NCT07289399

Brief Summary

Women with psoriasis usually develop many complications including polysyctic ovarian syndrome (PCOS). Nowdays, diet restriction combimed with phsyical exercises may improve both problems

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
0mo left

Started Oct 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress97%
Oct 2025May 2026

Study Start

First participant enrolled

October 10, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 4, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 17, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2026

Last Updated

December 17, 2025

Status Verified

December 1, 2025

Enrollment Period

7 months

First QC Date

December 4, 2025

Last Update Submit

December 4, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Psoariasis area and severity index

    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 Outcomes (16)

  • body mass index

    It will be measured after 12 weeks

  • waist circumference

    It will be measured after 12 weeks

  • waist hip ratio

    It will be measured after 12 weeks

  • testesterone

    it will be measured after 12 weeks

  • ratio of luteinizing hormone and follicle-stimulating hormone

    It will be measured after 12 weeks

  • +11 more secondary outcomes

Study Arms (2)

group number 1

EXPERIMENTAL

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 number 2

ACTIVE COMPARATOR

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

Interventions

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.

group number 1

Group II will will enroll twenty females with PCOS and Psoriasis who will follow low calorie diet and daily metformin for 12 weeks

group number 2

Eligibility Criteria

Age35 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsbased on self-representation of gender identity.
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Giza, Dokki, Egypt

RECRUITING

MeSH Terms

Conditions

PsoriasisPolycystic Ovary Syndrome

Interventions

Exercise

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue DiseasesOvarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Ali MA Ismail, lecturer

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ali MA Ismail, lecturer

CONTACT

Ali mohamed, lecturer

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of physical therapy for Cardiovascular, Respiratory disorder and Geriatrics, Faculty of Physical Therapy, Cairo University

Study Record Dates

First Submitted

December 4, 2025

First Posted

December 17, 2025

Study Start

October 10, 2025

Primary Completion (Estimated)

May 15, 2026

Study Completion (Estimated)

May 15, 2026

Last Updated

December 17, 2025

Record last verified: 2025-12

Locations