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NCT Number: NCT02191020

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Xijing Hospitial

Xi'an, Shaanxi, 710032, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Total glucosides of paeony & Acitretin Capsules

Drug

Acitretin Capsules

Drug

Primary outcomes

  1. Reduction in Psoriasis Area and Severity Index

    Time frame: week 0 and week 12

    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 outcomes

  1. incidence of elevated Alanine aminotransferase

    Time frame: week 0 and week12

    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).

Sponsors and collaborators

Lead sponsor

Xijing Hospital

Other

Collaborators

  • Henan Provincial People's Hospital
  • The First Affiliated Hospital of Dalian Medical University

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jul 15, 2014
Registry last updated
Jul 15, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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