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

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ClinicalTrials.gov Identifier: NCT02153840
Recruitment Status : Terminated (Paitents were unwilling to be randomly assigned to a placebo group.)
First Posted : June 3, 2014
Last Update Posted : August 1, 2017
Sponsor:
Information provided by (Responsible Party):
Chuanjian Lu, Guangdong Provincial Hospital of Traditional Chinese Medicine

Tracking Information
First Submitted Date  ICMJE May 24, 2014
First Posted Date  ICMJE June 3, 2014
Last Update Posted Date August 1, 2017
Study Start Date  ICMJE December 2013
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 31, 2014)
PASI-50 [ Time Frame: 12 weeks (plus or minus 3 days) after treatment ]
The number of patients who achieve at least 50% improvement in PASI score from baseline.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 31, 2014)
  • PASI(Psoriasis Area and Severity Index) [ Time Frame: 12 weeks (plus or minus 3 days) after treatment ]
    The improvement in PASI score from baseline.
  • PASI-75 [ Time Frame: 12 weeks (plus or minus 3 days) after treatment ]
    The number of patients who achieve at least 75% improvement in PASI score from baseline.
  • Pruritus Scores on the Visual Analogue Scale [ Time Frame: 12 weeks (plus or minus 3 days) after treatment ]
  • BSA(Body Surface Area) [ Time Frame: 12 weeks (plus or minus 3 days) after treatment ]
    the Body Surface Area
  • DLQI(Dermatology Life Quality Index) [ Time Frame: 12 weeks (plus or minus 3 days) after treatment ]
    the Dermatology Quality Life Index
  • Relapse rate in treatment period / follow-up period [ Time Frame: 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 [ Time Frame: During the treatment period of 12 weeks ]
  • Relapse time interval [ Time Frame: 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.
  • Rebound rate [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Trial of PSORI-CM01(YXBCM01) Granule to Treat Stable Plaque Psoriasis
Official Title  ICMJE A Double-blind, Randomized, Placebo-controlled Trial of PSORI-CM01(YXBCM01) Granule for Stable Plaque Psoriasis
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Plaque Psoriasis
Intervention  ICMJE
  • Drug: PSORI-CM01(YXBCM01) granule
    Other Name: Chinese Hebal Medicine
  • Drug: placebo
Study Arms  ICMJE
  • Experimental: PSORI-CM01(YXBCM01)granule
    PSORI-CM01(YXBCM01)granule 1.1g os once a day for 12weeks.
    Intervention: Drug: PSORI-CM01(YXBCM01) granule
  • Experimental: PSORI-CM01(YXBCM01)granule low dose group
    PSORI-CM01(YXBCM01) granule 5.5g os once a day for 12weeks.
    Interventions:
    • Drug: PSORI-CM01(YXBCM01) granule
    • Drug: placebo
  • Placebo Comparator: placebo
    Placebo granule 1.1g os once a day for 12weeks.
    Intervention: Drug: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: April 21, 2015)
35
Original Estimated Enrollment  ICMJE
 (submitted: May 31, 2014)
384
Actual Study Completion Date  ICMJE October 2015
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02153840
Other Study ID Numbers  ICMJE 201105
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Chuanjian Lu, Guangdong Provincial Hospital of Traditional Chinese Medicine
Study Sponsor  ICMJE Guangdong Provincial Hospital of Traditional Chinese Medicine
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Chuanjian Lu, Doctor Guangdong Provincial Hospital of Traditional Chinese Medicine
PRS Account Guangdong Provincial Hospital of Traditional Chinese Medicine
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP