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

NCT ID: NCT05688488

Last Updated: 2023-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-05

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Glottic Web of Larynx Laryngeal Stenosis Glottic Carcinoma Laryngeal Leucoplakia Laryngeal Polyp Laryngeal Papilloma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Curcumin

Group Type EXPERIMENTAL

Curcumin

Intervention Type DRUG

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.

Mitomycin

Group Type ACTIVE_COMPARATOR

Mitomycin-C

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eye & ENT Hospital of Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Eye & ENT Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jian Chen, Ph.D

Role: CONTACT

+8621-64377134

Haitao Wu, Ph.D

Role: CONTACT

+8621-64377134

Facility Contacts

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Jian Chen

Role: primary

Other Identifiers

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2022011-1

Identifier Type: -

Identifier Source: org_study_id

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