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Clinical Study to Investigate Psorax35 Supplementation in Patients With Psoriasis

Brief Summary:
The main objective of this study is to establish the efficacy and safety of Psorax35 supplementation in patients with mild to moderate Psoriasis.

Condition or disease Intervention/treatment
Psoriasis Vulgaris Dietary Supplement: Psorax35 Dietary Supplement: MCT oil

Detailed Description:

Psoriasis is a common, genetically predisposed, inflammatory and proliferative disease of the skin, the most characteristic lesions consisting of chronic, sharply demarcated, dull-red scaly plaques, particularly on extensor parts of limbs and in the scalp. Psoriasis can be divided into mild, moderate or severe psoriasis based on the extent of the skin changes

Psorax35, which is extracted from herring roe are shown to improve the condition of people with psoriasis.

The objective of this study is to investigate the effect, safety, and mechanism of action of Psorax35 on mild to moderate Psoriasis and comorbidities associated with psoriasis through a 32-weeks study.

The participants will be randomized into one of two arms; Psorax35 and Placebo. The study will include a total of 6 treatment visits involving Blood samples, Photo documentation, Psoriasis and Severity index (PASI), Body surface area (BSA), Physician’s Static Global Assessment (PSGA), Life quality index (EQ-5D, VAS and DLQI), Blood pressure, Blood rate, Body Mass Index (BMI), Waist circumference, Waist/hip ratio, and 24 hrs dietary recall. At visit 4 Blood samples, Blood pressure, Blood rate, BMI, Waist circumference, Waist/hip ratio, and 24 hrs dietary recall are not included.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment :60 participants
Allocation:Randomized
Intervention Model:Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title:Randomized, Double Blind, Placebo Controlled Clinical Study to Investigate Efficacy of Psorax35 for Treatment of Psoriasis
Actual Study Start Date :November 21, 2017
Estimated Primary Completion Date :August 31, 2018
Estimated Study Completion Date :August 31, 2018
Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

U.S. FDA Resources

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