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

Primary Purpose

Plaque Psoriasis

Status
Terminated
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
PSORI-CM01（YXBCM01） granule
placebo
Sponsored by
Guangdong Provincial Hospital of Traditional Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Plaque Psoriasis focused on measuring Stable Plaque Psoriasis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Chronic Disease Prevention and Control Station of Panyu District in Guangzhou
  • Guangdong Provincial Hospital of Traditional Chinese Medicine
  • The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

PSORI-CM01（YXBCM01）granule

PSORI-CM01（YXBCM01）granule low dose group

placebo

Arm Description

PSORI-CM01（YXBCM01）granule 1.1g os once a day for 12weeks.

PSORI-CM01（YXBCM01） granule 5.5g os once a day for 12weeks.

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

Outcomes

Primary Outcome Measures

PASI-50
The number of patients who achieve at least 50% improvement in PASI score from baseline.

Secondary Outcome Measures

PASI(Psoriasis Area and Severity Index)
The improvement in PASI score from baseline.
PASI-75
The number of patients who achieve at least 75% improvement in PASI score from baseline.
Pruritus Scores on the Visual Analogue Scale
BSA（Body Surface Area）
the Body Surface Area
DLQI（Dermatology Life Quality Index）
the Dermatology Quality Life Index
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.
Time interval for patients the first time to achieve PASI-50 from baseline
Relapse time interval
Relapse time interval refers to the time when patients who achieve PASI-50 for the first time until first relapse occurs.
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.

Full Information

First Posted
May 24, 2014
Last Updated
July 28, 2017
Sponsor
Guangdong Provincial Hospital of Traditional Chinese Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT02153840
Brief Title
Clinical Trial of PSORI-CM01（YXBCM01） Granule to Treat Stable Plaque Psoriasis
Official Title
A Double-blind, Randomized, Placebo-controlled Trial of PSORI-CM01（YXBCM01） Granule for Stable Plaque Psoriasis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Terminated
Why Stopped
Paitents were unwilling to be randomly assigned to a placebo group.
Study Start Date
December 2013 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guangdong Provincial Hospital of Traditional Chinese Medicine

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plaque Psoriasis
Keywords
Stable Plaque Psoriasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PSORI-CM01（YXBCM01）granule
Arm Type
Experimental
Arm Description
PSORI-CM01（YXBCM01）granule 1.1g os once a day for 12weeks.
Arm Title
PSORI-CM01（YXBCM01）granule low dose group
Arm Type
Experimental
Arm Description
PSORI-CM01（YXBCM01） granule 5.5g os once a day for 12weeks.
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Placebo granule 1.1g os once a day for 12weeks.
Intervention Type
Drug
Intervention Name(s)
PSORI-CM01（YXBCM01） granule
Other Intervention Name(s)
Chinese Hebal Medicine
Intervention Type
Drug
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
PASI-50
Description
The number of patients who achieve at least 50% improvement in PASI score from baseline.
Time Frame
12 weeks (plus or minus 3 days) after treatment
Secondary Outcome Measure Information:
Title
PASI(Psoriasis Area and Severity Index)
Description
The improvement in PASI score from baseline.
Time Frame
12 weeks (plus or minus 3 days) after treatment
Title
PASI-75
Description
The number of patients who achieve at least 75% improvement in PASI score from baseline.
Time Frame
12 weeks (plus or minus 3 days) after treatment
Title
Pruritus Scores on the Visual Analogue Scale
Time Frame
12 weeks (plus or minus 3 days) after treatment
Title
BSA（Body Surface Area）
Description
the Body Surface Area
Time Frame
12 weeks (plus or minus 3 days) after treatment
Title
DLQI（Dermatology Life Quality Index）
Description
the Dermatology Quality Life Index
Time Frame
12 weeks (plus or minus 3 days) after treatment
Title
Relapse rate in treatment period / follow-up period
Description
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 Frame
During the treatment period of 12 weeks / follow-up period of 12 weeks after treatment period
Title
Time interval for patients the first time to achieve PASI-50 from baseline
Time Frame
During the treatment period of 12 weeks
Title
Relapse time interval
Description
Relapse time interval refers to the time when patients who achieve PASI-50 for the first time until first relapse occurs.
Time Frame
During the treatment period of 12 weeks / follow-up period of 12 weeks after treatment period
Title
Rebound rate
Description
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.
Time Frame
During the treatment period of 12 weeks / follow-up period of 12 weeks after treatment period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Stable plaque psoriasis, duration > 1 year. Patients with Chinese medicine blood stasis syndrome. (2)18 to 65 years old, male or female patient. Mild psoriasis:3<PASI≤10, and BSA≤10%. Informed consent. Exclusion Criteria: Guttate psoriasis, inverse psoriasis or exclusively involves the face; Acute progression of psoriasis, and erythroderma tendency.Not blood stasis syndrome.Not stable psoriasis. Pregnant, lactating, or which one plan to become pregnant in a year; SAS（Self-rating Anxiety Scale）> 50 or SDS（Self-rating Depression Scale）> 53, or with other psychiatric disorders; 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. Allergic to any medicine or ingredients used in this study. Participating other clinical trials or participated within 1 month. 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. Patients need systemic treatment prescribed by doctors.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chuanjian Lu, Doctor
Organizational Affiliation
Guangdong Provincial Hospital of Traditional Chinese Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chronic Disease Prevention and Control Station of Panyu District in Guangzhou
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
Guangdong Provincial Hospital of Traditional Chinese Medicine
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine
City
Guangzhou
State/Province
Guangdong
Country
China

12. IPD Sharing Statement

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

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