Shuiniujiao Dihuang Decoction With Variation for the Treatment of Psoriasis

NCT05815797 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: CMDF Psoriasis Study
• Study Type: interventional
• Target: 58
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Psoriasis Vulgaris

Outcome Measures

Primary Outcomes (2)

• Psoriasis Area and Severity Index (PASI)

  The change in Psoriasis Area and Severity Index (PASI) score will be assessed. PASI scores include area involved, erythema, induration and scaling. It will be scored on a scale of 0 to 4 (0, meaning none; 1, mild; 2, moderate; 3, severe; and 4, very severe). It will be performed by 2 blinded assessors who have been trained. Four main areas were assessed for calculation of the PASI scores: the head, the trunk, the upper extremities, and the lower extremities, corresponding to 10%,20%,30%, and 40% of the total body area, respectively. The maximum score for PASI is 72.

  Week 12

• Static Physician Global Assessment score (sPGA)

  Participants are requested to expose their skin thoroughly before the photographs are taken at each visit. The sPGA is an investigator-rated assessment of overall disease severity to be evaluated on a 5-point scale, where 0=clear and 4=severe. The severity of erythema, scaling, and plaque are considered for assessment. It will be performed by 2 blinded assessors who have received training.

  Week 12

Secondary Outcomes (25)

• Constitution in Chinese Medicine Questionnaire (Hong Kong Version)

  Week 12

• Chinese Medicine symptom pattern

  Week 6

• Chinese Medicine symptom pattern

  Week 12

• Chinese Medicine symptom pattern

  Week 18

• Psoriasis Area and Severity Index (PASI)

  Week 6

Study Arms (2)

SDD Formula

EXPERIMENTAL

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

Drug: SDD formula

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

SDD formula DRUG

SDD formula consists of 23 herbal medicines

SDD Formula

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Mild to moderate chronic plaque psoriasis (PASI score 3 to 12).
• Willingness to give informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Officials

• Zhixiu LIN, PhD

  Hong Kong Institute of Integrative Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhixiu LIN, PhD

CONTACT

852-3943 6347; linzx@cuhk.edu.hk

Tak Yee CHOW, MSc

CONTACT

852-2873 3075; cmtychow@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 21, 2023
• First Posted: April 18, 2023
• Study Start: May 1, 2024
• Primary Completion: April 1, 2025
• Study Completion: October 1, 2025
• Last Updated: February 28, 2024

Record last verified: 2024-02