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Table 1 Inclusion and exclusion criteria for Chinese herbal medicine regarding complications of topical therapy for psoriasis vulgaris (PV)

From: A statistical analysis plan for the efficiency and safety of Chinese herbal medicine used concurrently with topical therapy for psoriasis vulgaris

Inclusion

Patients with a clinical diagnosis of a psoriatic plaque (diagnosis of PV is compliant with guidelines of care for the management of psoriasis and psoriatic arthritis, 2008 [11, 10]) can be enrolled into this study if they:

1. Are ≥18 to ≤65 years of age

2. Have a PASI score >10 or body surface area (BSA) >10 %

3. Have a PASI score <30

4. Have a BSA <30 %

5. Have provided written informed consent from self or a legal surrogate

Exclusion

Patients are excluded from the study if any of the following criteria apply:

1. Presence of guttate psoriasis, inverse psoriasis or psoriasis exclusively involving the face

2. They are pregnant, lactating, or plan to become pregnant within a year

3. They have a Self-rating Anxiety Scale (SAS) score >50 or a Self-rating Depression Scale (SDS) score >53, or other psychiatric disorders

4. Have uncontrolled cardiovascular, respiratory, digestive, urinary, or hematological disease

5. They have known cancer, infection, electrolyte imbalance, acid-base disturbance, or calcium-related metabolic disorder

6. There is an abnormal serum calcium level (Ca2+ >2.9 mmol/L or <2 mmol/L)

7. They are allergic to any medicine or ingredients used in this study

8. They are currently enrolled in other clinical trials or participated in one within the previous 1 month

9. They have used topical treatments (i.e., corticosteroids, retinoic acid) within the previous 2 weeks; systemic therapy or phototherapy (ultraviolet B radiation, UVB) and psoralen (combined with ultraviolet A radiation, PUVA) within the previous 4 weeks; or biological therapy within the previous 12 weeks

10. They have acute progression of psoriasis and an erythrodermatitic tendency

11. They are patients who need systemic treatment prescribed by a physician

  1. PASI Psoriasis Area Severity Index