Shuiniujiao Dihuang Decoction With Variation for the Treatment of Psoriasis (NCT05815797) | Clinical Trial Compass
RecruitingPhase 2
Shuiniujiao Dihuang Decoction With Variation for the Treatment of Psoriasis
Hong Kong58 participantsStarted 2024-06-11
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.