Psoriasis、Indigo Naturalis、Chinese Medicine Medicated Bath

NCT04117919 | Unknown Phase 2

• 1 other identifier: CMUH107-REC2-182
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (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.

  Psoriasis Area Severity Index(PASI) is usually measure the clinical activity diseases of psoriasis.

  baseline to 8 weeks

Study Arms (2)

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.

Drug: paper mulberry leaf; Drug: Triamcinolone (Encort-A) 0.1%15g/Tube

control group

ACTIVE COMPARATOR

Topical steroids

Drug: Triamcinolone (Encort-A) 0.1%15g/Tube

Interventions

paper mulberry leaf DRUG

Topical steroids+paper mulberry leaf The botanical origin of paper mulberry leaf is Broussonetia papyrifera (L.) Vent.

Also known as: Triamcinolone (Encort-A) 0.1%15g/Tube, Encort-A

chinese medicine medicated bath

Triamcinolone (Encort-A) 0.1%15g/Tube DRUG

only Topical steroids

Also known as: Encort-A

chinese medicine medicated bath; control group

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• China Medical University Hospital: lead

Study Sites (1)

No. 91, Xueshi Rd., North Dist., Taichung City 404, Taiwan (R.O.C.)

Taichung, Taiwan

RECRUITING

MeSH Terms

Conditions

Psoriasis

Interventions

Triamcinolone

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Hui-Man Cheng

  China Medical University Hospital

  STUDY CHAIR

Central Study Contacts

Hui-Man Cheng

CONTACT

+886-22052121; d2227@gmail.cmuh.org.tw

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2019
• First Posted: October 7, 2019
• Study Start: October 5, 2019
• Primary Completion: December 31, 2019
• Study Completion: March 3, 2020
• Last Updated: October 16, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)