Shuiniujiao Dihuang Decoction With Variation for the Treatment of Psoriasis

NCT ID: NCT05815797

Last Updated: 2024-02-28

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-31
• Study Completion Date: 2025-10-31

Brief 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.

Detailed Description

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. The major histological features of psoriasis include epidermal hyperplasia with aberrant keratinocyte differentiation, pronounced inflammatory cell infiltration and increased vascularization. Currently, pharmacological treatments such as retinoids, corticosteroids, and vitamin D analogs remain the main options for most psoriasis patients. However, the efficacy of conventional drugs is limited because of adverse side effects and the development of pharmacoresistance. Recently, biologics have become available for the treatment of acute and subacute plaque psoriasis with excellent response rate. However, the high costs involved with the biologics have barred many ordinary psoriasis patients from benefiting from this new class of anti-psoriatic medication.

Natural products are valuable sources in novel drug development. Shuiniujiao Dihuang Decoction with Variation (SDD) is an empirical formula of the Principal Investigator (Prof. Zhi-Xiu Lin), a highly experienced Registered Chinese Medicine Practitioner and Chinese medicine dermatologist working at the School of Chinese Medicine, The Chinese University of Hong Kong. SDD has been prescribed in clinic in Hong Kong for many years and observed to be effective in relieving psoriasis patients' clinical manifestations. SDD contains 23 Chinese herbal medicines, including Rehmanniae Radix (Dihuang), Bubali Cornu (Shuiniujiao), Paeoniae Radix Rubra (Chishao), Moutan Cortex (Mudanpi), Scrophulariae Radix (Xuanshen), Ophiopogonis Radix (Maidong), etc. The formula is composed of herbal medicines that can eliminate pathogenic heat, expel blood stasis and dampness, nourish yin, and have antipruritic effect.

A randomized, double-blinded, placebo-controlled trial will be conducted to evaluate the efficacy of SSD on psoriasis patients. Clinical evidence for the anti-psoriatic effects of SSD is a necessary step towards developing this Chinese medicine formula into an anti-psoriatic pharmaceutical agent.

Conditions

Psoriasis Vulgaris

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

SDD Formula

Subjects will receive SDD Formula granules (37g twice daily) for 12 weeks.

Group Type: EXPERIMENTAL

SDD formula

Intervention Type: DRUG

SDD formula consists of 23 herbal medicines

Placebo

Subjects will receive placebo granules (37g twice daily) for 12 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo

Interventions

SDD formula

SDD formula consists of 23 herbal medicines

Intervention Type: DRUG

Placebo

Placebo

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Prof. Lin Zhixiu

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zhixiu LIN, PhD

Role: PRINCIPAL_INVESTIGATOR

Hong Kong Institute of Integrative Medicine

Central Contacts

Zhixiu LIN, PhD

Role: CONTACT

linzx@cuhk.edu.hk

852-3943 6347

Tak Yee CHOW, MSc

Role: CONTACT

cmtychow@cuhk.edu.hk

852-2873 3075

Other Identifiers

CMDF Psoriasis Study

Identifier Type: -

Identifier Source: org_study_id