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

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

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.

Study Overview

• Status: Terminated
• Conditions: Plaque Psoriasis
• Intervention / Treatment: Drug: placebo; Drug: PSORI-CM01（YXBCM01） granule

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 Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • 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, China
      • Chronic Disease Prevention and Control Station of Panyu District in Guangzhou

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PSORI-CM01（YXBCM01）granule; PSORI-CM01（YXBCM01）granule 1.1g os once a day for 12weeks.	Drug: PSORI-CM01（YXBCM01） granule; Other Names: Chinese Hebal Medicine
Experimental: PSORI-CM01（YXBCM01）granule low dose group; PSORI-CM01（YXBCM01） granule 5.5g os once a day for 12weeks.	Drug: placebo; Drug: PSORI-CM01（YXBCM01） granule; Other Names: Chinese Hebal Medicine
Placebo Comparator: placebo; Placebo granule 1.1g os once a day for 12weeks.	Drug: placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
PASI(Psoriasis Area and Severity Index)	The improvement in PASI score from baseline.	12 weeks (plus or minus 3 days) after treatment
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
Pruritus Scores on the Visual Analogue Scale		12 weeks (plus or minus 3 days) after treatment
BSA（Body Surface Area）	the Body Surface Area	12 weeks (plus or minus 3 days) after treatment
DLQI（Dermatology Life Quality Index）	the Dermatology Quality Life Index	12 weeks (plus or minus 3 days) after treatment
Time interval for patients the first time to achieve PASI-50 from baseline		During the treatment period of 12 weeks
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
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

Collaborators and Investigators

• Sponsor: Guangdong Provincial Hospital of Traditional Chinese Medicine
• Investigators: Principal Investigator: Chuanjian Lu, Doctor, Guangdong Provincial Hospital of Traditional Chinese Medicine

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: May 24, 2014
• First Submitted That Met QC Criteria: May 31, 2014
• First Posted (Estimate): June 3, 2014

Study Record Updates

• Last Update Posted (Actual): August 1, 2017
• Last Update Submitted That Met QC Criteria: July 28, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: Stable Plaque Psoriasis
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: 201105