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Recruiting NCT05688488

Clinical Study of Curcumin in Preventing Postoperative Adhesion of Bilateral Vocal Cords

Phase I / Phase II Interventional Glottic Web of Larynx Laryngeal Stenosis Glottic Carcinoma Laryngeal Leucoplakia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Curcumin, Mitomycin-C.
Who it may be relevant to
Registry conditions: Glottic Web of Larynx, Laryngeal Stenosis, Glottic Carcinoma, Laryngeal Leucoplakia. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

To provide a novel therapy idea and method to solve the clinical problem of postoperative adhesion of bilateral vocal cords, patients enrolled in this study will be applied with curcumin on both wound sites of bilateral vocal cords after the surgery on the bilateral vocal cord endoscopically.

Interventions

  • Drug Curcumin
    Curcumin was applied to both wound sites of bilateral vocal cords. After evenly applied, gently massage the applied site for 3-5 minutes until the drug was fully absorbed.
  • Drug Mitomycin-C
    Mitomycin-C was applied to both wound sites of bilateral vocal cords. After evenly applied, gently massage the applied site for 3-5 minutes until the drug was fully absorbed.

Primary outcome measures

  • Number of participants with laryngeal web formation as assessed by videolaryngoscope [Time frame: 1 year postsurgery]

Eligibility criteria

Inclusion criteria

  • Patients with bilateral vocal cord diseases who are going to undergo resection of bilateral vocal cord lesions endoscopically.
  • Patients with bilateral vocal cord adhesion who are going to undergo incision of bilateral vocal cord adhesion endoscopically.

Exclusion criteria

  • Patients with other laryngeal diseases.
  • Patients with cardiac and pulmonary insufficiency.
  • Patients unable to cooperate with the follow-up on time after surgery.
  • Patients who refuse to sign the informed consent after notification.
  • Patients who have a severe allergic disease or allergic history to a variety of drugs.
  • Other circumstances that are not appropriate to be included in the clinical trial.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Prevention

Study locations

China · 1 center
  • Eye & ENT Hospital of Fudan University — Shanghai

Identifiers

NCT: NCT05688488 · 2022011-1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗