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Anti-psoriatic Activity of a Novel Polyherbal UNIM 401 Formulatio

Phase 2
Conditions
Health Condition 1: L99- Other disorders of skin and subcutaneous tissue in diseases classified elsewhere
Registration Number
CTRI/2023/07/055205
Lead Sponsor
Central council for Research in Unani Medicine
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

Patients with clinically diagnosed Psoriasis and healthy controls with matched temperament.

Age: 20-50 years.

With any duration of the disease, site, extension and distribution of the lesions.

Willingness to give written informed consent form.

Exclusion Criteria

Subjects with Psoriasis treatment with other drug /systems.

History of drug or alcoholic abuse, chronic smokers not willing to abstain from smoking during the study period.

Any clinically significant abnormality identified on physical examination/laboratory tests.

Subjects having any systemic disease and other skin diseases.

Subjects with known allergies. Impaired cardiac, hepatic and renal function. History of malignancy. Concomitant use of any other antioxidants.

Pregnant and other lactating women. Pregnant and other lactating women.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
The present study will provide an understanding about the cellular level via multiple arms (ant proliferative, pro-apoptotic, anti-inflammatory, anti-antigenic) of UNIM formulation (UNIM401). <br/ ><br> <br/ ><br>It also provides insight into mechanism of action of formulation & highlights its promising potential for development as an herbal therapeutic agent for psoriasis, emphasizing the need of further pharmacological evaluation & toxicological studies <br/ ><br>Timepoint: 3 years
Secondary Outcome Measures
NameTimeMethod
The present study will provide an understanding about the cellular & molecular mechanism of Unani formulation (UNIM 401) being used for treatment of various diseases from centuries keeping in mind the Unani Philosophy. <br/ ><br> <br/ ><br>Further the study will help in validation of their safety and anti-inflammatory properties. Exploration of cellular and molecular mechanism involved in anti-inflammatory properties and the scientific validation in terms of mechanistic study for Unani drug will help to create an evidence based data and will pave the way for acceptability of these drugs globally <br/ ><br>Timepoint: 3 years
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