Clinical trial

Evaluation of the Effect of Acetylcysteine and Vitamin E on Psoriasis Vulgaris Patients During The Active Phase

Name

Acetylcysteine in Psoriasis

Description

This study aims to assess the effect of adding N-acetyl cysteine (NAC) alone or in combination with Vitamin E to conventional therapy in improving the clinical outcome, oxidative stress, and inflammation in patients with mild psoriasis vulgaris

Trial arms

Trial start

2022-12-01

Estimated PCD

2023-11-01

Trial end

2023-12-01

Status

Recruiting

Phase

Early phase I

Treatment

Acetyl cysteine

N-acetyl cysteine (NAC) is synthetic cysteine amino acid, which in turn elevate the glutathione level in the body, which have important direct antioxidant activity.

Arms:

acetylcysteine, mix acetylcysteine with vitamin E

Vitamin E

vitamin E possessing an anti-inflammatory action

Arms:

mix acetylcysteine with vitamin E

Size

Primary endpoint

level of interleukin-36(IL-36 gamma) (Pg/ml)

4 months

level of Malondialdehyde (MDA) (µmol/L)

4 months

Eligibility criteria

Inclusion Criteria: 1. Adult Patients from 18 to 65 years. 2. Gender: both males and females. 3. Mild psoriatic patients in the active phase (score \< =3) 4. Patients diagnosed with mild psoriasis in the active phase (score less than or equal 3) using PASI score. Exclusion Criteria: 1. Inactive psoriasis vulgaris patients. 2. Alcohol consumption 3. Any other autoimmune diseases. 4. Pregnant or lactating women. 5. Patients with serious illness and any systemic failure (cardiovascular, renal, or respiratory) 6. Patients with major psychiatric or mental illness. 7. Intake of any antioxidants in the previous 3 months 8. Patients of chronic diseases, like hypertension, heart problems 9. Patients with history of bleeding, ulcers, or uncontrollable heartburn. 10. Patients taking anticancer medications that can aggravate psoriasis vulgaris such as mercaptopurine, vinblastine, actinomycin, and Radiation

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 60, 'type': 'ESTIMATED'}}

Updated at

2023-06-18

1 organization

2 products

1 indication

Organization

Product

Indication

Product