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A single-center randomized standard-controlled open-label clinical study of the efficacy and safety of Andrographolide Drops in the treatment of patients with mild to moderately active ulcerative colitis

A single-center randomized standard-controlled open-label clinical study of the efficacy and safety of Andrographolide Drops in the treatment of patients with mild to moderately active ulcerative colitis

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025001085
Enrollment
Unknown
Registered
2025-05-31
Start date
2025-06-01
Completion date
Unknown
Last updated
2026-06-22

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

Conditions

Inflammatory bowel disease

Interventions

Combined treatment group:Mesalazine + Andrographolide
Conventional treatment group:Mesalazine

Sponsors

Huai'an First People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1: Chinese guidelines for the diagnosis and treatment of ulcerative colitis (2023 Xi'an) in adult patients with a clear diagnosis of mild to moderate active ulcerative colitis; 2: After fully assessing the risks/benefits physicians prescribe andrographolide to adults with ulcerative colitis; 3: Patients with mildly or moderately active ulcerative colitis 3 points = modified Mayo score = 10 points.and endoscopic finding score = 2; 4: Patients and must sign an informed consent form and study protocols/informed consent forms used for data collection data validation should comply with legal and regulatory requirements.

Exclusion criteria

Exclusion criteria: 1: Based on the Andrographolide instructions and the judgment of the treating physician the patient is not suitable for treatment with Andrographolide; 2: Those with organic intestinal pathology and significant complications; 3: Have severe primary cardiovascular lesions liver function exceeding 1.5 times the upper limit of normal abnormal renal function hematological lesions pulmonary disease or a serious illness that affects their survival 4: Patients who are participating in other clinical studies; 5: Patients who in the opinion of the investigator are not suitable for participation in this trial.

Design outcomes

Secondary

MeasureTime frame
Change in SCCAI scores from baseline levels at weeks 4 and 8;

Countries

China

Contacts

Public ContactHonggang Wang

Huai'an First People's Hospital

jgzwhg@njmu.edu.cn18851268720

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Jun 29, 2026