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Long term efficacy and safety of thalidomide in the treatment of mild to moderate recurrent aphthous ulcer

Long term efficacy and safety of thalidomide in the treatment of mild to moderate recurrent aphthous ulcer

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000037257
Enrollment
Unknown
Registered
2020-08-27
Start date
2020-10-01
Completion date
Unknown
Last updated
2020-10-13

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

Conditions

Recurrent aphthous ulcer

Interventions

experimental group:Oral thalidomide for two months
control group:Nil

Sponsors

Xinhua Hospital Affiliated to Medical College of Shanghai Jiaotong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
37 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) According to the history and clinical manifestations, the patients were diagnosed as mild to moderate recurrent aphthous ulcer; (2) The age was 18-70 years old, with no gender limit; (3) Blood routine examination, liver function (alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, lactate dehydrogenase, total bilirubin, direct bilirubin), renal function (creatinine, urea nitrogen), electrolytes (k, Na, CL), blood glucose and coagulation were basically normal; (4) There were at least 2 recurrent aphthous ulcer cases with a history of more than 1 year, and oral ulcer occurred more than once a month. (December 2000, trial criteria for efficacy evaluation of recurrent aphthous ulcer) issued by oral mucosal disease Committee of Chinese Stomatological Association; (5) During the treatment, the patients did not receive any other drug treatment other than the scheme; (6) The patients participated voluntarily, signed informed consent and provided personal history. They could take part in the trial review on time and complete the whole research step.

Exclusion criteria

Exclusion criteria: (1) Women of childbearing age; (2) Patients with serious systemic diseases and tumors; (3) Those who are allergic to the drugs or allergic constitution in this study; (4) Alcohol addicts (drinking more than 15 units per week, each unit refers to 350ml beer or 150ml wine or 50ml spirits), smokers, drug abusers, drug abusers and smokers; (5) The subjects used analgesics within 24 hours, antibiotics and anti-inflammatory drugs within 1 month, glucocorticoids and immunosuppressants within 3 months; (6) Any mental illness, or any other illness that can lead to a legally recognized limitation of capacity; (7) Failure to follow the doctor's advice or incomplete records of the trial process affect the judgment of curative effect; (8) Patients with other confirmed oral mucosal diseases; patients with periodontitis; (9) Autoimmune diseases such as Behcet's disease, peptic ulcer, anemia, Crohn's disease, acute infectious diseases, etc; (10) According to the judgment of the researcher, those who are less likely to join the group (such as weak body, significantly overweight, etc.)

Design outcomes

Primary

MeasureTime frame
Intermittent period of ulcer attack ;

Countries

China

Contacts

Public ContactLin Ling

Department of Stomatology, Xinhua Hospital Affiliated to Medical College of Shanghai Jiaotong University

linyu4182003@126.com+86 13917645829

Outcome results

None listed

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