CompletedPhase 2/3

Evaluation of the Efficacy and Safety of Indigo Naturalis Oil Extract on Psoriatic Nails

31 participantsStarted 2009-09

Plain-language summary

The purpose of this study is to evaluate efficacy and safety of indigo naturalis oil extract in treating nail psoriasis.

Who can participate

Age range

20 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. adults aged between 20 and 65 years
. received a diagnosis of nail psoriasis with at least one year history based on clinical assessment by two dermatologists and failure of topical systemic Chinese herbal anti-psoriasis therapy for fingernail psoriasis.
. 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%
. a history of allergy to indigo naturalis, or with onychomycosis or any fingernail infection.
. Patients have received systemic therapy within four weeks before enrollment
. Patients have received phototherapy within three weeks, or topical psoriasis agents within two weeks.
. Using medications which affect psoriasis during the study and unwillingness to comply with study protocol.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change From Baseline in Single-Hand Nail Psoriasis Severity Index (NAPSI)and in the Modified Target NAPSI for the Single Most Severely Affected Nail of Each Hand at Week 12.

Timeframe: Baseline and Week 12

Change From Baseline in Single-Hand Nail Psoriasis Severity Index (NAPSI)and in the Modified Target NAPSI for the Single Most Severely Affected Nail of Each Hand at Week 24.

Timeframe: Baseline and Week 24

Trial details

NCT IDNCT00999687

SponsorChang Gung Memorial Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2010-09

Results submitted2012-06-06

View on ClinicalTrials.gov More Nail Psoriasis trials