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A single-center;non-randomized-controlled registration study of modified Sanren Kushen Decotion treating ulcerative colitis in the active stage with multi-dimensions

Real-World Research on the Evolution of Symptoms in the Active Stage of Ulcerative Colitis and the Multi-dimensions Treatment of Sanren Kushen Decotion

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025000153
Enrollment
Unknown
Registered
2025-01-19
Start date
2025-02-01
Completion date
Unknown
Last updated
2025-02-03

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

Conditions

ulcerative colitis

Interventions

experimental group-RD:Oral mesalazine placebo and SRKSD+BTWD instant granules
control subjects:Oral mesalazine and SRKSD placebo
experimental group-PX:Oral mesalazine placebo and SRKSD+HSSD instant granules
experimental group-SR:Oral mesalazine placebo and SRKSD instant granules
experimental group-HR:Oral mesalazine placebo and SRKSD+WMWD instant granules
experimental group-GY:Oral mesalazine placebo and SRKSD+SNSD instant granules

Sponsors

Hospital of Chengdu University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Patients whose Western medicine diagnosis conforms to those in the active stage of ulcerative colitis; 2. According to the modified Mayo scoring standard the condition belongs to mild to moderate (score 3-10); 3.Those aged between 18 and 65 years old; 4.Those who voluntarily participate in this clinical research and have signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1.Pregnant lactating women or those with a recent plan for childbearing; 2.Those with a severe allergic constitution and allergies to mesalazine or known components of traditional Chinese medicine; 3. Those with combined severe primary diseases such as severe cardiovascular and cerebrovascular diseases liver and kidney diseases and hematopoietic system disorders; 4.Those with ulcerative colitis having severe complications such as local stenosis intestinal obstruction intestinal perforation multiple intestinal polyps toxic megacolon rectal cancer etc.; 5.Patients with mental disorders or intellectual disabilities; 6. Patients who have participated in other drug clinical studies within the recent 3 months; 7.Patients who are undergoing other treatment regimens for ulcerative colitis in addition to mesalazine treatment.

Design outcomes

Primary

MeasureTime frame
the Mayo score;—

Secondary

MeasureTime frame
IBD-Q:quality of life score;Mucosal healing rate;Endoscopic response rate;Single symptom score;TCM syndrome score;—

Countries

China

Contacts

Public ContactPeimin Feng

Hospital of Chengdu University of Traditional Chinese Medicine

fpmvv@126.com18981885791

Outcome results

None listed

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