Clinical Trial of PSORI-CM01（YXBCM01） Granule to Treat St... | NCT02153840

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

NCT02153840

Sponsor

Guangdong Provincial Hospital of Traditional Chinese Medicine

Status

Terminated

Last Update Posted

Aug 1, 2017Actual

Enrollment

35Actual

Phase

Not Applicable

Conditions

Plaque Psoriasis

Interventions

PSORI-CM01（YXBCM01） granule
placebo

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2017

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Paitents were unwilling to be randomly assigned to a placebo group.

Expanded Access Info

Start Date

Dec 2013

Primary Completion Date

Nov 2014Actual

Completion Date

Oct 2015Actual

First Submitted Date

May 24, 2014

First Submission Date that Met QC Criteria

May 31, 2014

First Posted Date

Jun 3, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 28, 2017

Last Update Posted Date

Aug 1, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

35Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PSORI-CM01（YXBCM01）granule	Experimental	PSORI-CM01（YXBCM01）granule 1.1g os once a day for 12weeks.	Drug: PSORI-CM01（YXBCM01） granule
PSORI-CM01（YXBCM01）granule low dose group	Experimental	PSORI-CM01（YXBCM01） granule 5.5g os once a day for 12weeks.	Drug: PSORI-CM01（YXBCM01） granule Drug: placebo
placebo	Placebo Comparator	Placebo granule 1.1g os once a day for 12weeks.	Drug: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PSORI-CM01（YXBCM01） granule	Drug		PSORI-CM01（YXBCM01）granule PSORI-CM01（YXBCM01）granule low dose group	Chinese Hebal Medicine

Outcomes Module

Primary Outcomes

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 Outcomes

Measure	Description	Time Frame
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.

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Chuanjian Lu, Doctor	Guangdong Provincial Hospital of Traditional Chinese Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chronic Disease Prevention and Control Station of Panyu District in Guangzhou		Guangzhou	Guangdong		China