Clinical efficacy and safety of a standard allopathic treatment and a Unani regime in the treatment of a skin disorder called psoriasis.

Phase 3

Registration Number: CTRI/2010/091/001253

Lead Sponsor: Dr. Neena KhannaDeptt. Dermatology and VenereologyAll India Institute of Medical SciencesNew Delhi 110029

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 320

Inclusion Criteria

Patients with chronic plaque psoriasis who meet all of the following criteria will be included:

Age > 18 years

Psoriasis area severity index (PASI) of >10%

Body surface involvement (BSA) of >10%

Exclusion Criteria

1.Patients with chronic plaque psoriasis < BSA 10% or PASI <10.
2.Patients< 18 years of age
3.Pregnant and lactating mothers
4.Patients with previous serious adverse effects to photochemotherapy, abnormal photosensitivity or photoaggravated psoriasis.
5.Patients with renal, hepatic or severe cardiac disease.
6.Patient with personal or family history of pre-malignant or malignant skin tumors.
7.Patient unsure about attending treatment schedule regularly and those who do not have a suitable place for sun exposure.
8.Patients who have received systemic therapy for psoriasis or those who have been treated with immunosuppressive/immunomodulating treatment in previous 8 weeks.
9.Patients not willing to give consent

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br><br>1.Percentage reduction in mean PASI scores in patients with chronic plaque psoriasis on Unani medicine vs the PUVA sol group at 12 weeks.<br>2.Percentage of patients achieving PASI 50, PASI 75 and PASI 90 in patients on Unani medicine vs the PUVA sol group at 12 weeks.<br>3.Percentage of patients developing adverse events (AEs) in patients on Unani medicine vs the PUVA sol group and percentage of patients in whom treatment was withdrawn due to AEs <br><br>Timepoint: 12 weeks

Secondary Outcome Measures

Name	Time	Method
Percentage of patients who relapse in the follow up period of 12 weeks in patients with chronic plaque psoriasis on Unani medicine vs PUVA sol.Timepoint: follow up period of 12 weeks