The treatment using indigo naturalis for autoimmune pancreatitis

JRCT ID: jRCTs051210171

Registered date:07/02/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Autoimmune pancreatitis
• Date of first enrollment: 26/02/2022
• Target sample size: 10
• Study type: Interventional
• Intervention(s): Administration of indigo naturalis

Outcome(s)

• Primary Outcome: Safety during the study

Secondary Outcome

1. Rate of remission at 2 weeks
2. Rate of remission at 8 weeks
3. Rate of remission at 24 weeks
4. Evaluation of the AhR-IL-22 pathway

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

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.

Exclude criteria

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

Related Information

• Primary Sponsor: Kamata Ken
• Source(s) of Monetary Support: Keio University School of Medicine