Plaque Psoriasis
Conditions
Keywords
Stable Plaque Psoriasis
Brief summary
The purpose of this study is to evaluate the efficacy and safety of Chinese herbal PSORI-CM01（YXBCM01） granule for stable plaque psoriasis, with blood stasis syndrome of Chinese Medicine.
Detailed description
Psoriasis is an immune-abnormal, chronic, proliferative skin disease characterized by scaly, erythematous patches and papules. An epidemiological survey found Chinese prevalence showed an upward trend in recent years. The disease has great influence on patients' appearance,health and quality of life. Some Chinese Herbal Medicine (CHM) therapies have shown long lasting therapeutic effect on controlling psoriasis vulgaris and with minimal side effects.CHM can alleviate the symptoms effectively,and reduce the recurrence rate of diseases. PSORI-CM01（YXBCM01）granule is one kind of CHM which is observed effective and safe to treat stable stable plaque psoriasis with blood stasis syndrome in clinical practice.
Interventions
DRUGPSORI-CM01（YXBCM01） granule
DRUGplacebo
Sponsors
Guangdong Provincial Hospital of Traditional Chinese Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Stable plaque psoriasis, duration \> 1 year. 2. Patients with Chinese medicine blood stasis syndrome. (2)18 to 65 years old, male or female patient. 3. Mild psoriasis:3\<PASI≤10, and BSA≤10%. 4. Informed consent.
Exclusion criteria
1. Guttate psoriasis, inverse psoriasis or exclusively involves the face; 2. Acute progression of psoriasis, and erythroderma tendency.Not blood stasis syndrome.Not stable psoriasis. 3. Pregnant, lactating, or which one plan to become pregnant in a year; 4. SAS（Self-rating Anxiety Scale）\> 50 or SDS（Self-rating Depression Scale）\> 53, or with other psychiatric disorders; 5. With history of cardiovascular, respiratory, digestive, urinary, and hematologic disease, which can't controlled through common treatment. Either with cancer, infection, electrolyte imbalance, acid-base disturbance and calcium metabolic disorder. 6. Allergic to any medicine or ingredients used in this study. 7. Participating other clinical trials or participated within 1 month. 8. Topical treatments (i.e. corticosteroids, 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 prescribed by doctors.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PASI-50 | 12 weeks (plus or minus 3 days) after treatment | The number of patients who achieve at least 50% improvement in PASI score from baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PASI-75 | 12 weeks (plus or minus 3 days) after treatment | The number of patients who achieve at least 75% improvement in PASI score from baseline. |
| Pruritus Scores on the Visual Analogue Scale | 12 weeks (plus or minus 3 days) after treatment | — |
| BSA（Body Surface Area） | 12 weeks (plus or minus 3 days) after treatment | the Body Surface Area |
| DLQI（Dermatology Life Quality Index） | 12 weeks (plus or minus 3 days) after treatment | the Dermatology Quality Life Index |
| PASI(Psoriasis Area and Severity Index) | 12 weeks (plus or minus 3 days) after treatment | The improvement in PASI score from baseline. |
| Time interval for patients the first time to achieve PASI-50 from baseline | During the treatment period of 12 weeks | — |
| Relapse time interval | During the treatment period of 12 weeks / follow-up period of 12 weeks after treatment period | Relapse time interval refers to the time when patients who achieve PASI-50 for the first time until first relapse occurs. |
| Rebound rate | During the treatment period of 12 weeks / follow-up period of 12 weeks after treatment period | Rebound can be defined only for patients who achieve PASI50，and occurs when the improvement in the PASI score increase up to 25% from the baseline PASI score. |
| Relapse rate in treatment period / follow-up period | During the treatment period of 12 weeks / follow-up period of 12 weeks after treatment period | Relapse can be defined only for patients who achieve PASI50，and occurs when the improvement in the PASI score falls below 50% from the baseline PASI score. |
Countries
China
Outcome results
None listed