A clinical study on the Regulation of Intestinal Microenvironment in coIX Lachana Fujiang Powder for the prevention and Treatment of malignant neoplasia in advanced colorectal adenoma

Phase 1

• Conditions: colorectal adenoma

• Registration Number: ITMCTR2000003703
• Lead Sponsor: Shuguang Hospital affillated with Shanghai University of TCM

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Progressive colonic adenoma with clear pathological diagnosis refers to adenoma with > 25% villous structure diameter >=10 mm or adenoma with high-grade intraepithelial neoplasia, which meets one of the above conditions;
2. Aged between 18 and 75 years;
3. The TCM syndrome type conforms to the syndrome of dampness accumulation of spleen deficiency and stagnation of blood stasis and heat, and is intended to be treated with TCM;
4. Did not take antibiotics, aspirin, immunosuppressants and other drugs within three months;
5. no serious heart, liver, kidney, hematopoietic system diseases or other factors affecting drug evaluation;
6. The diet is relatively stable, can complete the questionnaire, and voluntarily sign the informed consent.

Exclusion Criteria

1. Patients with digestive tract diseases, metabolic diseases, cardiovascular diseases, liver diseases, neurological diseases and autoimmune diseases;
2. Take yogurt or probiotics regularly for a long time (2-3 times per week, more than 6 months);
3. Pregnant and lactating women;
4. Allergic to certain drugs in the prescription of Chinese medicine;
5. Have joined other clinical researchers;
6. The researcher considers it inappropriate to participate in the study.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
recurrence rate;