Colorectal adenoma
Conditions
Interventions
Methylthioninium Chloride Enteric-coated Sustained-release Tablets:Oral Methylthioninium Chloride Enteric-coated Sustained-release Tablets
Sponsors
The Second Hospital of Hebei Medical University
Eligibility
Sex/Gender
All
Age
45 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Subjects must be aged 45 to 75 years, inclusive. 2.Subjects scheduled to undergo colonoscopy for colorectal tumor screening or surveillance. 3.Have signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Subjects with contraindications to colonoscopy or Methylthioninium Chloride Enteric-coated Sustained-release Tablets; 2.Pregnant or lactating women; 3.Subjects with obvious alarm symptoms or signs of colorectal cancer (CRC), including hematochezia, melena, unexplained anemia, weight loss, abdominal mass, and positive rectal examination; 4.A history of colorectal resection; 5.Subjects with Lynch syndrome or familial adenomatous polyposis; 6.Subjects who have taken antiplatelet drugs such as aspirin or clopidogrel within 7 days before colonoscopy; 7.Subjects with a confirmed diagnosis of glucose-6-phosphate dehydrogenase (G6PD) deficiency; 8.Subjects taking selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), or tricyclic antidepressants at the time of screening; 9.Colonoscopy insertion failure due to any reason (e.g., inability to pass the endoscope due to obstruction, or inability of the patient to tolerate the examination) or failure of the colonoscope to reach the cecum.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adenoma detection rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| SSL detection rate;Polyp detection rate; | — |
Countries
China
Contacts
Public ContactDongmei Yao
The Second Hospital of Hebei Medical University
Outcome results
None listed