vitiligo
Conditions
Interventions
Intervention group:Fangbai Granule
Control group:Placebo of Fangbai Granules
Sponsors
Chongqing Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Meeting the diagnostic criteria for stable non-segmental vitiligo; 2.Conforming to the syndrome differentiation criteria for liver-kidney deficiency pattern in traditional Chinese medicine (TCM); 3.The white macules achieving over 80% repigmentation as assessed by investigators, with an interval of no more than 6 months from the attainment of 80% repigmentation to study enrollment (for acral and hairy lesions, only stability is required, and repigmentation is not included in the evaluation); 4.Aged 18 to 65 years; 5.Voluntarily participating in the trial and signing the informed consent form (ICF).
Exclusion criteria
Exclusion criteria: Patients complicated with other skin disorders that may interfere with efficacy evaluation of the target disease; Pregnant or lactating females, as well as those planning to conceive within one year; Patients receiving oral glucocorticoids or immunosuppressants within the preceding 1 month, or topical preparations of such medications within the preceding 2 weeks; Subjects complicated with severe infection, malignant neoplasm, other autoimmune diseases, severe cardiovascular, hepatic or renal disorders and other critical systemic illnesses; Patients with known hypersensitivity to any study medication; Individuals requiring prolonged regular sun exposure; Patients deemed ineligible for enrollment upon investigator's clinical assessment; Subjects who decline to sign the informed consent form.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| recurrence rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| 12-month recurrence rate;Cell surface markers (CD3, CD4, CD8, CD45RO, CD62L, CD197, CD25, CD127);Cytokines (HMGN1, HMGN5, IL-15, CXCL9, CXCL10);VitiQol; | — |
Countries
China
Contacts
Public ContactLiu Yi
Chongqing hospital of traditional Chinese medicine
Outcome results
None listed