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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01022502 |
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Date of registration:
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25/11/2009 |
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Primary sponsor: |
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Public title:
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Comparison of Refined and Crude Indigo Naturalis Ointment in Treating Psoriasis
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Scientific title:
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Efficacy and Safety Comparison Between Refined and Crude Indigo Naturalis Ointment in the Treatment of Psoriatic Vulgaris |
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Date of first enrolment:
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November 2009 |
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Target sample size:
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38 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01022502 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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Countries of recruitment
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Taiwan
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Contacts
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Name:
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Yin-Ku Lin, MD. PhD. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Chang Gung Memorial Hospital |
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Key inclusion & exclusion 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.
Age minimum:
20 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Psoriasis Vulgaris
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Intervention(s)
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Drug: crude indigo naturalis ointment
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Drug: refined indigo naturalis ointment
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Primary Outcome(s)
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Change From Baseline in Psoriasis Severity Idex(PSI) at Week 8.
[Time Frame: Baseline and Week 8]
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Clearing Percentage of Target Plaque Area
[Time Frame: Baseline and Week 8]
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Percentage Improvement Compared to Baseline in the Target Plaque.
[Time Frame: Baseline and Week 8]
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Secondary Outcome(s)
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Patients Preferred Ointment Type.
[Time Frame: Week 8]
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Patients' Rating of the Overall Improvement at Week 8
[Time Frame: Baseline and Week 8]
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Secondary ID(s)
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CMRPG280391
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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