Investigation of clinical efficacy of Qing-Dai for patients with crohn's disease who have the loss of responsiveness for anti-TNF agents

Investigation of clinical efficacy of Qing-Dai for patients with crohn's disease who have the loss of responsiveness for anti-TNF agents - clinical efficacy of Qing-Dai for patients with crohn's disease

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000019249

Enrollment

Registered

2015-10-06

Start date

2015-10-15

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

Crohn&#39

Interventions

Eight weeks treatment of Qing-Dai (2g daily)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1 Japanese patient who is aged more than15 years 2 Patients were diagnosed according to the diagnostic criteria defined by the research group of inflammatory bowel disease in the Ministry of Health, Labor and Welfare in Japan. 3 Patients induced clinical remission by infliximab or adalimumab once, and then infliximab or adalimumab was used at least for 16 weeks after starting ofinfliximab or adalimumab. 4 Patients' CDAI was more than 175 at the entry and at last administration of infliximab or adalimumab

Exclusion criteria

Exclusion criteria: 1 Patients' CDAI was more than 450 or less than 150 at the entry 2 The patients were not treated with infliximab within 7 weeks. The patients were not treated with adalimumab within 10 days. 3 The presence of abdominal abscess 4 Patients had colitis-associated dysplasia. 5 Patients had symptomatic intestinal stenosis 6 Patients had pouch or stoma. 7 Patients have the history of side effect or allergy of Chinese herbal medicine. 8 Patients have serious infections. 9 Patients have serious heart disease 10 Serum creatinine is more than 2.0mg/dL 11 Total bilirubin is more than 2.0mg/dL or AST/ALT is more than 50IU/L 12 Patients have history of malignant diseases 13 Patients have obvious psychological disorders 14 Patients are pregnant or patients wish to conceive. 15 Changing the dose/addition/reduction of medication for CD within 12 weeks before the commencement of the study was not allowed. 16 Investigators regard the patients as the inappropriate person to enroll this clinical trial.

Design outcomes

Primary

Measure	Time frame
The rate of clinical remission (CDAI is less than 150 at 8 weeks after the entry)	—

Countries

Japan

Contacts

Public ContactMakoto Naganuma

School of Medicine, Keio University Division of Gastroenterology and Hepatology

maknaganuma@gmail.com03-3353-1211

Outcome results

None listed

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

Investigation of clinical efficacy of Qing-Dai for patients with crohn&#39;s disease who have the loss of responsiveness for anti-TNF agents