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The safety and effectiveness of 2% vitamin C solution for endoscopic iodine staining: a multicenter, randomized, double-blind, parallel-controlled trial

2% vitamin C solution spray for relief of irritation caused by Lugol’s stain in chromoendoscopy

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900022000
Enrollment
Unknown
Registered
2019-03-19
Start date
2019-04-01
Completion date
Unknown
Last updated
2019-03-25

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

Conditions

esophageal lesion

Interventions

2:5% sodium thiosulfate solution
3:2% vitamin C solution

Sponsors

The First Afliated Hospital with Nanjing Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. aged 50-75 years old, male or female; 2. General gastroscopy is required for routine diagnosis; 3. Sign the informed consent form and follow the research requirements.

Exclusion criteria

Exclusion criteria: 1) Pregnant or lactating women; 2) There are other serious diseases affecting the evaluation of this study, such as severe liver disease, heart disease, kidney disease, malignant tumor and alcoholism, bleeding, perforation, pyloric obstruction, and cancer complications; 3) The patient is required to undergo general anesthesia gastroscopy; 4) History of iodine staining in previous gastroscopies; 5) The patient cannot correctly express his or her complaint, such as mental illness, severe neurosis, unable to cooperate with the tester; 6) History of esophageal cancer, reflux esophagitis, esophageal varices, esophageal ulcers; 7) Patients with esophageal and gastric mucosal biopsy contraindications (coagulation dysfunction, taking anticoagulants, etc.); 8) allergic to iodine, vitamin C, or sodium thiosulfate; 9) with acid refluxing symptoms at the time of presentation.

Design outcomes

Primary

MeasureTime frame
Mucosal irritation symptoms;

Secondary

MeasureTime frame
Iodine fading effect;

Countries

China

Contacts

Public ContactGuoxin Zhang

The First Affiliated Hospital to Nanjing Medical University

guoxinz@njmu.edu.cn+86 13951913128

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 1, 2026