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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05632042
Other study ID # P.T.REC/012/004117
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 16, 2022
Est. completion date April 16, 2023

Study information

Verified date November 2022
Source Cairo University
Contact Ali Ismail, lecturer
Phone 02 01005154209
Email ali.mohamed@pt.cu.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

complaint of sexual dysfunction and metabolic syndrome are highly reported in men with psoriasis


Description:

erectile dysfunction (ED) psoriatic men with metabolic syndrome (number of the patients will be 60) will assigned to study group (group = 30 patients) that will receive lifestyle changes (12 weeks of low calorie diet and moderate-intensity walking on treadmill, the walking duration will be 40 minutes, the walking will be three times per week) or control group (group=30 patients) that will receive no lifestyle changes/modifications.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date April 16, 2023
Est. primary completion date April 16, 2023
Accepts healthy volunteers No
Gender Male
Age group 35 Years to 45 Years
Eligibility Inclusion Criteria: - psoriatic married men with metabolic syndrome and erectile dysfunction Exclusion Criteria: - patients with heart, respiratory, other autoimmune problems

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
lifestyle modification (exercise and control of diet)
erectile dysfunction (ED) psoriatic men with metabolic syndrome that will receive lifestyle changes (12 weeks of low calorie diet and moderate-intensity walking on treadmill, the walking duration will be 40 minutes, the walking will be three times per week)

Locations

Country Name City State
Egypt Cairo Unoversity Giza

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary International Index of Erectile Function Arabic version of this 5-item questionnaire will used to assess erectile function/dysfunction It will be measured after 12-week intervention
Secondary psoriasis area and severity index it is a tool used to measure the severity and extent of psoriasis. It will be measured after 12-week intervention
Secondary body mass index patients will be assessed with empty bowel and bladder It will be measured after 12-week intervention
Secondary systolic blood pressure it will be measured using sphygmomanometer It will be measured after 12-week intervention
Secondary diastolic blood presure it will be measured using sphygmomanometer It will be measured after 12-week intervention
Secondary waist circumference it will be measured by in elastic tape It will be measured after 12-week intervention
Secondary blood glucose it will be measured in fasting status It will be measured after 12-week intervention
Secondary triglycerides it will be measured in serum It will be measured after 12-week intervention
Secondary high density lipoprotein it will be measured in serum It will be measured after 12-week intervention
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