Shuiniujiao Dihuang Decoction With Variation for the Treatment of Psoriasis
ConditionPsoriasis Vulgaris
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorChinese University of Hong Kong
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Mild to moderate chronic plaque psoriasis (PASI score 3 to 12).
Willingness to give informed consent.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
SDD formula
DrugSDD formula consists of 23 herbal medicines
Placebo
DrugPlacebo
Treatment groups
58 Participants
are divided into 2 treatment groupsGroup A: SDD FormulaExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Week 122
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.
Time frame
Week 12Secondary outcomes
1
Constitution in Chinese Medicine Questionnaire (Hong Kong Version)
The 60-item Constitution in Chinese Medicine Questionnaire (CCMQ) Hong Kong version will be used to assess the body constitution (BC) in Chinese medicine of subjects. According to Chinese medicine theory, there are 9-type of BC: gentleness (8 Items), Qi-deficiency (8 Items), Yang-deficiency (7 Items), Yin-deficiency (8 Items), phlegm-wetness (8 Items), wetness-heat (6 Items), blood-stasis (7 Items), Qi-depression (7 Items), and special diathesis (7 Items). Subjects will have to score on a 5-point Likert scale for each item where 1=never and 5=for most of the time. A final score for each BC will be calculated according to the scoring algorithm. A higher score in the CCMQ BC scale indicates a higher likelihood of the specific BC type, and a score of 30 is set as threshold for case definition. Coexistence of multiple imbalanced BC types is possible which is consistent with the Chinese medicine theories.
Time frame
Week 122
Chinese Medicine symptom pattern
A structural designed record form will be completed by Chinese medicine practitioner (CMP) to record the signs and symptoms of the subjects, which includes but not limited to spirit, skin condition, joints condition, sleep condition, tongue and pulse condition. A final symptom pattern will be decided by the CMP according to the form by Chinese medicine theory.
Time frame
Week 63
Chinese Medicine symptom pattern
A structural designed record form will be completed by Chinese medicine practitioner (CMP) to record the signs and symptoms of the subjects, which includes but not limited to spirit, skin condition, joints condition, sleep condition, tongue and pulse condition. A final symptom pattern will be decided by the CMP according to the form by Chinese medicine theory.
Time frame
Week 124
Chinese Medicine symptom pattern
A structural designed record form will be completed by Chinese medicine practitioner (CMP) to record the signs and symptoms of the subjects, which includes but not limited to spirit, skin condition, joints condition, sleep condition, tongue and pulse condition. A final symptom pattern will be decided by the CMP according to the form by Chinese medicine theory.
Time frame
Week 18Sponsors and contacts
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Source ClinicalTrials.gov