None listed
Conditions
Brief summary
Psoriasis currently has no cure. Whilst new therapies manage severe psoriasis well mild-moderate conditions have evidence of poor management. Chinese medicine regularly treats psoriasis successfully in a clinical scenario. This study will test a previously researched herbal formula and evaluate its efficacy when integrated with standard conventional therapy (calcipotriol). The study will randomize participants to either a herbal medicine plus calcipotriol group or a placebo plus calcipotriol group and compare changes in symptom severity, quality of life and blood markers for changes after 12 weeks of the intervention. It will also assess the safety of integrating the two therapies and acceptability of the treatment as well as assess any significant difference between health resource utilization of the two groups.
Interventions
ARM 1: Chinese herbal botanical granulated extract PSORI-CM01 (YXBCM01)
packaged as 5.5g per sachet and mixed with water administered orally twice daily for 12 weeks
- Calcipotriol 0.005% (50 microgram/g) cream, (30 g tubes)
administered daily to affected body surface areas for 12 weeks according to American Academy of Dermatology (AAD) guidelines (1% surface area coverage = 0.5 fingertip units)
Both interventions to commence together.
Adherence monitored via daily patient diary and weekly a
ARM 1: Chinese herbal botanical granulated extract PSORI-CM01 (YXBCM01) packaged as 5.5g per sachet and mixed with water administered orally twice daily for 12 weeks - Calcipotriol 0.005% (50 microgram/g) cream, (30 g tubes) administered daily to affected body surface areas for 12 weeks according to American Academy of Dermatology (AAD) guidelines (1% surface area coverage = 0.5 fingertip units) Both interventions to commence together. Adherence monitored via daily patient diary and weekly assessor consultation.
Sponsors
RMIT University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Outcome results
None listed