A Herbal Compound for Psoriasis

NCT ID: NCT06301997

Last Updated: 2025-03-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-01

Study Completion Date

2025-07-30

Brief Summary

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The goal of this interventional clinical trial study is to compare ZAX.1400.P03 and placebo in Psoriasis patients. The main question it aims to answer is:

• Can treatment with ZAX.1400.P03 for 3 weeks improve clinical signs of skin in psoriasis patients? Participants will be divided into two groups of 52 people. One group will use ZAX.1400.P03 topically twice daily for 3 weeks and the other group will use placebo topically twice daily for 3 weeks.

Researchers will compare treatment and placebo groups to see if there is any improvement in the clinical signs of skin caused by psoriasis after treatment with ZAX.1400.P03 for 3 weeks.

Detailed Description

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Conditions

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Psoriasis Inflammation Skin Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Topical ZAX.1400.P03

ZAX.1400.P03, applied topically twice daily for 3 weeks after enrolment

Group Type EXPERIMENTAL

ZAX.1400.P03

Intervention Type DIETARY_SUPPLEMENT

ZAX.1400.P03, applied twice daily for 3 weeks after enrolment

Placebo

Placebo, applied topically twice daily for 3 weeks after enrolment

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo, applied twice daily for 3 weeks after enrolment

Interventions

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ZAX.1400.P03

ZAX.1400.P03, applied twice daily for 3 weeks after enrolment

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo, applied twice daily for 3 weeks after enrolment

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of the disease by a doctor
* Age range between 18 and 60 years
* Both sexes (male and female)
* Having written informed consent to participate in the study
* Lack of allergy to food and health products
* Only local tissue involvement and no need to take oral medications
* Absence of underlying diseases and immune deficiency
* Absence of pregnancy and breastfeeding
* Absence of blisters and infection caused by the disease

Exclusion Criteria

* Non-consent of the doctor directly responsible for the patient
* Incidence of drug product allergy
* Occurrence of symptoms of skin, digestive, liver or kidney diseases
* Patient\'s lack of consent to continue for any reason
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zarrin Avaye Kowsar Salamat (ZAX company) and HerbmedX

UNKNOWN

Sponsor Role collaborator

Herbmedx Co

INDUSTRY

Sponsor Role collaborator

Fasa University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Akbar Farjadfar

Principle-Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Fasa university of medical sciences

Fasa, Fars, Iran

Site Status

Countries

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Iran

Other Identifiers

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IR.FUMS.REC.1400.125

Identifier Type: OTHER

Identifier Source: secondary_id

IRCT20210218050404N5

Identifier Type: -

Identifier Source: org_study_id

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