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临床试验/JPRN-jRCTs051210171
JPRN-jRCTs051210171招募中2 期

Safety of indigo naturalis in patients with autoimmune pancreatitis - Indigo naturalis for autoimmune pancreatitis

Kamata Ken0 个研究点目标入组 10 人开始时间: 2022年2月7日最近更新:
适应症

试验速览

阶段
2 期
状态
招募中
发起方
入组人数
10

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
>= 20age old 至 ot applicable(—)
性别
All

入选标准

  • 1. Confirmed cases of naived autoimmune pancreatitis according to the clinical diagnosis criteria 2018 (For the patients previously treated with steroid more than 180 days or more should be passed since the latest administration.)
  • 2. Patients with abdominal symptoms
  • 3. Patients who are 20 years old or older at the time of consent
  • 4. Patients who can provide written consent in person.

排除标准

  • 1. Patients with a history of adverse reactions or allergies to Chinese herbal medicines
  • 2. Patients who have received other Chinese herbal medicines within 2 weeks prior to the registration date
  • 3. Patients with a history of pulmonary arterial hypertension
  • 4. Patients with obstructive jaundice
  • 5. Patients with retroperitoneal fibrosis, interstitial pneumonia, or tubulointerstitial nephritis who present
  • clinically problematic symptoms and signs
  • 6. Patients with pseudotumor of the liver or lung
  • 7. Patients with serious infectious diseases
  • 8. Patients with serum creatinine level of 2.0 mg/dl or higher
  • 9. Patients with AST or ALT levels of 50 IU/l or higher
  • 10. Patients who are pregnant, may become pregnant, are lactating, or wish to become pregnant during the study period
  • 11. Patients who are judged inappropriate for inclusion in this study by the physician in charge

研究者

发起方
Kamata Ken

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