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Jianggui Wenzhong Decoction Combined with Mesalazine in the Treatment of Ulcerative Colitis (Yang Deficiency of the Spleen and Kidney Pattern) in Remission Stage: A Randomized Controlled Trial

Jianggui Wenzhong Decoction Combined with Mesalazine in the Treatment of Ulcerative Colitis (Yang Deficiency of the Spleen and Kidney Pattern) in Remission Stage: A Randomized Controlled Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025000621
Enrollment
Unknown
Registered
2025-04-01
Start date
2025-03-06
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

Ulcerative colitis

Interventions

Combination group:Jianggui Wenzhong Decoction + Mesalazine
Western medicine group:Mesalazine

Sponsors

Hubei Provincial Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) It meets the diagnostic criteria for remission of ulcerative colitis in Western medicine (modified Mayo total score =2 points and no single sub-score > 1 point); (2) Meet the criteria for clinical response and histological response; (3) Those who meet the TCM syndrome differentiation as spleen-kidney Yang deficiency; (4) Age 18-70 years old gender is not limited; (5) Voluntarily participate in and sign the informed consent.

Exclusion criteria

Exclusion criteria: (1) Active persistent fulminant UC patients who are taking second-line therapy or additional therapy hormone dependent or hormone ineffective; (2) Severe complications such as local stenosis intestinal obstruction intestinal perforation massive bleeding rectal polyps toxic colon dilatation colon cancer rectal cancer and anal disease; (3) Patients with Crohn's disease undefined colitis ischemic colitis radiation colitis diverticulosis with colitis under the microscope and diarrhea and other infectious diarrhea; (4) Patients with liver kidney hematopoietic system endocrine system and other serious primary diseases and mental disorders; (5) Women who are pregnant or preparing to become pregnant breastfeeding women; (6) Allergic to the investigational drug and its ingredients; (7) Those who had used sulfoazopyridine (SASP) and 5-amino-salicylic acid (5-ASA) to no avail.

Design outcomes

Primary

MeasureTime frame
Recurrence rate;

Secondary

MeasureTime frame
Laboratory related examination;TCM syndrome score;Medication compliance;Life quality;Endoscopic mucosal histological score;

Countries

China

Contacts

Public ContactLIN AIZHEN

Hubei Provincial Hospital of Traditional Chinese Medicine

hb20190101@126.com18986111907

Outcome results

None listed

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