Shuiniujiao Dihuang Decoction With Variation for the Treatment of Psoriasis

• Status: Not yet recruiting
• Trial end date: 2025-10-01
• Target enrollment: 0
• Participant gender: All

Summary

Psoriasis is an inflammatory skin disease with huge negative impact on the quality of life of the patients, and has an overall prevalence of 2% to 3% in the general population. Plaques psoriasis is the most common type of the disease and presents red, well demarcated, and silvery plaques mainly localized in the umbilical and lumbosacral area as well as in the elbows, knees, and scalp.

Currently, pharmacological treatments such as retinoids, corticosteroids, vitamin D analogs and biologics remain the main options for most psoriasis patients. However, side effect and high cost barred many ordinary psoriasis patients from benefiting from the treatments.

A Chinese medicine formula "Shuiniujiao Dihuang Decoction with Variation (SDD)" was prescribed by Prof. Lin for many years and observed to be effective in relieving psoriasis patients' clinical manifestations.

In this study, subjects with psoriasis will be randomized into treatment group of "SDD" or placebo group for 12 weeks.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chinese University of Hong Kong

Criteria

Inclusion Criteria:

• Mild to moderate chronic plaque psoriasis (PASI score 3 to 12).

• Willingness to give informed consent.

Exclusion Criteria:

• Pustular or generalized erythrodermic psoriasis.

• Psoriatic arthritis with syndrome of spleen-kidney yang deficiency according to Chinese medicine theory.

• Systemic therapy for psoriasis 6 months prior to baseline.

• Use topical medications for psoriasis 14 days prior to baseline such as retinoids, corticosteroids, vitamin D analogues, tazarotene and tacrolimus.

• Has taken any antibiotics, probiotics and prebiotics 30 days prior to baseline.

• UV light therapy 30 days prior to baseline.

• Clinically significant laboratory abnormality in blood, liver or renal functions (≥1.5 times the upper limit of reference range).

• History of allergy to Chinese herbs.

• Known pregnant or lactation, or have a plan to conceive in 6 months.

• Known active gastric or duodenal ulcer, or severe arrhythmia.

• Unwillingness to comply with study protocol.

• Any other condition that in the opinion of the investigators could disadvantage the subject.