Integrative medicine for plaque psoriasis combining Chinese herbal medicine with conventional therapy.

Phase 2

Completed

• Conditions: Plaque psoriasis (psoriasis vulgaris); Alternative and Complementary Medicine - Herbal remedies; Skin - Dermatological conditions; Inflammatory and Immune System - Other inflammatory or immune system disorders

• Registration Number: ACTRN12614000493640
• Lead Sponsor: RMIT University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-05-12
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1 People aged between 18 years and 70 years;
2 People with at least 12 months history of psoriasis vulgaris symptoms diagnosed by physician and where calcipotriol would be appropriate treatment
3 Patient informed consent

Exclusion Criteria

1 Pregnant or breast feeding females;
2 Type of psoriasis other than vulgaris;
3 PASI score >12 or <7
4 Patients taking systemic drugs or phototherapy for psoriasis within 4 weeks prior to screening;
5 Taking topical drug treatment for psoriasis within 2 weeks prior to screening
6 Other severe disorders;
7 Known disorders of calcium metabolism (high blood calcium levels);
7 Known kidney function disorders.
8 Taking calcium, vitamin D supplements or vitamin D-like medicines.
9 Known sensitivity to Chinese herbs.
10 Known sensitivity to calcipotriol
11 Unwilling/unable to cease other topical and systemic psoriasis related medication use for the duration of the trial.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
change in Psoriasis Area Severity Index (PASI) score (%)[12 weeks and 24 weeks];quality of life improvement change in Dermatology Life Quality Index (DLQI) score (%)[12 weeks and 24 weeks];quality of life improvement change in SKINDEX 29 score[12 weeks and 24 weeks]

Secondary Outcome Measures

Name	Time	Method
adverse effects.<br>nausea, diarrhoea, abdominal pain assessed by patient report at assessments.[12 weeks and 24 weeks];relapse rate (defined as return of the rash to 50% of the area it involved before treatment)[24 weeks];Acceptability of treatment (measured on an ordinal scale from 0-10 where 0 equals very dissatisfied with the treatment and 10 equals very satisfied with the treatment) and willingness to repeat (measured at each assessment period on a Likert scale with a choice of response; Definitely No, Probably No, Probably yes, Definitely yes and Unsure)[12 and 24 weeks];Body Surface Area (BSA) score[12 weeks and 24 weeks];Blood test (Kidney and liver function as well as analysis of key psoriasis specific cytokine changes)[12 and 24 weeks];Health resource utilisation data (participant reported GP visits, hospital visits and use of medication)[12 weeks and 24 weeks]