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Dose optimization of thalidomide in the maintenance treatment for recurrent aphthous stomatitis: a multicenter randomized controlled trial.

Dose optimization of thalidomide in the maintenance treatment for recurrent aphthous stomatitis: a multicenter randomized controlled trial."

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400087537
Enrollment
Unknown
Registered
2024-07-30
Start date
2023-04-07
Completion date
Unknown
Last updated
2024-08-05

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

Conditions

Recurrent oral aphthous ulcer

Interventions

Experimental group:Take prednisone orally, 5mg/tablet, once a day in the morning, 3 tablets per time for a total of 7 days
Take 2 tablets once a day on the 8th, 9th, and 10th days, and take them orally once a day in the morning
Take one tablet once a day in the morning for the 11th, 12th, and 13th sessions. Take thalidomide orally, 25mg/tablet, taken half tablet every night before bedtime on the 8th to 13th day, and maintain
Control group:Take prednisone orally, 5mg/tablet, once a day in the morning, 3 tablets per time for a total of 7 days
Take one tablet once a day in the morning for the 11th, 12th, and 13th sessions. Take thalidomide orally, 25mg/tablet, taken one tablet every night before bedtime on the 8th to 13th day, and maintaine

Sponsors

Xinhua Hospital, Shanghai Jiaotong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) Based on medical history, clinical manifestations, and referring to the textbook "Oral Mucosal Disease" published by the People's Health Publishing House (5th edition), a patient with mild to moderate RAS was diagnosed; (2) Aged 18-70 years, regardless of gender; (3) Blood routine, liver function , and renal function are basically normal; (4) A history of RAS for over 12 months;RAS more than once a month; (5) The patient consent join and complete the trial , provide medical history, and attend reviews on time.

Exclusion criteria

Exclusion criteria: (1) Children, women planning pregnancy within a year, and men planning pregnancy within 6 months; (2) With severe systemic diseases or tumors; (3) Individuals allergic to the study medication or with an allergic disposition; (4) Heavy drinkers (over 15 units of alcohol per week) ; substance abusers.; (5) Used painkillers within 24 hours, antibiotics or anti-inflammatory drugs within a month, or systemic corticosteroids and immunosuppressants within 3 months; (6) Any mental illness or other conditions that legally restrict capacity; (7) Individuals with other identified oral mucosal diseases or periodontitis; (8) Autoimmune diseases like Behçet’s, peptic ulcers, anemia, Crohn’s disease, or acute infections; (9) With a low likelihood of inclusion (such as weak body, significantly overweight, etc.) (10) Has taken thalidomide medication currently and before screening

Design outcomes

Primary

MeasureTime frame
recurrence interval, RI;

Secondary

MeasureTime frame
visual analog scale, VAS;Number of ulcers;Treatment effectiveness rate;Adverse Effects Rate;

Countries

China

Contacts

Public ContactGuoyao Tang

Xinhua Hospital, Shanghai Jiaotong University School of Medicine

tanggy@shsmu.edu.cn+86 182 2106 6618

Outcome results

None listed

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