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

Sponsor
Guangdong Provincial Hospital of Traditional Chinese Medicine (Other)
Overall Status
Terminated
CT.gov ID
NCT02153840
Collaborator
(none)
35
3
3
22
11.7
0.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: PSORI-CM01(YXBCM01) granule
  • Drug: placebo
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
35 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Double-blind, Randomized, Placebo-controlled Trial of PSORI-CM01(YXBCM01) Granule for Stable Plaque Psoriasis
Study Start Date :
Dec 1, 2013
Actual Primary Completion Date :
Nov 1, 2014
Actual Study Completion Date :
Oct 1, 2015

Arms and Interventions

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: PSORI-CM01(YXBCM01) granule
    Other Names:
  • Chinese Hebal Medicine
  • Drug: placebo

    Placebo Comparator: placebo

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

    Drug: placebo

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. PASI(Psoriasis Area and Severity Index) [12 weeks (plus or minus 3 days) after treatment]

      The improvement in PASI score from baseline.

    2. 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.

    3. Pruritus Scores on the Visual Analogue Scale [12 weeks (plus or minus 3 days) after treatment]

    4. BSA(Body Surface Area) [12 weeks (plus or minus 3 days) after treatment]

      the Body Surface Area

    5. DLQI(Dermatology Life Quality Index) [12 weeks (plus or minus 3 days) after treatment]

      the Dermatology Quality Life Index

    6. 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.

    7. Time interval for patients the first time to achieve PASI-50 from baseline [During the treatment period of 12 weeks]

    8. 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.

    9. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Chronic Disease Prevention and Control Station of Panyu District in Guangzhou Guangzhou Guangdong China
    2 Guangdong Provincial Hospital of Traditional Chinese Medicine Guangzhou Guangdong China
    3 The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine Guangzhou Guangdong China

    Sponsors and Collaborators

    • Guangdong Provincial Hospital of Traditional Chinese Medicine

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Chuanjian Lu, Doctor, Guangdong Provincial Hospital of Traditional Chinese Medicine
    ClinicalTrials.gov Identifier:
    NCT02153840
    Other Study ID Numbers:
    • 201105
    First Posted:
    Jun 3, 2014
    Last Update Posted:
    Aug 1, 2017
    Last Verified:
    Jul 1, 2017
    Keywords provided by Chuanjian Lu, Doctor, Guangdong Provincial Hospital of Traditional Chinese Medicine
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 1, 2017