Is There a Benefit From Addition of Treadmill Walking to Diet Restriction in Psoriasis Women With PCOS?

December 4, 2025 updated by: Ali Mohamed Ali ismail, Cairo University
Women with psoriasis usually develop many complications including polysyctic ovarian syndrome (PCOS). Nowdays, diet restriction combimed with phsyical exercises may improve both problems

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Forty Women with psoriasis with PCOS will be enrolled to be catogrized to Group I or group II. Group I will enroll twenty females with PCOS and Psoriasis who will apply forty minutes walking on treadmill three times per week. Also Group I will follow low calorie diet and daily metformin for 12 weeks. Group II will will enroll twenty females with PCOS and Psoriasis who will follow low calorie diet and daily metformin for 12 weeks

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Egypt
    • Dokki
      • Giza, Dokki, Egypt
        • Recruiting
        • Cairo University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • obese (class I) women
  • chronic plaque psoriasis
  • polyscytic ovarian syndrome

Exclusion Criteria:

  • cardiac dysfucntions
  • liver diseases
  • repsiratory disease
  • vascular diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: group number 1
Group I will enroll twenty females with PCOS and Psoriasis who will apply forty minutes walking on treadmill three times per week. Also Group I will follow low calorie diet and daily metformin for 12 weeks.
Behavioral: exercise and diet restriction
Group I will enroll twenty females with PCOS and Psoriasis who will apply forty minutes walking on treadmill three times per week for 12 weeks. Also Group I will follow low calorie diet and daily metformin for 12 weeks.
Active Comparator: group number 2
Group II will will enroll twenty females with PCOS and Psoriasis who will follow low calorie diet and daily metformin for 12 weeks
Behavioral: diet restriction
Group II will will enroll twenty females with PCOS and Psoriasis who will follow low calorie diet and daily metformin for 12 weeks

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Psoariasis area and severity index
Time Frame: it will be measured after 12 weeks
is an index used to express the severity of psoriasis. It combines the severity (erythema, induration and desquamation) and percentage of affected area
it will be measured after 12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
triglycerides
Time Frame: It will be measured after 12 weeks
it will be assessed in plasma
It will be measured after 12 weeks
body mass index
Time Frame: It will be measured after 12 weeks
it will be assessed after emptying bladder and bowel
It will be measured after 12 weeks
waist circumference
Time Frame: It will be measured after 12 weeks
it will be measured at level of ambilicus
It will be measured after 12 weeks
waist hip ratio
Time Frame: It will be measured after 12 weeks
it will be assessed after dividing waist circumference on hip circumference
It will be measured after 12 weeks
testesterone
Time Frame: it will be measured after 12 weeks
it will be assessed in serum
it will be measured after 12 weeks
ratio of luteinizing hormone and follicle-stimulating hormone
Time Frame: It will be measured after 12 weeks
it is anindicator on function of sex hormones
It will be measured after 12 weeks
Dehydroepiandrosterone
Time Frame: It will be measured after 12 weeks
it will be assessed in plasma
It will be measured after 12 weeks
Dermatology life Quality Index
Time Frame: It will be measured after 12 weeks
it assess impact of skin disease on quality of life
It will be measured after 12 weeks
insuiln
Time Frame: It will be measured after 12 weeks
it will be assessed in plasma
It will be measured after 12 weeks
fasting blood glucose
Time Frame: It will be measured after 12 weeks
it will be assessed in plasma
It will be measured after 12 weeks
HOMA-IR
Time Frame: It will be measured after 12 weeks
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) is classically considered to be a good insulin resistance (IR) index
It will be measured after 12 weeks
total cholesterol
Time Frame: It will be measured after 12 weeks
it will be assessed in plasma
It will be measured after 12 weeks
high density lipoprotein
Time Frame: It will be measured after 12 weeks
it will be assessed in plasma
It will be measured after 12 weeks
low density lipoprotein
Time Frame: It will be measured after 12 weeks
it will be assessed in plasma
It will be measured after 12 weeks
systolic blood pressure
Time Frame: It will be measured after 12 weeks
it will be assessed via manual sphygmmanometer
It will be measured after 12 weeks
diatolic blood pressure
Time Frame: It will be measured after 12 weeks
it will be assessed via manual sphygmmanometer
It will be measured after 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cairo University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ali MA Ismail, lecturer, Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 10, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 15, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 15, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 4, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 4, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 17, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 17, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 4, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB00014233-58

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Polycystic Ovary Syndrome

Clinical Trials on exercise and diet restriction

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings