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Sijunzi decoction on prevention and treatment of recurrence of colorectal adenoma after resection: a multicenter, randomized controlled trial

Sijunzi decoction versus placebo for the prevention in recurrence of colorectal adenoma after resection: a multicenter, double-blinded,randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2200006688
Enrollment
Unknown
Registered
2022-10-06
Start date
2022-11-01
Completion date
Unknown
Last updated
2023-02-20

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

Conditions

colorectal adenoma

Interventions

Placebo Group:Placebo granules are taken orally, one tablet at a time, twice a day. The course of treatment is 12 months.
Sijunzi Decotion Group:Sijunzi Decoction formula granules are taken orally, one tablet at a time, twice a day. The course of treatment is 12 months.

Sponsors

Longhua Hospital, Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Patients with colorectal adenoma with definite pathological diagnosis and endoscopic adenoma resection (excluding hot polypectomy, hot snare polypectomy and argon plasma coagulation); 2. There is at least 1 but no more than 6 colorectal adenomas confirmed by histology (including tubular, tubulovillous, and villous adenoma) 4. The Boston Bowel Preparation Scale (BBPS)=7; 5. Aged from 18 to 75 years; 6. The score of spleen deficiency syndrome in TCM=20 within 2 weeks before joining the group; 7. Adequate organ function; 8. Within 2 weeks after resection; 9. Patients have informed consent and can cooperate with long-term follow-up.

Exclusion criteria

Exclusion criteria: 1. The adenoma was not completely removed in previous colonoscopy; 2. Taking aspirin, NSAIDS, COX2 inhibitors, vitamin D and calcium for a long time, and maintain systemic immunotherapy for a long time; 3. Pregnant women, lactating women and patients with mentor disorders; 4. Unable to take drugs orally, lack of physical integrity of the upper gastrointestinal tract, malabsorption syndrome and other diseases that investigators consider may interfere with gastrointestinal movement or absorption; 5. Acute and chronic diseases complicated with severe heart,cerebral, liver, or kidney disease, severe postoperative complications and other conditions that may seriously affect the interventions and prognosis; 6. Other situations that researchers consider participants are not suitable for inclusion.

Design outcomes

Primary

MeasureTime frame
the recurrence of colorectal adenoma;

Secondary

MeasureTime frame
the score of spleen deficiency syndrome;the recurrence of colorectal adenoma;Pathological types of colorectal adenoma;

Countries

China

Contacts

Public ContactXu Hanchen
hanson0702@126.com13564103399

Outcome results

None listed

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