Exploratory Clinical Trial to Evaluate the Efficacy and Safety of a Centella Asiatica Supplement for Ulcerative Colitis

JRCT ID: jRCTs031220305

Registered date:31/08/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Ulcerative Colitis
• Date of first enrollment: 31/08/2022
• Target sample size: 10
• Study type: Interventional
• Intervention(s): Processed tsujikusa powder (500mg) given on once a day for 12 weeks.

Outcome(s)

• Primary Outcome: Percentage of patients with clinical improvement after 4 weeks of treatment

Secondary Outcome

- Percentage of patients with endoscopic score improvement) after 12 weeks of treatment
- Percentage of patients with clinical improvement using the Mayo score after 12 weeks of treatment
- Percentage of patients with clinical improvement using SCCAI after 4 and 12 weeks of treatment
- Percentage of colorectal histopathology improvement after 12 weeks of treatment
- Changes in biomarkers (before, 4 weeks (blood test items only), and 12 weeks after treatment); CRP, LRG, and 1-hour erythrocyte sedimentation rate
- Centella Asiatica supplement-related adverse events
- Analysis of factors associated with the efficacy of tsuvoxa (patient background, type of ICI and duration from the start of ICI, medication adherence, Mayo score at enrollment, endoscopic score at enrollment, histopathology)
- Exploratory evaluation of the association between changes in epithelial cell differentiation markers (LGR5, CDX2, Atoh1, MUC2, TFF3, etc.) and damage markers (telomere length, apoptosis, p53 positive cells, SLFN11, etc.) and disease severity and treatment response

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Patients who have been diagnosed with ulcerative colitis for at least 6 months
2) Patients with a Partial Mayo score of 0-6 (mild to moderate disease) and a Mayo endoscopic subscore of 1 or higher
3) Patients aged 18 years or older
4) Patients with ECOG Performance status 0-2
5) Patients who have been fully informed about the study and who have given their voluntary written consent based on their full understanding of the study.

Exclude criteria

1) Patients diagnosed by lower gastrointestinal endoscopy as having an apparent cause of other diseases
2) Patients who have changed or are scheduled to change their ulcerative colitis medication in the 2 weeks prior to enrollment or 4 weeks after enrollment (a change in ulcerative colitis medication is considered an exacerbation of ulcerative colitis or the appearance of serious side effects of that medication)
3) Patients who are regular users of tuberculosis or formulation components
4) Patients with or suspected of having toxic megacolon or gastrointestinal perforation
5) Patients with other diseases that are poorly controlled at the time of enrollment
6) Patients with serious liver disease
7) Patients with serious renal disease
8) Patients with a history of hypersensitivity to Centella Asiatica or any of the ingredients of the formulation.
9) Pregnant women or women who may be pregnant
10) Women who are breast-feeding
11) Other patients who are judged to be inappropriate as subjects by the investigators.

Related Information

• Primary Sponsor: Tsuchiya Kiichiro
• Source(s) of Monetary Support: University of Tsukuba Hospital