Clinical efficacy and safety of oral Qing-Dai in patients with inflammatory bowel disease

Clinical efficacy and safety of oral Qing-Dai in patients with inflammatory bowel disease - Clinical efficacy and safety of oral Qing-Dai in patients with inflammatory bowel disease

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000022575

Enrollment

Registered

2016-06-02

Start date

2016-06-02

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcerative colitis,Crohn disease

Interventions

Patients take oral Qing-Dai in capsule form twice a day(daily dose,2g)for 4 weeks.If patients achieve clinical remission or show clinical response,they will be allowed to continue taking these drugs f

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Patients who have moderate to severe active ulcerative colitis(Left-sided or Extensive type,CAI=>6) or Crohn disease(CDAI=>220) 2)Adult patients 3)Patients with no change in treatment within the past 2 weeks before the commencement of the study 4)Patients who have never been treated with Qing-Dai 5)Patients who have received adequate information regarding this study and understood throughly,and then voluntarily submitted written consent forms upon participation in this study

Exclusion criteria

Exclusion criteria: 1)Pregnant or breastfeeding women 2)Patients who have a history of psychosomatic disorders 3)Patients who have a history of liver or renal diseases 4)Patients who have a history of antithrombotic therapy or thrombocytopenia 5)Patients who have a history of hepatitis B 6)Patients whom investigators and subinvestigators considered inappropriate to participate in this study

Design outcomes

Primary

Measure	Time frame
The rate of clinical remission at 4 weeks	—

Secondary

Measure	Time frame
1)The rate of clinical response and mucosal healing at 4 weeks 2)The rate of maintaining clinical remission,clinical response and mucosal healing at 52 weeks 3)Side effects of oral Qing-Dai 4)The changes of mucosal miRNA,microbiota,and inflammatory cytokines	—

Countries

Japan

Contacts

Public ContactAtsushi Hirano

Graduate School of Medical Sciences,Kyushu University Department of Medicine and Clinical Science

atsuhira@intmed2.med.kyushu-u.ac.jp092-642-5261

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026