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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: JPRN
Last refreshed on: 17 October 2023
Main ID:  JPRN-jRCTs031190156
Date of registration: 09/12/2019
Prospective Registration: Yes
Primary sponsor: Kanai Takanori
Public title: IN for practical use
Scientific title: Study on efficacy and safety of indigo naturalis in patients with intractable ulcerative colitis.
Date of first enrolment: 09/12/2019
Target sample size: 100
Recruitment status: Recruiting
URL:  https://jrct.niph.go.jp/latest-detail/jRCTs031190156
Study type:  Interventional
Study design:  single arm study, open(masking not used), uncontrolled control, single assignment, treatment purpose  
Phase:  3
Countries of recruitment
Contacts
Name: Yusuke    Yoshimatsu
Address:  35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582 160-8582 Tokyo Japan
Telephone: +81-3-5843-7090
Email: yyyy1y8yyyy@keio.jp
Affiliation:  Keio University Hospital
Name: Takanori    Kanai
Address:  35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582 160-8582 Tokyo Japan
Telephone: +81-3-5843-7090
Email: takagast@z2.keio.jp
Affiliation:  Keio University Hospital
Key inclusion & exclusion criteria
Inclusion criteria: 1)Patients who are applied to the diagnostic criteria of ulcerative colitis (UC).
2)Patients with steroid-dependent or steroid-refractory active UC, or with active UC who are refractory to at least one of the other conventional therapies(tacrolimus,biological products, and low molecular weight compound)
3)Patients with 4 points or more Mayo score and 1 point or more endoscopic Mayo score.
4)16-year-old or older patients who agreed to this trial, and when patients who are younger than 20 years old, their
legal representatives also have to agree to the trial.

Exclusion criteria: 1.Patients who are clinically classified into severe or fulminant condition or have other conditions besides UC,such as infectious enteritis and so on. 2.Patients with symptomatic stenosis. 3.Patients who are planned to undergo surgery or patients who have experienced adverse effect or allergy of herbal medicines, and patients who have had herbal medicine which contains IN. 4. Patients with severe infection, severe heart disease,2.0 mg per dl or higher serum creatinine levels, 50IU per l or higher serum AST and ALT levels, malignant tumor or its previous history. 5.Patients who have possibility of pregnancy, or patients in nursing, or patients who hope to get pregnant. 6.Patients who are decided to be inappropriate for other reason by attending doctors.

Age minimum: >= 16age old
Age maximum: Not applicable
Gender: Both
Health Condition(s) or Problem(s) studied
ulcertive colitis
Intervention(s)
administration of one indigo naturalis FC enteric-coated tablet (including 0.5g indigo naturalis per tablet)twice a day for 4 weeks
Primary Outcome(s)
Rates of clinical remission at 8 weeks
Secondary Outcome(s)
1. Clinical remission rate at week 24
2. Mayo score at week 8 and 24
3. Rate of Mayo endoscopic score of 0 at week 8 and 24
4. Partial Mayo score at week 8 and 24
5. Lichtiger score at week 4, 8, and 24
6. Electrocardiographic, chest X-ray, and echocardiographic findings before and after drug administration
7. Safety during the trial period
Secondary ID(s)
Nil known
Source(s) of Monetary Support
Secondary Sponsor(s)
Ethics review
Status: Approval
Approval date:
Contact:
med-rinri-jimu@adst.keio.ac.jp
Certified Review Board of Keio
+81-3-5363-3503
med-rinri-jimu@adst.keio.ac.jp
Results
Results available:
Date Posted:
Date Completed:
URL:
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