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A multicenter, prospective, randomized controlled clinical trial of Yiqijianpi Anticancer Prescription for the prevention and treatment of colorectal adenomatous polyps.

A multicenter, prospective, randomized controlled clinical trial of Yiqijianpi Anticancer Prescription for the prevention and treatment of colorectal adenomatous polyps.

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400084694
Enrollment
Unknown
Registered
2024-05-23
Start date
2024-05-25
Completion date
Unknown
Last updated
2024-05-27

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

Conditions

Colorectal adenomatous polyps

Interventions

Chinese Medicine Group:After the first endoscopic removal of colorectal polyps, continuous oral administration of traditional Chinese medicine (mainly to Yiqijianpi and detoxify method, the prescripti
Control group:According to 5% of the drug content of the treatment group, the placebo drug of the control group was made.

Sponsors

The Affiliated Traditional Chinese Medicine Hospital to Southwest Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Study 1: Clinical observation of TCM syndrome types in patients with colorectal adenomatous polyps: (1) Adults aged 18-80 years old, TCM syndrome type is spleen deficiency syndrome; (2) After polypectomy, the patient has colorectal adenoma confirmed by histological intestinal polyposis examination within 3 days (including adenomatous polyps, tubular adenomas, tubulo-villous adenomas and villous adenomas); (3) Sign the informed consent form and be able to cooperate with the study; Study 2: A multicenter, prospective, randomized controlled clinical trial of Yiqijianpi Anticancer Prescription for the prevention and treatment of colorectal adenomatous polyps: (1) adults aged 18-80 years; (2) Within 1 month of all intestinal polyps removed, and the histological intestinal polyposis test confirmed to be colorectal adenoma (including adenomatous polyps, tubular adenomas, tubulo-villous adenomas and villous adenomas); (3) Sign the informed consent form and be able to cooperate with the study

Exclusion criteria

Exclusion criteria: (1) Patients with serious underlying diseases, (2) patients with early cancer or malignant tumors confirmed by histological intestinal polyposis examination, and (3) patients with mental disorders or other conditions who cannot cooperate; (4) Those who regularly take aspirin, non-steroidal anti-inflammatory drugs, COX2 inhibitors, calcium or vitamin D and other drugs (5) Those who are allergic to drugs; (6) Subjects who are considered by the investigators to be unsuitable to participate in this trial.

Design outcomes

Primary

MeasureTime frame
Study 1: Distribution of tongue images in patients with colorectal adenomatous polyps.;Study 1: Pulse distribution in patients with colorectal adenomatous polyps.;Study 1: TCM syndrome type distribution in patients with colorectal adenomatous polyps.;Study 2: Occurrence of colorectal polyps: Observe the incidence of colorectal polyps at 6, 12, and 24 months, including the number, size, location, and pathological nature of polyps.;Study 2: General Condition: TCM Score.;

Countries

China

Contacts

Public ContactWusheng Li

The Affiliated Traditional Chinese Medicine Hospital to Southwest Medical University

58422840@qq.com+86 139 8275 8088

Outcome results

None listed

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