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A Study of Topical Indigo Naturalis Treatment in Patients With Mild to Moderate Plaque-type Psoriasis

NCT01901705 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2017-02-06

No results posted yet for this study

Summary

Psoriasis is a common, chronic skin disease for which only remissive, as opposed to curative, treatments are available. Traditional Chinese medicine is one of the most frequently chosen alternative therapies in China and Taiwan, and psoriasis has been treated for centuries with topical and oral herbal preparations. Topical indigo naturalis ointment has been reported to exhibit potential anti-psoriatic efficacy. The study objective is to investigate pharmacological effect and explore targeting mechanisms of Traditional Chinese Medicine (TCM) Indigo Naturalis topical ointment as a single treatment agent in Chinese subjects with mild to moderate plaque-type Psoriasis.

This was a single site, randomized, double-blinded, placebo controlled study of topical indigo naturalis vs. vehicle alone (placebo) to treat mild to moderate plaque-type psoriasis during an 8-week period. Pharmacological effect will be evaluated by biomarker evaluation and clinical evaluation. The trial was conducted at the China Medical University Hospital (CMUH), Taichung, Taiwan. All patients provided written informed consent before inclusion in the study. The study protocol was approved by the institutional review board (IRB) of CMUH.

Conditions

Interventions

DRUG

Indigo naturalis ointment

The Indigo naturalis ointment was composed of a 1:10 mixture of Indigo naturalis powder and a vehicle consisting of Vaseline: microcrystalline wax: olive oil (5:6:9 ratio)

DRUG

Placebo

The placebo was a mixture of blue dye powder (54.8% Indigo carmine aluminum lake \[Blue #32\] and 45.2% Allura Red AC aluminum lake \[Red #40\] powders), Vaseline, microcrystalline wax, and olive oil.

Sponsors & Collaborators

  • China Medical University Hospital

    lead OTHER

Principal Investigators

  • Hui man cheng · China Medical University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2014-01-31
Completion
2014-01-31

Countries

  • Taiwan

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01901705 on ClinicalTrials.gov