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Effectiveness of Jianpi Huashi Bushen Granule in the Treatment of Ulcerative Colitis: A Randomized Controlled Clinical Trial

Effectiveness of Jianpi Huashi Bushen Granule in the Treatment of Ulcerative Colitis: A Randomized Controlled Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025001355
Enrollment
Unknown
Registered
2025-07-09
Start date
2024-12-12
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 colitis

Interventions

Treatment group:Jianpi Huashi Bushen granule
Control group:Mesalazine + Jianpi Hua dampness bushen granule simulator

Sponsors

Shuguang Hospital affiliated to Shanghai University of TCM
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) Aged 18-75 years old; 2) The clinical diagnosis was ulcerative colitis; 3) TCM syndrome is in line with spleen-kidney Yang deficiency type; Sign informed consent have good compliance with the observation and treatment of researchers and voluntarily participate.

Exclusion criteria

Exclusion criteria: 1)Intestinal inflammatory diseases caused by other causes: bacterial dysentery amoebic dysentery chronic schistosomiasis intestinal tuberculosis and other infectious colitis and Crohn's disease ischemic enteritis radiation enteritis high-grade intraepithelial neoplasia of the rectum stool virus or bacteria test positive patients; 2)Combined with serious underlying diseases such as cardiovascular and cerebrovascular liver kidney lung and other serious primary diseases and other serious complications; 3)Severe gastrointestinal diseases: toxic megacolon gastrointestinal tumor gastrointestinal perforation gastrointestinal hemorrhage intestinal obstruction etc.; 4)Have serious mental disorders communication barriers unable to cooperate with diagnosis and treatment; 5)Pregnant and lactating women or women of gestational age who are preparing for pregnancy and patients who are allergic to therapeutic drugs; 6)Patients who have taken drugs that should not be shared with mesalazine such as thiguanine mercaptopurine ampicillin prosulfa warfarin methotrexate folic acid etc. in the past 1 week or who have received varicella vaccine or steroid drugs such as prednisone; 7)Patients who participated in other clinical trials within the past 1 month; 8)Patients who have used biologics within the past 1 month; 9)Severe allergy and allergy to mesalazine or known components of Chinese medicine granules.

Design outcomes

Primary

MeasureTime frame
Mayo score;

Secondary

MeasureTime frame
Baron score;TCM syndrome score;ulcerative colitis endoscopic index of severity;Ulcerative Colitis-Symptom Questionnaire;truelove and witts classification;Geboes score;Inflammatory Bowel Disease Questionnaire;

Countries

China

Contacts

Public ContactWei-Wei Hao

Shuguang Hospital affiliated to Shanghai University of TCM

876421799@qq.com15621736859

Outcome results

None listed

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