PsoriasisPhase 2NCT04117919
Psoriasis、Indigo Naturalis、Chinese Medicine Medicated Bath
A Phase 2 study testing paper mulberry leaf and Triamcinolone (Encort-A) 0.1%15g/Tube in people with Psoriasis, run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
Psoriasis is a chronic inflammatory skin disease. Plague-type psoriasis is the most common form of the disease, occurring in more than 80% of the cases. This type of psoriasis is characterized by sharply dermatcated, erythematous, scaling plagues that typically affect the elbows, knees, scalp, and trunk. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Psoriasis
- What is being tested?
- paper mulberry leaf and Triamcinolone (Encort-A) 0.1%15g/Tube
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 5 Oct 2019to 3 Mar 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 20-65 years,
- had a diagnosis of plaque-type psoriasis for ≥6 months,
- a Physician's Global Assessment (PGA) score of 2-3, <20% total body surface area (BSA) involvement, and a target plaque of ≥4 cm2.
Who cannot join
- non-plaque psoriasis,
- rebound/flare of chronic psoriasis,
- history of psoriatic arthritis,
- current drug-induced psoriasis,
- pregnant/nursing/planning pregnancy (men and women),
- used biologics within 3 months or 5 times the half-life,
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- received phototherapy/systemic treatment within 4 weeks,
- topicals within 2 weeks,
- any systemic immunosuppressants within 4 weeks, -lithium/antimalarial/intramuscular gold within 4 weeks,
- tested positive for HIV/hepatitis B/C,
- had a history of alcohol/drug abuse,
- clinically-significant laboratory abnormality,
- sensitivity to Chinese herbs ,or allergy to leaf of paper mulberry.
- had skin wound or skin infection
- had current signs/symptoms of severe, progressive, or uncontrolled medical conditions, or were participating concurrently in an investigational study.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
No. 91, Xueshi Rd., North Dist., Taichung City 404, Taiwan (R.O.C.)
Taichung
Hui-Man Cheng
About this study
Official title: Pilot Study of Chinese Medicine Medicated Bath as Complementary Medicine for Mild to Moderate Plaque -Type Psoriasis Patient.
Psoriasis is a chronic inflammatory skin disease. Plague-type psoriasis is the most common form of the disease, occurring in more than 80% of the cases. This type of psoriasis is characterized by sharply dermatcated, erythematous, scaling plagues that typically affect the elbows, knees, scalp, and trunk. Estimates of the prevalence of psoriasis was vary from 0.5% to 4.6%, with rate varying between countries and races. The prevalence of psoriasis was about 2% in Taiwan. The etiology of psoriasis remains unknown; however, current research mostly indicated that psoriasis was caused by multiple factors, and it was highly related to Th-17 immunal pathway.Treatment of psoriasis included topical therapy, phototherapy and systemic therapy. Although beneficial, those therapies often caused undesirable adverse effects. Traditional Chinese medicine is one of the most fuguently chosen alternative therapies in China and Taiwan, and psoriasis has been treated for centuries with topical and oral herbal prepations. Chinese medicine medicated bath is a characteristic therapy of Traditional Chinese medicine. It combines both hot bath and herbs to enhance absorption of the effective ingredients of herb. There were reports about the application of Chinese medicine medicated bath to treat psoriasis patients in China. We also used Chinese medicine medicated bath (Jing-Fu-Yau-Yu-Bau) as a complementary therapy of psoriasis patients for a long time in China Medical University Hospital. The patient felt well after using Jing-Fu-Yau-Yu-Bau. The component of Jing-Fu-Yau-Yu-Bau is paper mulberry leaf. The botanical origin of paper mulberry leaf is Broussonetia papyrifera (L.) Vent. It can clear heat, cool blood and relieve itching. Based on the 83 journal paper we searched on PubMed, there had been extracted a great deal of phenolics, terpenes and flavonoids from paper mulberry leaf that had antibacterial, antifungal, antioxidant and antineoplastic effects.
This is a single site, randomized, single-blind, controlled pilot study of Jing- Fu-Yau-Yu-Bau as a complementary therapy to treat mild to moderate plaque- type psoriasis during an 8-week period. We estimate to enroll 30 subjects (treatment group(N=15); controlled group(N=15)). We plan to investigate the efficacy and safety of Jing-Fu-Yau-Yu-Bau in Chinese subjects with mild to moderate plaque-type psoriasis.
Read the detailed description
This is a single site, randomized, single-blind, controlled pilot study of Jing- Fu-Yau-Yu-Bau as a complementary therapy to treat mild to moderate plaque- type psoriasis during an 8-week period. We estimate to enroll 30 subjects (treatment group(N=15); controlled group(N=15)).
- Conditions
- Psoriasis
- Being tested
- paper mulberry leaf, Triamcinolone (Encort-A) 0.1%15g/Tube
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paper mulberry leafDrug
Also called Triamcinolone (Encort-A) 0.1%15g/Tube, Encort-A
Topical steroids+paper mulberry leaf The botanical origin of paper mulberry leaf is Broussonetia papyrifera (L.) Vent.
Triamcinolone (Encort-A) 0.1%15g/TubeDrug
Also called Encort-A
only Topical steroids
| Study group | Role | What they receive |
|---|---|---|
| chinese medicine medicated bath | Experimental | we used the leaf of paper mulberry as chinese medicine medicated bath. Two packs per day ,and the period of treatment will be two month. Receives: Drug: paper mulberry leaf; Drug: Triamcinolone (Encort-A) 0.1%15g/Tube |
| control group | Active comparator | Topical steroids Receives: Drug: Triamcinolone (Encort-A) 0.1%15g/Tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
participants achieving either a major clinical response or partial clinical response defind by Psoriasis Area Severity Index(PASI) over the 8 weeks treatment period.
Psoriasis Area Severity Index(PASI) is usually measure the clinical activity diseases of psoriasis.
Measured: baseline to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2019
- Study start5 Oct 2019
- Primary completion31 Dec 2019 (estimated)
- Study completion3 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hui-Man Cheng, Study chair, China Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04117919
- Sponsor's protocol ID
- CMUH107-REC2-182
- Status last verified
- Oct 2019
- First submitted
- 4 Oct 2019
- Last updated
- 16 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Chinese Medicine Medicated Bath as Complementary Medicine for Mild to Moderate Plaque -Type Psoriasis Patient.
- ClinicalTrials.gov ID
- NCT04117919
- Acronym / sponsor ID
- CMUH107-REC2-182
- Conditions
- Psoriasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 5 Oct 2019 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 3 Mar 2020 (estimated)
- First posted
- 7 Oct 2019 (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 a chronic inflammatory skin disease. Plague-type psoriasis is the most common form of the disease, occurring in more than 80% of the cases. This type of psoriasis is characterized by sharply dermatcated, erythematous, scaling plagues that typically affect the elbows, knees, scalp, and trunk. Estimates of the prevalence of psoriasis was vary from 0.5% to 4.6%, with rate varying between countries and races. The prevalence of psoriasis was about 2% in Taiwan. The etiology of psoriasis remains unknown; however, current research mostly indicated that psoriasis was caused by multiple factors, and it was highly related to Th-17 immunal pathway.Treatment of psoriasis included topical therapy, phototherapy and systemic therapy. Although beneficial, those therapies often caused undesirable adverse effects. Traditional Chinese medicine is one of the most fuguently chosen alternative therapies in China and Taiwan, and psoriasis has been treated for centuries with topical and oral herbal prepations. Chinese medicine medicated bath is a characteristic therapy of Traditional Chinese medicine. It combines both hot bath and herbs to enhance absorption of the effective ingredients of herb. There were reports about the application of Chinese medicine medicated bath to treat psoriasis patients in China. We also used Chinese medicine medicated bath (Jing-Fu-Yau-Yu-Bau) as a complementary therapy of psoriasis patients for a long time in China Medical University Hospital. The patient felt well after using Jing-Fu-Yau-Yu-Bau. The component of Jing-Fu-Yau-Yu-Bau is paper mulberry leaf. The botanical origin of paper mulberry leaf is Broussonetia papyrifera (L.) Vent. It can clear heat, cool blood and relieve itching. Based on the 83 journal paper we searched on PubMed, there had been extracted a great deal of phenolics, terpenes and flavonoids from paper mulberry leaf that had antibacterial, antifungal, antioxidant and antineoplastic effects.
This is a single site, randomized, single-blind, controlled pilot study of Jing- Fu-Yau-Yu-Bau as a complementary therapy to treat mild to moderate plaque- type psoriasis during an 8-week period. We estimate to enroll 30 subjects (treatment group(N=15); controlled group(N=15)). We plan to investigate the efficacy and safety of Jing-Fu-Yau-Yu-Bau in Chinese subjects with mild to moderate plaque-type psoriasis.
Detailed description
This is a single site, randomized, single-blind, controlled pilot study of Jing- Fu-Yau-Yu-Bau as a complementary therapy to treat mild to moderate plaque- type psoriasis during an 8-week period. We estimate to enroll 30 subjects (treatment group(N=15); controlled group(N=15)).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| chinese medicine medicated bath | Experimental | Drug: paper mulberry leaf, Drug: Triamcinolone (Encort-A) 0.1%15g/Tubewe used the leaf of paper mulberry as chinese medicine medicated bath. Two packs per day ,and the period of treatment will be two month. |
| control group | Active comparator | Drug: Triamcinolone (Encort-A) 0.1%15g/TubeTopical steroids |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 20-65 years,
- had a diagnosis of plaque-type psoriasis for ≥6 months,
- a Physician's Global Assessment (PGA) score of 2-3, <20% total body surface area (BSA) involvement, and a target plaque of ≥4 cm2.
Key exclusion criteria (15 listed)
- non-plaque psoriasis,
- rebound/flare of chronic psoriasis,
- history of psoriatic arthritis,
- current drug-induced psoriasis,
- pregnant/nursing/planning pregnancy (men and women),
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 |
|---|---|---|
| paper mulberry leafAlso: Triamcinolone (Encort-A) 0.1%15g/Tube, Encort-ATopical steroids+paper mulberry leaf The botanical origin of paper mulberry leaf is Broussonetia papyrifera (L.) Vent. | Drug | chinese medicine medicated bath |
| Triamcinolone (Encort-A) 0.1%15g/TubeAlso: Encort-Aonly Topical steroids | Drug | chinese medicine medicated bath, control group |
Primary outcome
participants achieving either a major clinical response or partial clinical response defind by Psoriasis Area Severity Index(PASI) over the 8 weeks treatment period.
Time frame: baseline to 8 weeks
Psoriasis Area Severity Index(PASI) is usually measure the clinical activity diseases of psoriasis.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2019.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Hui-Man Cheng study chair
China Medical University Hospital
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 paper mulberry leaf and Triamcinolone (Encort-A) 0.1%15g/Tube in people with Psoriasis, run by China Medical University Hospital at 1 site in Taiwan.
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 3 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 16 Oct 2019. 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 Taiwan. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hui-Man Cheng (+886-22052121 ext. 1925, d2227@gmail.cmuh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
participants achieving either a major clinical response or partial clinical response defind by Psoriasis Area Severity Index(PASI) over the 8 weeks treatment period. (time frame: baseline to 8 weeks). 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 16 Oct 2019; AzTrials last refreshed its copy on 7 Nov 2026.