NCT02191020

Brief Summary

This is a randomized, double blind, placebo parallel-controlled, multi-center clinical trial. Patients with psoriasis vulgaris were randomly divided into the experiment group （treated with TGP combined with acitretin capsules) and control group （treated with placebo combined with acitretin capsules）.The treatment lasted 12 weeks. The efficacy and safety were evaluated at the baseline, as well as 2, 4, 8 and 12 weeks after the beginning of treatment.The investigator's hypothesis TGP combined with Acitretin Capsulesin is more safe and effective than Acitretin Capsulesin to treat Psoriasis Vulgaris.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 8, 2014

Completed
6 months until next milestone

First Posted

Study publicly available on registry

July 15, 2014

Completed
Last Updated

July 15, 2014

Status Verified

July 1, 2014

Enrollment Period

8 months

First QC Date

January 8, 2014

Last Update Submit

July 11, 2014

Conditions

Psoriasis

Keywords

Total Glucosides of Paeony(TGP)Acitretin CapsulesPsoriasis Vulgaris

Outcome Measures

Primary Outcomes (1)

  • Reduction in Psoriasis Area and Severity Index

    After 12 weeks treatment, relative to baseline, the proportion of patients achieving a 50% reduction in Psoriasis Area and Severity Index 50 (PASI50) was 90% in the experiment group and 70.5% in the control group (P\<0.05).

    week 0 and week 12

Secondary Outcomes (1)

  • incidence of elevated Alanine aminotransferase

    week 0 and week12

Study Arms (2)

Total glucosides of paeony & Acitretin Capsules

EXPERIMENTAL

During the first week，0.6g，oral，b.i.d.During the other weeks，0.6g，oral，t.i.d

Drug: Total glucosides of paeony & Acitretin Capsules

Acitretin Capsules

ACTIVE COMPARATOR

20mg/day oral,when subject's weight less than 70kg;otherwise,30mg/day oral.

Drug: Acitretin Capsules

Interventions

Total glucosides of paeony & Acitretin CapsulesDRUG
Total glucosides of paeony & Acitretin Capsules
Acitretin CapsulesDRUG
Acitretin Capsules

Eligibility Criteria

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

You may qualify if:

  • Diagnosed according to Classification criteria for Psoriasis vulgaris;
  • Patients aged 18 to 65 years (to the date of screening);
  • PASI grade\>7point\<20 point;
  • Not treatment in the Topical corticosteroids、Immunosuppresso、Biologicals agents or Tretinoin cream、Phototherapy nearly one months before enrolled.
  • Understanding the whole process of the study, voluntary participation and signed the informed consent;
  • Patient compliance is good, can guarantee in course of observation.

You may not qualify if:

  • Pregnant women, ready to pregnant or lactating women;
  • Known to root of herbaceous peony total glycosides (TGP) drug allergy;
  • Have a serious heart, lung, kidney and other vital organs and endocrine system lesions and the history
  • Patients is liver function abnormal persons (ALT above the center laboratory normal limit) or hepatitis b patient grain carriers;
  • Need insulin control of diabetes; High blood pressure did not get good controller ;
  • Patients with white blood cells \<4.0 × 109 / L, or a definite anemia (hemoglobin less than 100g / L), or platelets \<100 × 109 / L, or other blood disease;
  • Patients with chronic diarrhea, or peptic ulcer nearly 1 year;
  • Patients suffering from malignant tumor;
  • Patients suffering from acute and chronic infectious diseases;
  • Mental disorders, history of alcohol abuse, drug or other substance abuse; 11. Other cases which researchers believe that can not enroll.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xijing Hospitial

Xi'an, Shaanxi, 710032, China

Location

MeSH Terms

Conditions

Psoriasis

Interventions

Acitretin

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

RetinoidsCarotenoidsPolyenesAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsTerpenesPigments, BiologicalBiological Factors

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief in Department of Dermatology

Study Record Dates

First Submitted

January 8, 2014

First Posted

July 15, 2014

Study Start

February 1, 2013

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

July 15, 2014

Record last verified: 2014-07

Locations

CN(1)