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A clinical study based on gut metagenomics to explore the regulation of intestinal microecology by the modified Huangqi Baijiashao Decoction in the prevention and treatment of colorectal

A clinical study based on gut metagenomics to explore the regulation of intestinal microecology by the modified Huangqi Baijiashao Decoction in the prevention and treatment of colorectal

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026001234
Enrollment
Unknown
Registered
2026-05-14
Start date
2026-06-01
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

Colorectal adenoma

Interventions

Experimental group:Take the modified Astragalus and Softshell Turtle Decoction Granules once a day, 1 bag each time, and take it by dissolving in water.
Control group:Take the modified Astragalus and Softshell Turtle Decoction Comfort Granules once a day, 1 bag each time, and take it by dissolving in water.

Sponsors

Shanghai Putuo District Traditional Chinese Medicine Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) After the polyp removal surgery under colonoscopy, the age range is 18 to 75 years old; (2) The pathological diagnosis is: tubular adenoma, tubulovillous adenoma, villous adenoma, and serrated adenoma; (3) The TCM syndrome type is consistent with spleen deficiency with blood stasis syndrome; (4) The diet is relatively stable, not a vegetarian, able to complete the questionnaire, and voluntarily signed the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Patients with familial adenomatous polyposis, PJ syndrome, inflammatory bowel disease, etc. as indicated by colonoscopy; (2) Regular use of COX-2 inhibitors, NSAIDs, calcium supplements, Vitamin D, probiotics, etc. medications; (3) Patients who have undergone partial or total gastrectomy or local resection of the colon and rectum, and are intolerant to colonoscopy; (4) Patients with severe diseases such as heart, brain, lung, liver, kidney, nervous system, hematopoietic system or malignant tumors; (5) Abnormal liver and kidney function, defined as: creatinine > 1.5 times the upper limit of normal (ULN), and/or AST, fourteen Shanghai Pu Zhou District Health System Scientific and Technological Innovation Project Plan Task Sheet (2026 Edition) ALT > 2.0×ULN, and/or total bilirubin > 1.5×ULN; (6) The subject has an allergic constitution or is known to be allergic to the ingredients of the test medication; (7) Pregnant women, lactating women, and patients with mental disorders; (8) Patients with a BOSTON intestinal preparation score of = 7 points, and those whose colonoscopy withdrawal time is = 6 minutes; (9) Subjects who have taken antibiotics or probiotics in the past 3 months before the test.

Design outcomes

Primary

MeasureTime frame
Changes in the abundance and diversity of gut microbiota;

Secondary

MeasureTime frame
Recurrent rate, recurrence rate; 8/5000 Pathological nature of colon polyps;Traditional Chinese Medicine Syndrome Score;Gastrointestinal symptom score;

Countries

China

Contacts

Public ContactDai Xiaoling

Shanghai Putuo District Traditional Chinese Medicine Hospital

553137182@qq.com18817773729

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Jun 11, 2026