Skip to content

Efficacy of Herbal enema prescriptionII(DHEP II) in the treatment of mild or moderate active symptoms of ulcerative colitis:A multicenter prospective randomized control clinical trial.

Efficacy of Herbal enema prescriptionII(DHEP II) in the treatment of mild or moderate active symptoms of ulcerative colitis:A multicenter prospective randomized control clinical trial.

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR1900002594
Enrollment
Unknown
Registered
2019-09-13
Start date
2019-12-01
Completion date
Unknown
Last updated
2023-02-20

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

Conditions

Ulcerative colitis

Interventions

Sponsors

Nanjing Hospital of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Patients meeting the Western diagnostic criteria for ulcerative colitis(See the research proposal for details); (2) Comply with the diagnostic criteria for TCM syndromes of ulcerative colitis(See the research proposal for details); (3) The condition is mild to moderate active patients aged 18-75 years; (4) No history of diarrheal disease or other gastrointestinal diseases in the past 4 weeks; (5) Antibiotics and microecological preparations were not taken within the past 1 month; (6) Signed into the study informed consent form.

Exclusion criteria

Exclusion criteria: (1) There are serious complications, such as local stenosis, intestinal obstruction, intestinal perforation, rectal insufficiency, toxic colon expansion, colon cancer, rectal cancer and anal diseases; (2) Women who are pregnant or are preparing for pregnancy, lactating women; (3) Allergies and those who are allergic to multiple drugs; (4) Patients with serious diseases such as liver, kidney, hematopoietic system and endocrine system and mental patients; (5) The condition is critical and it is difficult to make a definitive evaluation of the effectiveness and safety of the new drug.

Design outcomes

Primary

MeasureTime frame
relapse Intervals;

Secondary

MeasureTime frame
albumin;Evaluation criteria for mucosal lesions;Truelove-Witts;ESR;Mayo index;Comprehensive efficacy criteria;Calprotectin;IL6;HB;Safety evaluation standard;TNF-a;Intestinal flora;TCM symptom evaluation criteria;CRP;

Countries

China

Contacts

Public ContactDing Kang

Department of Anorectal Surgery, Nanjing Hospital of Chinese Medicine

51422503@qq.com+86 18951755243

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026