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Clinical study on the treatment of ulcerative colitis at the junction of the rectum and sigmoid colon with enema solution combined with mesalazine

Clinical study on the treatment of ulcerative colitis at the junction of the rectum and sigmoid colon with enema solution combined with mesalazine

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500107992
Enrollment
Unknown
Registered
2025-08-22
Start date
2022-01-03
Completion date
Unknown
Last updated
2025-08-25

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

Conditions

UC(ulcerative colitis)

Interventions

Monotherapy with oral Mesalazine (0.8 g TID) group:Patients received mesalazine orally at a dose of 0.8 g 3 times daily. The duration of treatment is 12 weeks.
LHT enema (100 mL QD) monotherapy group:LHT was prepared by decocting a mixture of Salvia plebeia, Rubia cordifolia charcoal, Lithospermum erythrorhizon, Galla chinensis, and Pulsatilla chinensis to a
Combination regimen group:Patients received mesalazine orally at a dose of 0.8 g 3 times daily. And the nightly enema is left in place for 2 hours. The duration of treatment is 12 weeks.

Sponsors

Jiangyin Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged 18-65 years; 2. Patients with ulcerative colitis in the rectosigmoid area; 3. Clinical symptoms Mayo score is 6-10 points.

Exclusion criteria

Exclusion criteria: 1. Other intestinal diseases (e.g., bacterial dysentery, intestinal tuberculosis, Crohn's disease); 2. Severe intestinal complications (e.g., intestinal perforation, obstruction, toxic megacolon, colorectal cancer); 3. Severe comorbidities, such as severe heart, liver, lung, or kidney disease; 4. Severe physical disability (e.g., blindness, deafness, muteness, intellectual disability, mental illness, or physical disability); 5. History of alcohol or drug abuse; 6. Participation in other concurrent clinical trials.

Design outcomes

Primary

MeasureTime frame
Mayo Score;

Secondary

MeasureTime frame
UCEIS Score;Gebos Score;Immunohistochemical analysis of NLRP3/Caspase-1 and Nrf2/HO-1 and macrophage expressions;the levels of TNF-a, IL-18, and IL-1ß;

Countries

China

Contacts

Public ContactMa Jiong

Jiangyin Hospital of Traditional Chinese Medicine

4538240@qq.com+86 510 8670 3799

Outcome results

None listed

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