Psoriasis、Indigo Naturalis、Chinese Medicine Medicated Bath
Primary Purpose
Psoriasis
Status
Unknown status
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
paper mulberry leaf
Triamcinolone (Encort-A) 0.1%15g/Tube
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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,
- 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.
Sites / Locations
- No. 91, Xueshi Rd., North Dist., Taichung City 404, Taiwan (R.O.C.)Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
chinese medicine medicated bath
control group
Arm Description
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.
Topical steroids
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04117919
First Posted
October 4, 2019
Last Updated
October 13, 2019
Sponsor
China Medical University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04117919
Brief Title
Psoriasis、Indigo Naturalis、Chinese Medicine Medicated Bath
Official Title
Pilot Study of Chinese Medicine Medicated Bath as Complementary Medicine for Mild to Moderate Plaque -Type Psoriasis Patient.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 5, 2019 (Actual)
Primary Completion Date
December 31, 2019 (Anticipated)
Study Completion Date
March 3, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
China Medical University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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. 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)).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
chinese medicine medicated bath
Arm Type
Experimental
Arm Description
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.
Arm Title
control group
Arm Type
Active Comparator
Arm Description
Topical steroids
Intervention Type
Drug
Intervention Name(s)
paper mulberry leaf
Other Intervention Name(s)
Triamcinolone (Encort-A) 0.1%15g/Tube, Encort-A
Intervention Description
Topical steroids+paper mulberry leaf The botanical origin of paper mulberry leaf is Broussonetia papyrifera (L.) Vent.
Intervention Type
Drug
Intervention Name(s)
Triamcinolone (Encort-A) 0.1%15g/Tube
Other Intervention Name(s)
Encort-A
Intervention Description
only Topical steroids
Primary Outcome Measure Information:
Title
participants achieving either a major clinical response or partial clinical response defind by Psoriasis Area Severity Index(PASI) over the 8 weeks treatment period.
Description
Psoriasis Area Severity Index(PASI) is usually measure the clinical activity diseases of psoriasis.
Time Frame
baseline to 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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,
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hui-Man Cheng
Phone
+886-22052121
Ext
1925
Email
d2227@gmail.cmuh.org.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hui-Man Cheng
Organizational Affiliation
China Medical University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
No. 91, Xueshi Rd., North Dist., Taichung City 404, Taiwan (R.O.C.)
City
Taichung
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hui-Man Cheng
12. IPD Sharing Statement
Plan to Share IPD
No
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