.

研究者

发起方
The First Affiliated Hospital of Guangzhou University of Chinese Medicine

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