Clinical Trial of PSORI-CM01（YXBCM01） Granule to Treat Stable Plaque Psoriasis

Guangdong Provincial Hospital of Traditional Chinese Medicine

Status: Terminated

Conditions: Plaque Psoriasis

Treatments: Drug: placebo; Drug: PSORI-CM01（YXBCM01） granule

Study type: Interventional

Funder types: Other

Identifiers

NCT02153840

201105

Details and patient eligibility

About

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.

Full 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.

Enrollment: 35 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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35 participants in 3 patient groups, including a placebo group

PSORI-CM01（YXBCM01）granule

Experimental group

Description:

PSORI-CM01（YXBCM01）granule 1.1g os once a day for 12weeks.

Treatment:

Drug: PSORI-CM01（YXBCM01） granule

PSORI-CM01（YXBCM01）granule low dose group

Experimental group

Description:

PSORI-CM01（YXBCM01） granule 5.5g os once a day for 12weeks.

Treatment:

Drug: PSORI-CM01（YXBCM01） granule

Drug: placebo

placebo

Placebo Comparator group

Description:

Placebo granule 1.1g os once a day for 12weeks.

Treatment:

Drug: placebo