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Shuiniujiao Dihuang Decoction With Variation for the Treatment of Psoriasis

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT05815797
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Chinese University of Hong Kong
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Zhixiu LIN, PhD
Principal Investigator Affiliation Hong Kong Institute of Integrative Medicine
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Not yet recruiting
Countries
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Psoriasis Vulgaris
Additional Details

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.

Arms & Interventions

Arms

Experimental: SDD Formula

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

Placebo Comparator: Placebo

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

Interventions

Drug: - SDD formula

SDD formula consists of 23 herbal medicines

Drug: - Placebo

Placebo

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Zhixiu LIN, PhD

linzx@cuhk.edu.hk

852-3943 6347

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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