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Comparison of Refined and Crude Indigo Naturalis Ointment in Treating Psoriasis

NCT ID: NCT01022502

Last Updated: 2012-10-16

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2010-12-31

Brief Summary

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To compare the efficacy and safety of refined indigo naturalis ointment with that of crude ointment in treating psoriasis.

Detailed Description

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Our previous studies have shown that topical application of indigo naturalis significantly improves psoriatic symptoms. However, patient compliance is hindered because the preparation is unsightly and stains clothing.

To improve patient compliance, we have developed a refined formulation in which closer to natural skin tones and less prone to stain clothing. In this study, we evaluated the efficacy and safety of this refined form of oil extract ointment and compared the results with those of the original crude form of indigo naturalis ointment in treating psoriasis.

Conditions

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Psoriasis Vulgaris

Keywords

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psoriasis, indigo naturalis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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refined indigo naturalis ointment

Refined indigo naturalis ointment was applied topically to one of 2 bilaterally symmetrical psoriatic plaque lesions of the same patient for 8 weeks, starting on the date of enrollment in the study

Group Type ACTIVE_COMPARATOR

refined indigo naturalis ointment

Intervention Type DRUG

The patients applied either refined oil extract or crude indigo naturalis ointmnet topically to each of two bilaterally symmetrical psoriatic plaque lesions for 8 weeks.

crude indigo naturalis ointment

Crude indigo naturalis ointment was applied topically to one of 2 bilaterally symmetrical psoriatic plaque lesions of the same patient for 8 weeks, starting on the date of enrollment in the study

Group Type ACTIVE_COMPARATOR

crude indigo naturalis ointment

Intervention Type DRUG

The patients applied either refined oil extract or crude indigo naturalis ointmnet topically to each of two bilaterally symmetrical psoriatic plaque lesions for 8 weeks.

Interventions

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refined indigo naturalis ointment

The patients applied either refined oil extract or crude indigo naturalis ointmnet topically to each of two bilaterally symmetrical psoriatic plaque lesions for 8 weeks.

Intervention Type DRUG

crude indigo naturalis ointment

The patients applied either refined oil extract or crude indigo naturalis ointmnet topically to each of two bilaterally symmetrical psoriatic plaque lesions for 8 weeks.

Intervention Type DRUG

Other Intervention Names

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refined ointment Crude ointment

Eligibility Criteria

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Inclusion Criteria

* Patients were had received a diagnosis of plaque psoriasis based on clinical assessment by two dermatologists at least a one year prior to entry into the study;
* Patients had mild to moderate plaque psoriasis with bilateral symmetric lesions; were adults aged 20 to 65 years;
* Patients were in good general health.
* Female patients of childbearing age agreed to continue using birth control measures for the duration of the study.

Exclusion Criteria

* Patients had non-plaque (i.e., pustular, guttate, or erythrodermic) or drug-induced forms of psoriasis; total body surface involvement of more than 60%;
* Patients had a history of allergy to indigo naturalis.
* Patients were excluded if they have received systemic therapy within 4 weeks before enrollment, phototherapy within 3 weeks, or used topical psoriasis agents within 2 weeks before enrollment.
* Patients had included usage of medications that affect psoriasis during the study and unwillingness to comply with study protocol.
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Yin-ku Lin

OTHER

Sponsor Role lead

Responsible Party

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Yin-ku Lin

Chief of Department of Traditional Chinese Medicine

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Yin-Ku Lin, MD. PhD.

Role: PRINCIPAL_INVESTIGATOR

Chang Gung Memorial Hospital

Locations

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Chang Gung Memorial Hospital

Keelung, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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CMRPG280391

Identifier Type: -

Identifier Source: org_study_id