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

Not Applicable

Terminated

• Conditions: Plaque Psoriasis
• Interventions: Drug: PSORI-CM01（YXBCM01） granule; Drug: placebo

• Registration Number: NCT02153840
• Lead Sponsor: Guangdong Provincial Hospital of Traditional Chinese Medicine

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.

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2014-05-24
• Study First Submitted QC: 2014-05-31
• Study First Posted: 2014-06-03
• Primary Completion: 2014-11
• Study Completion: 2015-10
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-28
• Last Update Posted: 2017-08-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 35

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PSORI-CM01（YXBCM01）granule low dose group	PSORI-CM01（YXBCM01） granule	PSORI-CM01（YXBCM01） granule 5.5g os once a day for 12weeks.
PSORI-CM01（YXBCM01）granule low dose group	placebo	PSORI-CM01（YXBCM01） granule 5.5g os once a day for 12weeks.
placebo	placebo	Placebo granule 1.1g os once a day for 12weeks.
PSORI-CM01（YXBCM01）granule	PSORI-CM01（YXBCM01） granule	PSORI-CM01（YXBCM01）granule 1.1g os once a day for 12weeks.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
PASI(Psoriasis Area and Severity Index)	12 weeks (plus or minus 3 days) after treatment	The improvement in PASI score from baseline.
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.
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.
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
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.
Time interval for patients the first time to achieve PASI-50 from baseline	During the treatment period of 12 weeks
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.

Trial Locations

Locations (3)

The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine; 🇨🇳 Guangzhou, Guangdong, China

Guangdong Provincial Hospital of Traditional Chinese Medicine; 🇨🇳 Guangzhou, Guangdong, China

Chronic Disease Prevention and Control Station of Panyu District in Guangzhou; 🇨🇳 Guangzhou, Guangdong, China