Skip to content

The Effectiveness and Safety of Methylene Blue Enteric-Coated Sustained-Release Tablets on Colorectal Screening in Patients with metabolic syndrome: A Prospective, Randomized, Placebo-Controlled, Single-Center Clinical Study

The Effectiveness and Safety of Methylene Blue Enteric-Coated Sustained-Release Tablets on Colorectal Screening in Patients with metabolic syndrome: A Prospective, Randomized, Placebo-Controlled, Single-Center Clinical Study

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500109353
Enrollment
Unknown
Registered
2025-09-17
Start date
2025-10-01
Completion date
Unknown
Last updated
2025-09-22

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

Conditions

Benign tumor of colon

Interventions

Methylene blue enteric-coated sustained-release Tablets group:(1)Before taking the first dose of methylene blue enteric-coated sustained-release tablets orally, drink the first liter of intestinal cle
placebo group:(1)Before taking the first dose of the oral placebo, drink the first liter of the intestinal cleansing preparation (compound polyethylene glycol electrolyte Powder) first. (2) After comp

Sponsors

The Air Force Hospital of Northern Theater PLA
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) Age 40 to 70 years old, gender not limited. (2) Patients with a clear diagnosis of metabolic syndrome; (3) Normal coagulation function; (4) Fully understand the content of the trial, voluntarily participate in the trial and be able to complete the trial process, and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1) Suffering from liver cirrhosis (abnormal coagulation function), blood diseases that cause abnormal coagulation, and autoimmune diseases that may lead to delayed ulcer healing; (2) Those who have used antithrombotic drugs (such as aspirin, clopidogrel, heparin, etc.), NSAIDs, glucocorticoids, etc. within one week before the operation and need to resume the use of the above-mentioned drugs after the operation; (3) Patients with a history of gastrointestinal obstruction, perforation, severe diverticulitis or major colectomy; (4) Patients with contraindications for colonoscopy (such as severe cardiopulmonary insufficiency, liver and kidney insufficiency, cachexia); (5) Pregnant and lactating women, as well as those who may conceive or are preparing for pregnancy in clinical trials; (6) Those who have an allergic reaction to enteric-coated sustained-release methylene blue; (7) Patients with a history of gastrointestinal malignancies in the past; (8) Other participants who the researchers consider unsuitable for the trial. Refusal to participate or inability to provide informed consent (9) Those who lack the ability to act independently, cannot correctly express their chief complaints, such as those with mental illness or severe neurosis, and are unable to cooperate with this trial; (10) Those who have participated in clinical trials of other drugs/devices and used the trial drugs/devices within three months prior to enrollment.

Design outcomes

Primary

MeasureTime frame
Detection rate of non-polypoid lesions;Detection rate of adenoma;Detection rate of serrated adenoma;Detection rate of laterally spreading tumor(LST);

Countries

People's Republic of China

Contacts

Public ContactShao Lichun

The Air Force Hospital of Northern Theater PLA

slc700214@163.com+86 1332446933

Outcome results

None listed

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