Colorectal adenom
Conditions
Interventions
Intervention Group:Investigational Product Drug Name: Modified CMF Pharmaceutical Characteristics Composition : Fructus Mume : 18g
Bombyx Batryticatus : 18g
Fructus Sophorae : 9g Dosage and Administration:Take 45g of granules with 200ml of warm water half an hour after breakfast and dinner daily. Treatment Course: 28-day cycle 6 consecutive cycles
Control Group:Investigational Product Drug Name: Berberine Hydrochloride Tablets
Dosage Strength: 0.1g Dosage and Administration:3 tablets (300mg) per dose Frequency: BID Treatment Course: 28-day cycle 6 consecutive cycles
Sponsors
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Shanghai University ofTraditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age between 18 and 75 years old regardless of gender. 2. Patients who have undergone endoscopic colorectal adenoma resection within the past 6 months with pathological confirmation of colorectal adenomatous polyps (CRA) and complete removal of the adenoma. 3. Traditional Chinese Medicine (TCM) syndrome differentiation indicating spleen deficiency with dampness retention. 4. Understanding and willingness to participate in the study along with signing the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Pregnant women lactating women and women planning to become pregnant. 2. Patients with uncontrolled psychiatric disorders who are unable to cooperate. 3. Patients with active tuberculosis cardiac hepatic renal diseases or other severe infectious diseases. 4. Patients requiring long-term use of aspirin (for 3 months or more with a daily dose of at least 100 mg) NSAIDs calcium supplements (for 3 months or more with a daily dose of at least 1200 mg) or metformin (for 3 months or more with a daily dose of at least 25 mg). 5. Patients with known allergies or intolerances to the study medications (modified CMF or berberine). 6. Patients who have been taking traditional Chinese herbal medicines or proprietary Chinese medicines with heat-clearing detoxifying phlegm-resolving and nodule-dissipating effects for a long period (6 months or more) prior to participating in this study especially those containing berberine components such as fried Coptis chinensis or Picrorhiza scrophulariiflora. 7. Patients who have participated in or are currently participating in other clinical trials within one month prior to joining this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1-Year Colorectal Adenoma Recurrence Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Adenoma-Free Survival;Freedom from Event (FFE);16S rRNA high-throughput sequencing analysis and untargeted metabolomics analysis; | — |
Countries
China
Contacts
Public ContactFu Xiaoling
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Shanghai University ofTraditional Chinese Medicine
Outcome results
None listed