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A randomized controlled study of photodynamic therapy combined with Xuefu Zhuyu capsule in the treatment of oral leukoplakia with Qi stagnation and blood stasis

A randomized controlled study of photodynamic therapy combined with Xuefu Zhuyu capsule in the treatment of oral leukoplakia with Qi stagnation and blood stasis

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100043326
Enrollment
Unknown
Registered
2021-02-10
Start date
2021-02-22
Completion date
Unknown
Last updated
2022-11-07

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

Conditions

Oral leukoplakia

Interventions

Sponsors

The Ninth People's Hospital Affiliated to Medical College of Shanghai Jiaotong University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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 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.

Design outcomes

Primary

MeasureTime frame
time to recurrence, TTR;Recurrence of parts;TCM clinical syndrome scores;

Countries

China

Contacts

Public ContactShen Xuemin

The Ninth People's Hospital Affiliated to Medical College of Shanghai Jiaotong University

kiyoshen@163.com+86 15821333957

Outcome results

None listed

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