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A randomized controlled, multicenter clinical trial of healing (ulcerated enema II) for mild to moderate ulcerative colitis (active phase)

A randomized controlled, multicenter clinical trial of healing (ulcerated enema II) for mild to moderate ulcerative colitis (active phase)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300076210
Enrollment
Unknown
Registered
2023-09-27
Start date
2023-10-01
Completion date
Unknown
Last updated
2023-10-03

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

Conditions

Mild to moderate ulcerative colitis

Interventions

Experimental group:In addition to the control group, a recessed enema was added once a night for 2 weeks
Control group:According to the "2018 Consensus Opinion on the Diagnosis and Treatment of Inflammatory Bowel Disease" for the treatment of mild to moderate ulcerative colitis, all subjects were given o

Sponsors

Nanjing Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Age 18-65 years old, male or female; (2) Meet the diagnostic criteria of Western medicine for mild to moderate ulcerative colitis (active stage); (3) Meet the diagnostic standards of traditional Chinese medicine, and the traditional Chinese medicine differentiation is the certificate of humid heat in the large intestine; (4) Those who agree to participate in the trial and voluntarily sign the informed consent form;

Exclusion criteria

Exclusion criteria: (1) Pregnant and women planning to become pregnant or lactating; (2) Other intestinal diseases (such as bacterial dysentery, acute infectious colorectitis, intestinal tuberculosis and Crohn's disease); (3) Serious intestinal complications (such as intestinal perforation, intestinal obstruction, toxic megacolon, colorectal cancer); (4) Those with allergies and known allergies to the drugs to be used in this trial; (5) Patients with serious primary diseases such as liver, kidney and hematopoietic system, and psychosis; (6) Patients who have participated in clinical trials of other drugs within 4 weeks; (7) Proctitis, rectal stenosis, even obstruction, severe bleeding and fistula formation, requiring surgical treatment; (8) Severe anemia (Hb<60g/L).

Design outcomes

Primary

MeasureTime frame
Clinical response rate;

Secondary

MeasureTime frame
Clinical remission;Mucosal healing rate;Mitigation maintenance situation;Efficacy of TCM symptoms;

Countries

China

Contacts

Public ContactDing Kang

Nanjing Hospital of Traditional Chinese Medicine

dingkang@njucm.edu.cn+86 189 5175 5243

Outcome results

None listed

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