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

Comparison of clinical efficacy and safety of PUVAsol and Unani formulation UNIM-401 (oral) and UNIM-403 (oil) and UVA in the treatment of chronic plaque psoriasis.

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/001253

Enrollment

320

Registered

2010-10-20

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: combination of a systemic (UNIM 401) and a topical (UNIM 403) Unani medication [intervention arm will be given both the oral unani formulation and oil]: UNIM-401: Is an aqueous extract

hours (using established SOPs). Will be applied on lesions followed 2 hours later by gradually increasing doses of sun exposure, starting 2 minutes. Control Intervention1: A combination of standard al

Eligibility

Inclusion criteria

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

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

Design outcomes

Secondary

Measure	Time frame
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	—

Primary

Measure	Time frame
1. Percentage reduction in mean PASI scores in patients with chronic plaque psoriasis on Unani medicine vs the PUVA sol group at 12 weeks. 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. 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 Timepoint: 12 weeks	—

Measure

Time frame

1. Percentage reduction in mean PASI scores in patients with chronic plaque psoriasis on Unani medicine vs the PUVA sol group at 12 weeks. 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. 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 Timepoint: 12 weeks

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Countries

India

Contacts

Public ContactDr Neena Khanna

neena_aiims@yahoo.co.in91-11-26593636

Outcome results