A randomized, double-blind, double-dummy, positive controlled clinical trial of Hudi enteric-coated capsules, mesalazine, and combination therapy for active ulcerative colitis (damp-heat syndrome)

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR1800016668

Enrollment

Unknown

Registered

2018-06-14

Start date

2014-10-22

Completion date

Unknown

Last updated

2018-06-18

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

Conditions

Active ulcerative colitis

Interventions

test group:Hudi enteric-coated capsules+Mesalazine enteric-coated tablets Simulator

Positive control group:Mesalazine enteric-coated tablets+Hudi Enteric-coated Capsule Simulator

Combined group:Hudi enteric-coated capsules+Mesalazine enteric-coated tablets

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Meet the mild to moderate diagnostic criteria for active ulcerative colitis; 2. TCM Syndrome is a hot and humid accumulation certificate; 3. Aged 18-65 years old, male or female; 4. Those who voluntarily participate in the clinical trial and have signed the informed consent form, and the process of obtaining the informed consent shall comply with ethical principles.

Exclusion criteria

Exclusion criteria: 1. Patients with remission and severe activity; 2. Pregnancy, lactation, or recent fertility plan; 3. Serious allergies or those known to be allergic to tiger enteric-coated capsules and mesalazine-enteric tablets; 4. With serious cardiovascular and cerebrovascular diseases (Chronic Heart Failure New York grading standard heart function above grade III, severe arrhythmia, severe apoplexy sequelae), liver and kidney and hematopoietic system and other serious primary diseases, including blood ALT, AST> Normal upper limit, blood Cr> normal upper limit; 5. Severe complications of ulcerative colitis, such as local stenosis, intestinal obstruction, intestinal perforation, multiple polyps in the intestine, toxic megacolon, rectal cancer, etc.; 6. Mental disorders, mental disorders patients; 7. Is taking glucocorticoids, immunosuppressants or biological agents to treat patients; 8. Patients who participated in other drug clinical trials in the past 3 months; 9. Researchers consider it inappropriate to participate in clinical trials.

Design outcomes

Primary

Measure	Time frame
Clinical efficiency rate;Clinical remission rate;	—

Secondary

Measure	Time frame
Endoscopic response rate;Mucosal healing rate;TCM symptom score;Physical and chemical indicators: Erythrocyte sedimentation rate, C-reactive protein;	—

Countries

China

Contacts

Public ContactShen Hong

Affiliated Hospital of Nanjing University of Traditional Chinese Medicine (Jiangsu Province Traditional Chinese Medicine Hospital)

shenhong999@163.com+86 025-86618472

Outcome results

None listed

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