PsoriasisNCT07289399
Is There a Benefit From Addition of Treadmill Walking to Diet Restriction in Psoriasis Women With PCOS?
A study testing exercise and diet restriction and diet restriction in people with Psoriasis and Polycystic Ovary Syndrome, run by Cairo University at 1 site in Egypt.
Trial summary
Women with psoriasis usually develop many complications including polysyctic ovarian syndrome (PCOS). Nowdays, diet restriction combimed with phsyical exercises may improve both problems Read more about this study
- Who is it for?
- Ages 35 to 45 years, women only
- Conditions the study is for
- Psoriasis, Polycystic Ovary Syndrome
- What is being tested?
- exercise and diet restriction and diet restriction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Oct 2025to 15 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- obese (class I) women
- chronic plaque psoriasis
- polyscytic ovarian syndrome
Who cannot join
- cardiac dysfucntions
- liver diseases
- repsiratory disease
- vascular diseases
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University
Giza, Dokki
ali ismail, lecturer, 02 01005154209, ali.mohamed@pt.cu.edu.eg
About this study
Women with psoriasis usually develop many complications including polysyctic ovarian syndrome (PCOS). Nowdays, diet restriction combimed with phsyical exercises may improve both problems
Read the 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
- Conditions
- Psoriasis, Polycystic Ovary Syndrome
- Being tested
- exercise and diet restriction, diet restriction
- Medical subject headings
- Psoriasis, Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercise and diet restrictionBehavioural
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.
diet restrictionBehavioural
Group II will will enroll twenty females with PCOS and Psoriasis who will follow low calorie diet and daily metformin for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Behavioral: diet restriction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: it will be measured after 12 weeks
Secondary outcomes (16)
body mass index
it will be assessed after emptying bladder and bowel
Measured: It will be measured after 12 weeks
waist circumference
it will be measured at level of ambilicus
Measured: It will be measured after 12 weeks
waist hip ratio
it will be assessed after dividing waist circumference on hip circumference
Measured: It will be measured after 12 weeks
testesterone
it will be assessed in serum
Measured: it will be measured after 12 weeks
ratio of luteinizing hormone and follicle-stimulating hormone
it is anindicator on function of sex hormones
Measured: It will be measured after 12 weeks
Dehydroepiandrosterone
it will be assessed in plasma
Measured: It will be measured after 12 weeks
Dermatology life Quality Index
it assess impact of skin disease on quality of life
Measured: It will be measured after 12 weeks
insuiln
it will be assessed in plasma
Measured: It will be measured after 12 weeks
fasting blood glucose
it will be assessed in plasma
Measured: It will be measured after 12 weeks
HOMA-IR
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) is classically considered to be a good insulin resistance (IR) index
Measured: It will be measured after 12 weeks
triglycerides
it will be assessed in plasma
Measured: It will be measured after 12 weeks
total cholesterol
it will be assessed in plasma
Measured: It will be measured after 12 weeks
high density lipoprotein
it will be assessed in plasma
Measured: It will be measured after 12 weeks
low density lipoprotein
it will be assessed in plasma
Measured: It will be measured after 12 weeks
systolic blood pressure
it will be assessed via manual sphygmmanometer
Measured: It will be measured after 12 weeks
diatolic blood pressure
it will be assessed via manual sphygmmanometer
Measured: It will be measured after 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2025
- Study start10 Oct 2025
- Primary completion15 May 2026 (estimated)
- Study completion15 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Mohamed Ali ismail, Cairo University
- Investigators
- Ali MA Ismail, lecturer, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07289399
- Sponsor's protocol ID
- IRB00014233-58
- Status last verified
- Dec 2025
- First submitted
- 4 Dec 2025
- Last updated
- 17 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is There a Benefit From Addition of Treadmill Walking to Diet Restriction in Psoriasis Women With PCOS?
- ClinicalTrials.gov ID
- NCT07289399
- Acronym / sponsor ID
- IRB00014233-58
- Conditions
- Psoriasis, Polycystic Ovary Syndrome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Oct 2025 (actual)
- Primary completion
- 15 May 2026 (estimated)
- Study completion
- 15 May 2026 (estimated)
- First posted
- 17 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Women with psoriasis usually develop many complications including polysyctic ovarian syndrome (PCOS). Nowdays, diet restriction combimed with phsyical exercises may improve both problems
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group number 1 | Experimental | Behavioral: exercise and diet restrictionGroup 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 number 2 | Active comparator | Behavioral: diet restrictionGroup II will will enroll twenty females with PCOS and Psoriasis who will follow low calorie diet and daily metformin for 12 weeks |
Who may qualify
- Ages
- 35 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- obese (class I) women
- chronic plaque psoriasis
- polyscytic ovarian syndrome
Key exclusion criteria (4 listed)
- cardiac dysfucntions
- liver diseases
- repsiratory disease
- vascular diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exercise and diet restrictionGroup 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. | Behavioural | group number 1 |
| diet restrictionGroup II will will enroll twenty females with PCOS and Psoriasis who will follow low calorie diet and daily metformin for 12 weeks | Behavioural | group number 2 |
Primary outcome
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
16 secondary outcomes
body mass index
Time frame: It will be measured after 12 weeks
waist circumference
Time frame: It will be measured after 12 weeks
waist hip ratio
Time frame: It will be measured after 12 weeks
testesterone
Time frame: it will be measured after 12 weeks
ratio of luteinizing hormone and follicle-stimulating hormone
Time frame: It will be measured after 12 weeks
Dehydroepiandrosterone
Time frame: It will be measured after 12 weeks
Dermatology life Quality Index
Time frame: It will be measured after 12 weeks
insuiln
Time frame: It will be measured after 12 weeks
fasting blood glucose
Time frame: It will be measured after 12 weeks
HOMA-IR
Time frame: It will be measured after 12 weeks
triglycerides
Time frame: It will be measured after 12 weeks
total cholesterol
Time frame: It will be measured after 12 weeks
high density lipoprotein
Time frame: It will be measured after 12 weeks
low density lipoprotein
Time frame: It will be measured after 12 weeks
systolic blood pressure
Time frame: It will be measured after 12 weeks
diatolic blood pressure
Time frame: It will be measured after 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ali MA Ismail, lecturer principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise and diet restriction and diet restriction in people with Psoriasis and Polycystic Ovary Syndrome, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ali MA Ismail, lecturer (01005154209, ali.mohamed@pt.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psoariasis area and severity index (time frame: it will be measured after 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025.