psoriasis vulgaris
Conditions
Interventions
high dose PSORI-CM02 granule group:Subjects will be given high dose of PSORI-CM02 granule twice per day, and one pack each time after meal for twelve weeks
low dose PSORI-CM02 granule group:Subjects will be given low dose of PSORI-CM02 granule twice per day, and one pack each time after meal for twelve weeks
placebo group:Subjects will be given placebo twice per day, and one pack each time after meal for twelve weeks
Sponsors
Guangdong Provincial Hosptial of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Patients with stable psoriasis or plaque psoriasis more than one year; (2) Male or female patient aged between 18 to 65 years old; (3) 3<PASI<=12, meanwhile BSA<=10%; (4) Be able to provide signed informed consent.
Exclusion criteria
Exclusion criteria: (1) Most skin lesions as droplets, or psoriatic lesions can only be seen on face, scalp, nails, balanus, mucus and palmarplantar areas; (2) Acute progressive psoriasis, and erythroderma tendency; (3) Pregnant, lactating, or those who plan to become pregnant in a year; (4) SAS more than 50 or SDS more than 53, or with other psychiatric disorders; (5) With history of primary cardiovascular, respiratory, digestive, urinary, endocrinologic and hematologic diseases, which can't be controlled through ordinary treatments. Those who with malignant diseases, infections, electrolyte imbalance, acid-base disturbance. Patients with clinical test results listed below: AST or ALT 3 times more than normal upper limit; Creatinine 1.5 times more than normal upper limit; Hemoglobin elevates 20g/L more than normal upper limit; Platelet count less than 75.0*10^9/L; White blood cell less than 3.0*10^9/L; Or any other abnormal laboratory test results, assessed by investigators, that are not suitable for this clinical study; (6) Allergic to any medicine or ingredients used in this study; (7) Participating other clinical trials or participated within 1 month; (8) Topical treatments with corticosteroids or Retinoic acid within 2 weeks; systemic therapy or phototherapy (UVB and PUVA) within 4 weeks; biological therapy within 12 weeks; (9) Patients need systemic treatment with western medicine.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of subjects whose score in "Poriasis Area and Severity Index" have been improved by 50%;Improvement in score of Body Surface Area; | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement rate of scores in "Poriasis Area and Severity Index";Improvement in score of visual analogue scale; | — |
Countries
China
Contacts
Public ContactYan Yuhong
Guangdong Provincial Hosptial of Chinese Medicine
Outcome results
None listed