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

Plaque Psoriasis Clinical Trial

Official title:

A Double-blind, Randomized, Placebo-controlled Trial of PSORI-CM01（YXBCM01） Granule for Stable Plaque Psoriasis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02153840
• Other study ID #: 201105
• Status: Terminated
• Phase: N/A
• First received: May 24, 2014
• Last updated: July 28, 2017
• Start date: December 2013
• Est. completion date: October 2015

Study information

• Verified date: July 2017
• Source: Guangdong Provincial Hospital of Traditional Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 35
• Est. completion date: October 2015
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Plaque Psoriasis
• Psoriasis

Intervention

Drug:
• PSORI-CM01(YXBCM01) granule

• placebo

Locations

Country	Name	City	State
China	Chronic Disease Prevention and Control Station of Panyu District in Guangzhou	Guangzhou	Guangdong
China	Guangdong Provincial Hospital of Traditional Chinese Medicine	Guangzhou	Guangdong
China	The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangdong Provincial Hospital of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PASI-50	The number of patients who achieve at least 50% improvement in PASI score from baseline.	12 weeks (plus or minus 3 days) after treatment
Secondary	PASI(Psoriasis Area and Severity Index)	The improvement in PASI score from baseline.	12 weeks (plus or minus 3 days) after treatment
Secondary	PASI-75	The number of patients who achieve at least 75% improvement in PASI score from baseline.	12 weeks (plus or minus 3 days) after treatment
Secondary	Pruritus Scores on the Visual Analogue Scale		12 weeks (plus or minus 3 days) after treatment
Secondary	BSA(Body Surface Area)	the Body Surface Area	12 weeks (plus or minus 3 days) after treatment
Secondary	DLQI(Dermatology Life Quality Index)	the Dermatology Quality Life Index	12 weeks (plus or minus 3 days) after treatment
Secondary	Relapse rate in treatment period / follow-up 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.	During the treatment period of 12 weeks / follow-up period of 12 weeks after treatment period
Secondary	Time interval for patients the first time to achieve PASI-50 from baseline		During the treatment period of 12 weeks
Secondary	Relapse time interval	Relapse time interval refers to the time when patients who achieve PASI-50 for the first time until first relapse occurs.	During the treatment period of 12 weeks / follow-up period of 12 weeks after treatment period
Secondary	Rebound rate	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.	During the treatment period of 12 weeks / follow-up period of 12 weeks after treatment period