A randomized controlled study of photodynamic therapy combined with Xuefu Zhuyu capsule in the treatment of oral leukoplakia with Qi stagnation and blood stasis
- Conditions
- Oral leukoplakia
- Registration Number
- ITMCTR2100004429
- Lead Sponsor
- The Ninth People's Hospital Affiliated to Medical College of Shanghai Jiaotong University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
1. Subjects aged 18-70 years.
2. Subjects of any gender.
3. Patients with oral leukoplakia diagnosed clinically and pathologically, and with epithelial dysplasia (leukoplakia stage III or above), TCM syndrome differentiation is consistent with qi stagnation and blood stasis syndrome.
4. Subjects without radiotherapy or chemotherapy.
5. Subjects whose general condition can tolerate the treatment plan.
6. The patients who read the informed consent form voluntarily participated in the project.
1. Pregnant or lactating women.
2. Patients with other oral mucosal diseases, tumors and psychosis.
3. Patients with poor general condition and intolerable treatment: the general condition was judged by the first routine examination, such as three routine examinations and blood biochemical examination, with HB < 60g / L and WBC < 3.0 x 10^9 /L, PLT < 80 x 10^9 / L and serum creatinine > 133 umol / L, it was considered that the general condition was poor and the treatment could not be carried out smoothly.
4. Subjects allergic to photosensitizer and Xuefu Zhuyu Capsule.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method TCM clinical syndrome scores;Recurrence of parts;TTR;
- Secondary Outcome Measures
Name Time Method