Psoriasis VulgarisPhase 2NCT05815797
Shuiniujiao Dihuang Decoction With Variation for the Treatment of Psoriasis
A Phase 2 study testing SDD formula in people with Psoriasis Vulgaris, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Psoriasis Vulgaris
- What is being tested?
- SDD formula
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteHong Kong
- Study dates
- 11 Jun 2024to Oct 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mild to moderate chronic plaque psoriasis (PASI score 3 to 12).
- Willingness to give informed consent.
Who cannot join
- 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.
Show all 12Show fewer
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
Hong Kong Institute of Integrative Medicine
Hong Kong
Prof. Lin, 852-28733252, linzx@cuhk.edu.hk
About this study
Official title: The Safety and Effects of Using Shuiniujiao Dihuang Decoction With Variation for the Treatment of Psoriasis: A Double-blind, Randomized, Placebo-Controlled 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.
Read more
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.
Read the 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
- Being tested
- SDD formula, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SDD formulaDrug
SDD formula consists of 23 herbal medicines
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| SDD Formula | Experimental | Subjects will receive SDD Formula granules (37g twice daily) for 12 weeks. Receives: Drug: SDD formula |
| Placebo | Placebo comparator | Subjects will receive placebo granules (37g twice daily) for 12 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Week 12
Secondary outcomes (25)
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.
Measured: Week 12
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.
Measured: Week 6
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.
Measured: Week 12
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.
Measured: Week 18
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.
Measured: Week 6
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.
Measured: Week 18
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.
Measured: Week 6
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.
Measured: Week 18
Psoriasis-involved body surface area (BSA)
BSA represents the affected skin surface. It is an objective measure of psoriasis severity. The head, the upper extremities, the trunk, and the lower extremities, corresponding to 10%,20%,30%, and 40% of the total body area, respectively. The range of BSA is 0-100. It will be performed by 2 blinded assessors who have received training by Dr Steven Loo.
Measured: Week 6
Psoriasis-involved body surface area (BSA)
BSA represents the affected skin surface. It is an objective measure of psoriasis severity. The head, the upper extremities, the trunk, and the lower extremities, corresponding to 10%,20%,30%, and 40% of the total body area, respectively. The range of BSA is 0-100. It will be performed by 2 blinded assessors who have received training by Dr Steven Loo.
Measured: Week 12
Psoriasis-involved body surface area (BSA)
BSA represents the affected skin surface. It is an objective measure of psoriasis severity. The head, the upper extremities, the trunk, and the lower extremities, corresponding to 10%,20%,30%, and 40% of the total body area, respectively. The range of BSA is 0-100. It will be performed by 2 blinded assessors who have received training by Dr Steven Loo.
Measured: Week 18
Impact of Psoriasis Questionnaire (IPSO)
The change in Impact of Psoriasis Questionnaire (IPSO) score will be assessed. IPSO is a validated 16-item psoriasis-specific instrument for quality of life of psoriasis patients. The IPSO is intended predominantly to assess the psychosocial impact of psoriasis on patient's lives. The IPSO uses an ordinal rating scale, with responses of 'none', 'some', 'moderately', 'quite a bit' and 'extremely' scored 1, 2, 3, 4 and 5, respectively. The scores for item 4 were reversed. The higher the summed score, the greater the impact experienced due to psoriasis.
Measured: Week 12
Short Form 36 survey (SF36)
The change in the score of quality of life using Short Form 36 survey (SF36) will be assessed. SF36 is generic instrument to measure general health status that is complementary to those derived from dermatological questionnaires. It will be used to assess the patient's health status using 8 different dimensions including vitality, physical functioning, bodily pain, general health perceptions, role limitations due to physical health, role limitations due to emotional health, social role functioning and mental health. The possible score ranges from 0 to 100 points whereby 0 points represent the greatest possible limitation of health, while 100 points represent the absence of health restrictions.
Measured: Week 12
Psoriasis Itch Visual Analog Scale (Itch VAS)
Psoriasis itch VAS is a validated tool to assess treatment benefit of plaque psoriasis. It was developed to measure itch intensity within the last 24 hours. A horizontal line with a length of 100mm is to be used to represented the range of itch intensity from 0 (no itch at all) to 100 (worst itch you can imagine). Subjects rated the maximal intensity of itch during the previous 24 hours by putting a vertical mark through the horizontal line at the the spot he/she felt best reflected their maximal itch intensity.
Measured: Week 12
Use of rescue therapy
The frequent use of rescue therapy during study period
Measured: Day 0 to Week 18
Adverse events
Adverse events related to study treatment
Measured: Day 0 to Week 18
Serum markers (IL-17, IL-22)
The changes in levels of serum markers IL-17, IL-22
Measured: Week 6
Serum markers (CRP )
The changes in levels of serum markers C-reactive protein (CRP)
Measured: Week 6
Serum markes (BD2)
The changes in levels of serum marker Beta-Defensin 2 (BD2).
Measured: Week 6
Serum markers (IL-17, IL-22)
The changes in levels of serum markers IL-17, IL-22
Measured: Week 12
Serum markers (CRP)
The changes in levels of serum markers C-reactive protein (CRP)
Measured: Week 12
Serum markers (BD2)
The changes in levels of serum marker Beta-Defensin 2 (BD2).
Measured: Week 12
Oral and Gut microbiota composition in saliva and stools
Saliva and stool specimen will be collected at baseline and week 12 (+/-4 days) for gut microbiota assessments.
Measured: Week 12
Gene expression of serum inflammatory factors
The changes in gene expression of serum inflammatory factors will be assessed by using the blood sample taken on baseline, week 6 and week 12. Analysis of such item could help to explore the effect mechanism of investigating medicinal product on gene expression of serum inflammatory factors on psoriasis patients.
Measured: Week 6
Gene expression of serum inflammatory factors
The changes in gene expression of serum inflammatory factors will be assessed by using the blood sample taken on baseline, week 6 and week 12. Analysis of such item could help to explore the effect mechanism of investigating medicinal product on gene expression of serum inflammatory factors on psoriasis patients.
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start11 Jun 2024
- Primary completionApr 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriasis VulgarisStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Lin Zhixiu, Chinese University of Hong Kong
- Investigators
- Zhixiu LIN, PhD, Principal investigator, Hong Kong Institute of Integrative Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05815797
- Sponsor's protocol ID
- CMDF Psoriasis Study
- Status last verified
- Jul 2026
- First submitted
- 21 Feb 2023
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Effects of Using Shuiniujiao Dihuang Decoction With Variation for the Treatment of Psoriasis: A Double-blind, Randomized, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT05815797
- Acronym / sponsor ID
- CMDF Psoriasis Study
- Conditions
- Psoriasis Vulgaris
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 11 Jun 2024 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 18 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SDD Formula | Experimental | Drug: SDD formulaSubjects will receive SDD Formula granules (37g twice daily) for 12 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboSubjects will receive placebo granules (37g twice daily) for 12 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Mild to moderate chronic plaque psoriasis (PASI score 3 to 12).
- Willingness to give informed consent.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SDD formulaSDD formula consists of 23 herbal medicines | Drug | SDD Formula |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Psoriasis Area and Severity Index (PASI)
Time frame: Week 12
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.
Static Physician Global Assessment score (sPGA)
Time frame: Week 12
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.
25 secondary outcomes
Constitution in Chinese Medicine Questionnaire (Hong Kong Version)
Time frame: Week 12
Chinese Medicine symptom pattern
Time frame: Week 6
Chinese Medicine symptom pattern
Time frame: Week 12
Chinese Medicine symptom pattern
Time frame: Week 18
Psoriasis Area and Severity Index (PASI)
Time frame: Week 6
Psoriasis Area and Severity Index (PASI)
Time frame: Week 18
Static Physician Global Assessment score (sPGA)
Time frame: Week 6
Static Physician Global Assessment score (sPGA)
Time frame: Week 18
Psoriasis-involved body surface area (BSA)
Time frame: Week 6
Psoriasis-involved body surface area (BSA)
Time frame: Week 12
Psoriasis-involved body surface area (BSA)
Time frame: Week 18
Impact of Psoriasis Questionnaire (IPSO)
Time frame: Week 12
Short Form 36 survey (SF36)
Time frame: Week 12
Psoriasis Itch Visual Analog Scale (Itch VAS)
Time frame: Week 12
Use of rescue therapy
Time frame: Day 0 to Week 18
Adverse events
Time frame: Day 0 to Week 18
Serum markers (IL-17, IL-22)
Time frame: Week 6
Serum markers (CRP )
Time frame: Week 6
Serum markes (BD2)
Time frame: Week 6
Serum markers (IL-17, IL-22)
Time frame: Week 12
Serum markers (CRP)
Time frame: Week 12
Serum markers (BD2)
Time frame: Week 12
Oral and Gut microbiota composition in saliva and stools
Time frame: Week 12
Gene expression of serum inflammatory factors
Time frame: Week 6
Gene expression of serum inflammatory factors
Time frame: Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zhixiu LIN, PhD principal investigator
Hong Kong Institute of Integrative Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SDD formula in people with Psoriasis Vulgaris, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhixiu LIN, PhD (852-3943 6347, linzx@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psoriasis Area and Severity Index (PASI) (time frame: Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.