Clinical trial NCT02153840: Clinical Trial of PSORI-CM01（YXBCM01） Granule to Treat Stable Plaque Psoriasis
Official title: A Double-blind, Randomized, Placebo-controlled Trial of PSORI-CM01（YXBCM01） Granule for Stable Plaque Psoriasis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Plaque Psoriasis
Keywords: Stable Plaque Psoriasis
Lead sponsor: Guangdong Provincial Hospital of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2014-06-03
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: PASI-50
timeFrame: 12 weeks (plus or minus 3 days) after treatment
Secondary outcomes:
measure: PASI(Psoriasis Area and Severity Index)
timeFrame: 12 weeks (plus or minus 3 days) after treatment
measure: PASI-75
timeFrame: 12 weeks (plus or minus 3 days) after treatment
measure: Pruritus Scores on the Visual Analogue Scale
timeFrame: 12 weeks (plus or minus 3 days) after treatment
measure: BSA（Body Surface Area）
timeFrame: 12 weeks (plus or minus 3 days) after treatment
measure: DLQI（Dermatology Life Quality Index）
timeFrame: 12 weeks (plus or minus 3 days) after treatment
measure: Relapse rate in treatment period / follow-up period
timeFrame: During the treatment period of 12 weeks / follow-up period of 12 weeks after treatment period
measure: Time interval for patients the first time to achieve PASI-50 from baseline
timeFrame: During the treatment period of 12 weeks
measure: Relapse time interval
timeFrame: During the treatment period of 12 weeks / follow-up period of 12 weeks after treatment period
measure: Rebound rate
timeFrame: During the treatment period of 12 weeks / follow-up period of 12 weeks after treatment period
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Chronic Disease Prevention and Control Station of Panyu District in Guangzhou
state: Guangdong
city: Guangzhou
country: China
facility: Guangdong Provincial Hospital of Traditional Chinese Medicine
state: Guangdong
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine
state: Guangdong
Study officials:
affiliation: Guangdong Provincial Hospital of Traditional Chinese Medicine
name: Chuanjian Lu, Doctor
role: PRINCIPAL_INVESTIGATOR
References: