Evaluation of the role of oral whey protein with Terminalia Chebula(an Iranian Medicine product) on mild to moderate skin lesion of psoriasis – A Triple-blind randomized controlled trial.

Phase 3

Recruiting

• Conditions: Psoriasis.; L40.0; Psoriasis vulgaris

• Registration Number: IRCT20230618058508N1
• Lead Sponsor: Tehran University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 25 July 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Age between 18 and 60
Less than 10% of skin involvement
Suffering from controlled plaque psoriasis (Unchanged damages in terms of severity and extent in the last 2 months)
Not using psoralen in the last 28 days and not receiving UVB in the last 30 days
No kidney disease or kidney stones
Not being during pregnancy and breastfeeding
Not participating in any study in the last month
Consent to participate in the study

Exclusion Criteria

Suffering from other types of psoriasis, such as pustular, erythrodermic, palmoplantar, psoriatic arthritis
Allergy to milk and other dairy product
Suffering from kidney stones and kidney disease
Using drugs aggravating psoriasis, such as beta-blockers, non-steroidal anti-inflammatory drugs, calcium channel blockers, interleukins, and lithium
suffering from uncontrolled cardiovascular, respiratory, hematologic or urinary diseases

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assessment of disease severity. Timepoint: Before starting the treatment and at the end of weeks 6 and 12. Method of measurement: Using PASI score.;Evaluation of the extent of the lesion. Timepoint: Before starting the treatment and at the end of weeks 6 and 12. Method of measurement: Using the BSA index.;Assessment of quality of life. Timepoint: It is evaluated before the start of the treatment and at the end of the 12th week. Method of measurement: Using the DLQI index, which is taken from the patient in the form of a questionnaire.;Assessment of itching severity. Timepoint: It is evaluated before the start of the treatment and at the end of weeks 6 and 12. Method of measurement: Using the VAS index.;Investigation of possible gastrointestinal and skin complications. Timepoint: At the end of weeks 6 and 12. Method of measurement: Using the fifth version of Common Terminology for Adverse Event questionnaire (CTCAE).