The clinical efficacy of Japanese Cayratia Herb combined with mesalazine in the treatment of ulcerative colitis: a randomized controlled clinical trial

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

TCTR

Registry ID

TCTR20230913006

Enrollment

Registered

2023-09-13

Start date

2022-05-10

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

ulcerative colitis Japanese Cayratia Herb (Cayratia japonica (Thunb.) Gagnep)

Interventions

Japanese Cayratia Herb (Cayratia japonica (Thunb.) Gagnep) enema and enema method: 60 g of Japanese Cayratia Herb (Cayratia japonica (Thunb.) Gagnep) enema was boiled with 250 mL water for 20 min. Mes

Experimental Drug,Placebo Comparator Drug

Japanese Cayratia Herb (Cayratia japonica (Thunb.) Gagnep) enema combined with mesalazine enteric-coated tablets orally,normal saline enema combined with mesalazine enteric-coated tablets orally

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) Meet the above diagnostic criteria and syndrome differentiation criteria; (2) No history of diarrhea or other gastrointestinal diseases in the past 4 weeks; (3) No antibiotics and microecologics in the past 1 month; (4) Patients voluntarily joined this study and signed informed consent.

Exclusion criteria

Exclusion criteria: (1) Combined with severe complications of UC, such as local stenosis, intestinal obstruction, intestinal perforation, rectal rest, toxic colon dilatation, colon cancer, rectal cancer and anal disease; (2) Pregnant or preparing for pregnancy, lactating women; (3) Allergic constitution and multiple drug allergies; (4) Combined with liver, kidney, hematopoietic system, endocrine system and other serious diseases and malignant tumors; (5) Researchers who have participated in or are participating in other trials within the past 1 month; (6) Patients with mental disorders.

Design outcomes

Primary

Measure	Time frame
Ulcerative colitis activity score Before treatment,After treatment which included defecation frequency, hematochezia, endoscopic findings, and overall rating of physicians, with lower scores having lower activity.	—

Secondary

Measure	Time frame
Total effective rate After treatment Complete remission, effective, ineffective,Laboratory indexes Before treatment,After treatment interleukin-6, interleukin-12, interleukin-10, transforming growth factor	—

Countries

China

Contacts

Public ContactLijiang Ji

Changshu Hospital Affiliated to Nanjing University of Chinese Medicine

ji512@163.com13962340746

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026