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Efficacy and Safety Study of Total Glucosides of Paeony Combined With Acitretin to Treat Psoriasis

Primary Purpose

Psoriasis

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Total glucosides of paeony & Acitretin Capsules
Acitretin Capsules
Sponsored by
Xijing Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis focused on measuring Total Glucosides of Paeony(TGP), Acitretin Capsules, Psoriasis Vulgaris

Eligibility Criteria

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

Inclusion Criteria:Meet the following conditions

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

Exclusion Criteria:One of the following is not included in this study:

  1. Pregnant women, ready to pregnant or lactating women;
  2. Known to root of herbaceous peony total glycosides (TGP) drug allergy;
  3. Have a serious heart, lung, kidney and other vital organs and endocrine system lesions and the history
  4. Patients is liver function abnormal persons (ALT above the center laboratory normal limit) or hepatitis b patient grain carriers;
  5. Need insulin control of diabetes; High blood pressure did not get good controller ;
  6. 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;
  7. Patients with chronic diarrhea, or peptic ulcer nearly 1 year;
  8. Patients suffering from malignant tumor;
  9. Patients suffering from acute and chronic infectious diseases;
  10. Mental disorders, history of alcohol abuse, drug or other substance abuse; 11. Other cases which researchers believe that can not enroll.

Sites / Locations

  • Xijing Hospitial

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Total glucosides of paeony & Acitretin Capsules

Acitretin Capsules

Arm Description

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

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

incidence of elevated Alanine aminotransferase
After 12 weeks treatment, relative to baseline,the incidence of elevated Alanine aminotransferase (ALT) was 6.8% in the experiment group and 22.2% in the control group (P<0.05).

Full Information

First Posted
January 8, 2014
Last Updated
July 11, 2014
Sponsor
Xijing Hospital
Collaborators
Henan Provincial People's Hospital, The First Affiliated Hospital of Dalian Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT02191020
Brief Title
Efficacy and Safety Study of Total Glucosides of Paeony Combined With Acitretin to Treat Psoriasis
Official Title
Multi-center, Randomized, Double Blind, Placebo Parallel-Controlled Study of the Efficacy and Safety of Total Glucosides of Paeony Combined With Acitretin Capsules to Treat Psoriasis Vulgaris
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Xijing Hospital
Collaborators
Henan Provincial People's Hospital, The First Affiliated Hospital of Dalian Medical University

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
Keywords
Total Glucosides of Paeony(TGP), Acitretin Capsules, Psoriasis Vulgaris

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
108 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Total glucosides of paeony & Acitretin Capsules
Arm Type
Experimental
Arm Description
During the first week，0.6g，oral，b.i.d.During the other weeks，0.6g，oral，t.i.d
Arm Title
Acitretin Capsules
Arm Type
Active Comparator
Arm Description
20mg/day oral,when subject's weight less than 70kg;otherwise,30mg/day oral.
Intervention Type
Drug
Intervention Name(s)
Total glucosides of paeony & Acitretin Capsules
Intervention Type
Drug
Intervention Name(s)
Acitretin Capsules
Primary Outcome Measure Information:
Title
Reduction in Psoriasis Area and Severity Index
Description
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).
Time Frame
week 0 and week 12
Secondary Outcome Measure Information:
Title
incidence of elevated Alanine aminotransferase
Description
After 12 weeks treatment, relative to baseline,the incidence of elevated Alanine aminotransferase (ALT) was 6.8% in the experiment group and 22.2% in the control group (P<0.05).
Time Frame
week 0 and week12

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:Meet the following conditions 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. Exclusion Criteria:One of the following is not included in this study: 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.
Facility Information:
Facility Name
Xijing Hospitial
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China

12. IPD Sharing Statement

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Efficacy and Safety Study of Total Glucosides of Paeony Combined With Acitretin to Treat Psoriasis

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