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Study of the Effect of Crocin-containing Drugs in Male Sexual Dysfunctio

Phase 2
Recruiting
Conditions
Men Sexual Dysfunction.
Unspecified sexual dysfunction not due to a substance or known physiological condition
Registration Number
IRCT20130418013058N9
Lead Sponsor
Mashhad University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Male
Target Recruitment
75
Inclusion Criteria

Male married patients (between 18 and 45 years old)
Patients with Major Sexual Dysfunction are Diagnosed with Impotence According to the Diagnostic and Statistical Manual of Mental Disorders, which are treated with Fluoxetine SSRI Antidepressants.
IIEF less than 25
Fluoxetine Consumption at least 6 Weeks Before the Start of the Project
The Ability to Understand the Generalities of the Study, Interventions and Possible Complications
The same Level and Severity of Depression in the Studied Patients

Exclusion Criteria

Other Psychiatric Disorders
The need to Use other Antidepressants During the 4 weeks of Treatment
Substance Abuse During Sample Collection
The Limiting Conditions of Life that Cause the Patient to not Complete the Course of Treatment
Taking other Drugs Like Sildenafil or Cyproheptadine
Sensitivity to Saffron
The Diagnosis of Other Causes of Sexual Dysfunction, such as Vascular Problems, Diabetes, etc. in the patient

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Depression and Anxiety Disorder. Timepoint: Before intervention, One and Two months later. Method of measurement: Beck Depression and Anxiety Questionnaire.
Secondary Outcome Measures
NameTimeMethod
Side Effects of Crocin. Timepoint: Before intervention, one and two months later. Method of measurement: Questionnaire for Side Effect of Crocin.
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