NCT02153840

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2013

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 24, 2014

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 3, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

August 1, 2017

Status Verified

July 1, 2017

Enrollment Period

11 months

First QC Date

May 24, 2014

Last Update Submit

July 28, 2017

Conditions

Plaque Psoriasis

Keywords

Stable Plaque Psoriasis

Outcome Measures

Primary Outcomes (1)

  • 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 (9)

  • PASI(Psoriasis Area and Severity Index)

    12 weeks (plus or minus 3 days) after treatment

  • PASI-75

    12 weeks (plus or minus 3 days) after treatment

  • Pruritus Scores on the Visual Analogue Scale

    12 weeks (plus or minus 3 days) after treatment

  • BSA（Body Surface Area）

    12 weeks (plus or minus 3 days) after treatment

  • DLQI（Dermatology Life Quality Index）

    12 weeks (plus or minus 3 days) after treatment

  • +4 more secondary outcomes

Study Arms (3)

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） granuleDrug: placebo

placebo

PLACEBO COMPARATOR

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

Drug: placebo

Interventions

PSORI-CM01（YXBCM01） granuleDRUG
Also known as: Chinese Hebal Medicine
PSORI-CM01（YXBCM01）granulePSORI-CM01（YXBCM01）granule low dose group
placeboDRUG
PSORI-CM01（YXBCM01）granule low dose groupplacebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Chronic Disease Prevention and Control Station of Panyu District in Guangzhou

Guangzhou, Guangdong, China

Location

Guangdong Provincial Hospital of Traditional Chinese Medicine

Guangzhou, Guangdong, China

Location

The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine

Guangzhou, Guangdong, China

Location

Study Officials

  • Chuanjian Lu, Doctor

    Guangdong Provincial Hospital of Traditional Chinese Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

May 24, 2014

First Posted

June 3, 2014

Study Start

December 1, 2013

Primary Completion

November 1, 2014

Study Completion

October 1, 2015

Last Updated

August 1, 2017

Record last verified: 2017-07

Locations

CN(3)