ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

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
Plaque Psoriasis Drug: PSORI-CM01(YXBCM01) granule Drug: placebo Not Applicable

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  (Clinical Trial)
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 : December 2013
Actual Primary Completion Date : November 2014
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

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 Name: 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 Name: Chinese Hebal Medicine

Drug: placebo
Placebo Comparator: placebo
Placebo granule 1.1g os once a day for 12weeks.
Drug: placebo



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. PASI(Psoriasis Area and Severity Index) [ Time Frame: 12 weeks (plus or minus 3 days) after treatment ]
    The improvement in PASI score from baseline.

  2. 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.

  3. Pruritus Scores on the Visual Analogue Scale [ Time Frame: 12 weeks (plus or minus 3 days) after treatment ]
  4. BSA(Body Surface Area) [ Time Frame: 12 weeks (plus or minus 3 days) after treatment ]
    the Body Surface Area

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

  6. 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.

  7. Time interval for patients the first time to achieve PASI-50 from baseline [ Time Frame: During the treatment period of 12 weeks ]
  8. 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.

  9. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02153840


Locations
China, Guangdong
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, China
Sponsors and Collaborators
Guangdong Provincial Hospital of Traditional Chinese Medicine
Investigators
Principal Investigator: Chuanjian Lu, Doctor Guangdong Provincial Hospital of Traditional Chinese Medicine

Responsible Party: Chuanjian Lu, Doctor, Guangdong Provincial Hospital of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT02153840     History of Changes
Other Study ID Numbers: 201105
First Posted: June 3, 2014    Key Record Dates
Last Update Posted: August 1, 2017
Last Verified: July 2017

Keywords provided by Chuanjian Lu, Guangdong Provincial Hospital of Traditional Chinese Medicine:
Stable Plaque Psoriasis

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases