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Trial Title:
Clinical Study of Curcumin in Preventing Postoperative Adhesion of Bilateral Vocal Cords
NCT ID:
NCT05688488
Condition:
Glottic Web of Larynx
Laryngeal Stenosis
Glottic Carcinoma
Laryngeal Leucoplakia
Laryngeal Polyp
Laryngeal Papilloma
Conditions: Official terms:
Papilloma
Leukoplakia
Laryngostenosis
Curcumin
Mitomycins
Mitomycin
Conditions: Keywords:
Curcumin
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
Curcumin
Description:
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.
Arm group label:
Curcumin
Intervention type:
Drug
Intervention name:
Mitomycin-C
Description:
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.
Arm group label:
Mitomycin
Summary:
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Patients with bilateral vocal cord diseases who are going to undergo resection of
bilateral vocal cord lesions endoscopically.
2. Patients with bilateral vocal cord adhesion who are going to undergo incision of
bilateral vocal cord adhesion endoscopically.
Exclusion Criteria:
1. Patients with other laryngeal diseases.
2. Patients with cardiac and pulmonary insufficiency.
3. Patients unable to cooperate with the follow-up on time after surgery.
4. Patients who refuse to sign the informed consent after notification.
5. Patients who have a severe allergic disease or allergic history to a variety of
drugs.
6. Other circumstances that are not appropriate to be included in the clinical trial.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Eye & ENT Hospital of Fudan University
Address:
City:
Shanghai
Zip:
200031
Country:
China
Status:
Recruiting
Contact:
Last name:
Jian Chen
Email:
chenjent@qq.com
Start date:
May 5, 2023
Completion date:
December 31, 2026
Lead sponsor:
Agency:
Eye & ENT Hospital of Fudan University
Agency class:
Other
Source:
Eye & ENT Hospital of Fudan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05688488
