Back to resultsClinical Study of Curcumin in Preventing Postoperative Adhesion of Bilateral Vocal Cords
Primary Purpose
Glottic Web of Larynx, Laryngeal Stenosis, Glottic Carcinoma
Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Curcumin
Mitomycin-C
Sponsored by
About this trial
This is an interventional prevention trial for Glottic Web of Larynx focused on measuring Curcumin
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.
Sites / Locations
- Eye & ENT Hospital of Fudan UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Curcumin
Mitomycin
Arm Description
Outcomes
Primary Outcome Measures
Number of participants with laryngeal web formation as assessed by videolaryngoscope
All participants received the videolaryngoscope every month post-surgery, and a laryngeal web is defined as a visible adhesion whose length reached 1 mm or greater.
Secondary Outcome Measures
Full Information
NCT ID
NCT05688488
First Posted
December 28, 2022
Last Updated
May 5, 2023
Sponsor
Eye & ENT Hospital of Fudan University
1. Study Identification
Unique Protocol Identification Number
NCT05688488
Brief Title
Clinical Study of Curcumin in Preventing Postoperative Adhesion of Bilateral Vocal Cords
Official Title
Clinical Study of Curcumin in Preventing Postoperative Adhesion of Bilateral Vocal Cords
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 5, 2023 (Anticipated)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eye & ENT Hospital of Fudan University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glottic Web of Larynx, Laryngeal Stenosis, Glottic Carcinoma, Laryngeal Leucoplakia, Laryngeal Polyp, Laryngeal Papilloma
Keywords
Curcumin
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Curcumin
Arm Type
Experimental
Arm Title
Mitomycin
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Curcumin
Intervention 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.
Intervention Type
Drug
Intervention Name(s)
Mitomycin-C
Intervention 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.
Primary Outcome Measure Information:
Title
Number of participants with laryngeal web formation as assessed by videolaryngoscope
Description
All participants received the videolaryngoscope every month post-surgery, and a laryngeal web is defined as a visible adhesion whose length reached 1 mm or greater.
Time Frame
1 year postsurgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jian Chen, Ph.D
Phone
+8621-64377134
Email
chenjent@qq.com
First Name & Middle Initial & Last Name or Official Title & Degree
Haitao Wu, Ph.D
Phone
+8621-64377134
Email
eentwuhaitao@163.com
Facility Information:
Facility Name
Eye & ENT Hospital of Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200031
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jian Chen
Email
chenjent@qq.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Clinical Study of Curcumin in Preventing Postoperative Adhesion of Bilateral Vocal Cords
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