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.

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20230618058508N1

Enrollment

Registered

2023-07-02

Start date

2023-07-23

Completion date

Unknown

Last updated

2023-07-25

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

Conditions

Psoriasis. Psoriasis vulgaris

Interventions

Intervention 1: Intervention group: They will receive the existing standard treatment of emollient ointment (20% glycerine based on Oserin) and tar shampoo + oral whey protein with terminalia chebul

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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).	—

Measure

Time frame

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).

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactNasrin Azhang

Tehran University of Medical Sciences

nasrinazhang@yahoo.com+98 21 8897 4535

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026