Effectiveness and Safety of Tripterygium Wilfordii Tablets in the Treatment of Vocal Cord Leukoplakia

Clinical Research Project of the Second Hospital of Tianjin Medical University in 2019

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR1900025914

Enrollment

Unknown

Registered

2019-09-14

Start date

2020-07-01

Completion date

Unknown

Last updated

2019-09-16

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

Conditions

Vocal cord leukoplakia

Interventions

Experimental group of flat patchy pattern:Tripterygium Wilfordii Tablets

Control group of flat patchy pattern:Placebo of Tripterygium Wilfordii Tablets

Experimental group of Uplift thickening type:Tripterygium Wilfordii Tablets

Control group of Uplift thickening type:Placebo of Tripterygium Wilfordii Tablets

Experiment group of uplift bulge type:Tripterygium Wilfordii Tablets

Control group of uplift bulge type:Placebo of Tripterygium Wilfordii Tablets

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Patients with vocal cord leukoplakia who have been clearly examined by electronic laryngoscopy meet the diagnostic criteria of vocal cord leukoplakia and meet the following requirements. Aged >=18 years old.

Exclusion criteria

Exclusion criteria: (1) Patients with vocal cord polyps, nodules and cysts; (2) Patients with Laryngeal Malignant Tumors; (3) Patients with acute laryngitis; (4) Child patients; (5) Requirers of childbearing age; (6) Pregnant and lactating women; (7) Cardiac insufficiency; (8) Severe arrhythmia; (9) Liver insufficiency; (10) Severe anemia, leukopenia and thrombocytopenia; (11) Patients with active gastroduodenal ulcer; (12) Renal insufficiency; (13) Patients with cirrhosis of the liver; (14) Patients with chronic hepatitis; (15) Maintenance dialysis, functional kidney transplantation or planned living donor transplantation; (16) Patients with polycystic kidney disease; (17) Patients with ketoacidosis in the past five years; (18) Symptomatic hypotension, or screening of patients with systolic blood pressure 180 mmHg; (19) Patients with ALT or AST levels greater than 3 times the normal high value at screening; (20) Patients allergic to Tripterygium wilfordii; (21) Within the past three months or less. Immunosuppressive therapy, including prednisolone 10 mg or equivalent dose, was used. Or any subject or equivalent dosage who is receiving prednisone greater than 10 mg; (22) Users of research drugs within 30 days prior to housing; (23) Poor compliance with clinical follow-up or medication.

Design outcomes

Primary

Measure	Time frame
The area of vocal cord leukoplakia;	—

Secondary

Measure	Time frame
Jita number;	—

Countries

China

Contacts

Public ContactNiu Juntao

The Second Hospital of Tianjin Medical University

niuniunihao@126.com+86 18902055062

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026