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Clinical evaluation of traditional Chinese medicine on mild active ulcerative colitis: a multi-center, randomized, double-blind, controlled trial

Clinical evaluation of traditional Chinese medicine on mild active ulcerative colitis: a multi-center, randomized, double-blind, controlled trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR1900002335
Enrollment
Unknown
Registered
2019-05-14
Start date
2019-05-20
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

Jiangsu Province Hospital of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Diagnosis is in line with the active period of ulcerative colitis; 2. According to the improved Mayo score standard, the condition is mild (score 3-5 points); 3. Differentiation of TCM syndrome is heat-dampness and stasis blocked accompanied with spleen and stomach weakness; 4. 18 to 65 years old; 5. Those who participate in this clinical study voluntarily, and have signed informed consent already.

Exclusion criteria

Exclusion criteria: 1. Patients during remission period, moderate and severe active periods; 2. Pregnancy, lactation, or birth planning recent ; 3. Severe allergy tendency and those who allergies to the known ingredients of mesalazine or Hudi Changrong capsules; 4. Combined with severe cardiovascular and cerebrovascular diseases (chronic heart failure, cardiac function is level III or above according to New York grading standard, severe arrhythmia, severe stroke sequelae). Liver, kidney and hematopoietic system has serious primary diseases, including blood ALT, AST and Cr over the normal upper limit; 5. Ulcerative colitis companied with serious complications, such as local stenosis, intestinal obstruction, intestinal perforation, multiple polyps in the intestine, toxic megacolon, rectal cancer, etc. 6. Patients with mental disorders and mental disorders; 7. Patients who have participated in other meidical clinical studies in the past 3 months; 8. In addition to mesalazine, patients are receiving other treatments for ulcerative colitis; 9. Seriously conditions which need to be carried on urgent treatments; 10. It is not appropriate to participate in this clinical research judged by the researchers.

Design outcomes

Primary

MeasureTime frame
Clinical remission rate;Clinical effective rate;

Secondary

MeasureTime frame
Mucosal healing rate;Single symptom score;TCM syndrome score;Quality of life score;Endoscopic response rate;

Countries

China

Contacts

Public ContactDong Yun

Science and Technology Department, Jiangsu Province Hospital of Chinese Medicine

13951792361@163.com+86 13951792361

Outcome results

None listed

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