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Traditional Chinese medicine Qingshen decoction combined with mesalazine for patients with moderately active ulcerative colitis: A randomized clinical trial

Clinical study of Qingshen Decoction with mesalazine on moderately active ulcerative colitis (dampness-heat syndrome of large intestine)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025001310
Enrollment
Unknown
Registered
2025-07-01
Start date
2024-02-29
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

ulcerative coliits

Interventions

experimental group:Qingshen decoction+ mesalazine

Sponsors

Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Patients who met the diagnostic criteria of UC colonoscopy within the last 1 month met the UC manifestations mucosal biopsy met the UC active stage manifestations the lesion range classification met the Montreal classification E1 E2 E3 and the disease severity classification was moderate UC (Mayo score 6-10); (2) In line with the TCM standards of large intestine damp-heat syndrome differentiation; (3) Age between 18 and 75 years old regardless of gender; (4) Voluntary and signed informed consent.

Exclusion criteria

Exclusion criteria: (1) Those who were or were being treated with anti-TNF hormones methotrexate antibiotics or other biologics within 3 months prior to inclusion; (2) severe liver and kidney dysfunction other autoimmune diseases or malignant tumors; (3) Patients with bacterial dysentery intestinal tuberculosis and other infectious intestinal diseases as well as ischemic enteritis colorectal cancer and other intestinal diseases Tao disease; (4) Patients with a history of severe mental illness; (5) Patients with Chinese or western drug allergy and intolerance in this study; (6) Pregnant and lactating women.

Design outcomes

Primary

MeasureTime frame
Clinical remission rate of UC;

Secondary

MeasureTime frame
Mucosal healing rate after treatment;Total effective rate of TCM syndromes;The recovery rate of symptoms after treatment;Changes in symptoms before and after treatment;UC clinical response rate;

Countries

China

Contacts

Public ContactJiang Lin

Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

linjiang@longhua.net021-64385700-3925

Outcome results

None listed

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