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Clinical study of Sanzi Decoction regulating intestinal flora and tumor-related protein expression to improve postoperative recurrence of colorectal adenoma

Clinical study of Sanzi Decoction regulating intestinal flora and tumor-related protein expression to improve postoperative recurrence of colorectal adenoma

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400086322
Enrollment
Unknown
Registered
2024-06-28
Start date
2021-09-24
Completion date
Unknown
Last updated
2024-07-08

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 treatment group:After operation, Sanzifang granules (provided by Tianjiang Pharmaceutical) were administered with 1 dose per day and boiled water twice for 3 months.
Placebo control group:After operation, Sanzifang granule simulation (provided by Tianjiang Pharmaceutical) was administered with 1 dose per day and boiled water twice for 3 months.
Healthy control group:NA

Sponsors

Jiangsu Province Hospital of Integrated Chinese and Western Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Conforming to the criteria of colorectal adenoma diagnosis and TCM syndrome differentiation. (2) Gender is not limited, age 40-65 years old. (3) The subject gives informed consent and signs relevant documents.

Exclusion criteria

Exclusion criteria: (1) Patients who do not meet the diagnostic criteria for the above diseases; (2) Patients who have been diagnosed with familial adenomatous polyposis, Peutz-Jeghers polyposis, or Turcot syndrome; (3) The adenoma has been proved by pathology to be cancerous (including severe atypical hyperplasia); (4) Patients with grade D cleanliness of intestinal preparation in colonoscopy; (5) Patients with serious primary diseases of the heart, brain, liver, kidney and hematopoietic system, mental diseases, pregnant or pregnant women, breastfeeding women, allergic and allergic to multiple drugs; (6) Suspected or have a history of alcohol or drug abuse; (7) Other diseases that reduce the possibility of enrollment or complicate enrollment, such as frequent changes in the working environment, are likely to cause loss of follow-up according to the judgment of the investigator; (8) allergies, such as allergies to two or more drugs or food; Or known allergy to the ingredients of the drug; (9) History of antibiotic use within the last two months; (10) Patients who are participating in other clinical studies; (11) Drugs being taken or required to be taken during the study that may affect the evaluation of the effectiveness of the drug in the study: metformin, non-steroidal anti-inflammatory drugs (such as aspirin, ibuprofen, diclofenac, etc.), cox-2 inhibitors (such as celecoxib, etc.), calcium and other traditional Chinese medicine.

Design outcomes

Primary

MeasureTime frame
Adenoma number;Adenoma Size;

Countries

China

Contacts

Public ContactZhongyi Li

Jiangsu Province Hospital of Integrated Chinese and Western Medicine

15850536069@163.com+86 158 5053 6069

Outcome results

None listed

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