Skip to content

Based on targeting intestinal stem cells/GART and extracellular traps of neutrophils (NETs) to explore the systematic biological effect mechanism of Huangkui Lianchang enema in anti - inflammatory and rectifying deviation treatment of ulcerative colitis (randomized controlled study)

Based on targeting intestinal stem cells/GART and extracellular traps of neutrophils (NETs) to explore the systematic biological effect mechanism of Huangkui Lianchang enema in anti - inflammatory and rectifying deviation treatment of ulcerative colitis (randomized controlled study)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2024000702
Enrollment
Unknown
Registered
2024-11-13
Start date
2024-11-20
Completion date
Unknown
Last updated
2024-12-09

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

Conditions

Distal ulcerative colitis in mild to moderate active phase

Interventions

control group:Basic treatment+Salofalk (Mesalqin enema)
experimental group:Basic treatment+HKE

Sponsors

Jiangsu Provincial Hospital of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Meet the Western diagnostic criteria of UC: a. staging; b. mild to moderate; c. range of rectal or left colon; d.Mayo score 3-10, and Mayo endoscopic subscore above 2; (2) TCM syndrome differentiation is dampness-heat and intestinal syndrome or spleen deficiency and dampness syndrome; (3) Between 18 and 65 years old; (4) The patient himself has voluntarily signed the informed consent form.

Exclusion criteria

Exclusion criteria: amoebic dysentery chronic schistosomiasis intestinal tuberculosis and other infectious colitis Crohn's disease ischemic enteritis and radiation enteritis; (2) Patients with serious complications such as local stenosis intestinal obstruction intestinal perforation toxic colon dilatation massive bleeding colon cancer and rectal cancer; (3) Patients with other primary and secondary infectious diseases such as cholecystitis and pneumonia; (4) Those with a history of enema treatment within half a month; (5)They are currently being treated with glucocorticoids thiopurine drugs biological agents and probiotics; (6) Patients with serious cardiovascular liver gallbladder lung kidney and blood system diseases; (7) Allergic constitution such as a history of allergy to two or more drugs or food or a known allergy to investigational drugs; (8) Suspected or definite history of alcohol or drug abuse; (9) women during pregnancy or lactation; (10) Disabled patients (blind deaf dumb intellectual disabilities mental disorders physical disabilities); (11) According to the judgment of the researcher there are other lesions that reduce the possibility of enrollment or complicate the enrollment such as frequent changes in the working environment which are easy to cause loss to follow-up; (12) Patients who have participated in other clinical trials.

Design outcomes

Primary

MeasureTime frame
Clinical efficacy (clinical response rate clinical response efficiency);Efficacy of colonoscopy (endoscopic response rate mucosal healing rate);

Secondary

MeasureTime frame
Integration improvement and disappearance rate of individual symptoms;Changes from baseline in CRP ESR and fecal calferin;Efficacy of TCM syndrome;Endoscopic mucosal healing rate;

Countries

China

Contacts

Public ContactChen Yugen

Jiangsu Provincial Hospital of Chinese Medicine

yugen.chen@njucm.edu.cn15366087441

Outcome results

None listed

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