臨床研究等提出・公開システム

Japanese

Date of registration	Feb. 07, 2022
Last modified on	Mar. 21, 2024
Trial ID	jRCTs051210171

Scientific Title	Safety of indigo naturalis in patients with autoimmune pancreatitis (Indigo naturalis for autoimmune pancreatitis)
Public Title	The treatment using indigo naturalis for autoimmune pancreatitis (Indigo naturalis for autoimmune pancreatitis)

Contact for Scientific Queries	Name	Kamata Ken
	Affiliation	Kindai University Hospital
	Address	377-2,Ohno-Higashi,Osaka-Sayama,Osaka,Japan
	Telephone	+81-72-366-0221
	E-mail	ky11@leto.eonet.ne.jp
Contact for Public Queries	Name	Kamata Ken
	Affiliation	Kindai University Hospital
	Address	377-2,Ohno-Higashi,Osaka-Sayama,Osaka,Japan
	Telephone	+81-72-366-0221
	E-mail	ky11@leto.eonet.ne.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Feb. 07, 2022
Actual date of first enrollment		Feb. 26, 2022
Target sample size		10
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion 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.
	Exclusion 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
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Autoimmune pancreatitis
Intervention(s)		Administration of indigo naturalis
Health Condition(s) Keyword		Autoimmune pancreatitis
Intervention(s) Keyword		indigo naturalis
Health Condition(s) Code		084
Intervention(s) Code
Primary Outcome(s)		Safety during the study
Secondary Outcome(s)		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

Primary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support	Keio University School of Medicine
Secondary Sponsor	Not applicable

Name of Certified Review Board	Nara Medical University Certified Review Board
Address	840 Shijo-cho Kashihara, Nara, Nara
Telephone	+81-744-29-8835
E-Mail	ethics_nara@naramed-u.ac.jp
Approval Status	Approval
Date of approval	Jan. 26, 2022

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
9	Mar. 21, 2024	(this page)	Changes
8	Dec. 20, 2023	Detail	Changes
7	June. 01, 2023	Detail	Changes
6	Feb. 03, 2023	Detail	Changes
5	Jan. 24, 2023	Detail	Changes
4	Jan. 18, 2023	Detail	Changes
3	Sept. 12, 2022	Detail	Changes
2	Aug. 16, 2022	Detail	Changes
1	Feb. 07, 2022	Detail

List of change history