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Psoriasis、Indigo Naturalis、Chinese Medicine Medicated Bath

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ClinicalTrials.gov Identifier: NCT04117919
Recruitment Status : Recruiting
First Posted : October 7, 2019
Last Update Posted : October 16, 2019
Sponsor:
Information provided by (Responsible Party):
China Medical University Hospital

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.


Condition or disease Intervention/treatment Phase
Psoriasis Drug: paper mulberry leaf Drug: Triamcinolone (Encort-A) 0.1%15g/Tube Phase 2

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)).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Pilot Study of Chinese Medicine Medicated Bath as Complementary Medicine for Mild to Moderate Plaque -Type Psoriasis Patient.
Actual Study Start Date : October 5, 2019
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : March 3, 2020


Arm Intervention/treatment
Experimental: chinese medicine medicated bath
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.
Drug: paper mulberry leaf
Topical steroids+paper mulberry leaf The botanical origin of paper mulberry leaf is Broussonetia papyrifera (L.) Vent.
Other Names:
  • Triamcinolone (Encort-A) 0.1%15g/Tube
  • Encort-A

Drug: Triamcinolone (Encort-A) 0.1%15g/Tube
only Topical steroids
Other Name: Encort-A

Active Comparator: control group
Topical steroids
Drug: Triamcinolone (Encort-A) 0.1%15g/Tube
only Topical steroids
Other Name: Encort-A




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04117919


Contacts
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Contact: Hui-Man Cheng +886-22052121 ext 1925 d2227@gmail.cmuh.org.tw

Locations
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Taiwan
No. 91, Xueshi Rd., North Dist., Taichung City 404, Taiwan (R.O.C.) Recruiting
Taichung, Taiwan
Contact: Hui-Man Cheng         
Sponsors and Collaborators
China Medical University Hospital
Investigators
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Study Chair: Hui-Man Cheng China Medical University Hospital
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Responsible Party: China Medical University Hospital
ClinicalTrials.gov Identifier: NCT04117919    
Other Study ID Numbers: CMUH107-REC2-182
First Posted: October 7, 2019    Key Record Dates
Last Update Posted: October 16, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Triamcinolone
Triamcinolone Acetonide
Triamcinolone hexacetonide
Hydrocortisone
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone hemisuccinate
Triamcinolone diacetate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action