Tadalafil for Erectile Dysfunction in Patients With Cirrhosis
Status:
Completed
Trial end date:
2019-12-28
Target enrollment:
Participant gender:
Summary
This study will be conducted into two parts 1) Screening of 400 cases of cirrhosis (Child
A,child B and child c) for the prevalence and risk factors of erectile dysfunction in
cirrhosis.2) The part 2 is RCT as follows where 70 cases in each arm will be taken wuth child
A and child B cirrhosis for the effect of treatment on erectile dysfunction (Tadalafil vs
Placebo).
After getting informed consent. Clinical, anthropometric and biochemical assessment will be
done by candidate, co-supervisors and supervisor. Screening and selection criteria by using
various questionnaire like Karnofsky Performance Score (KPS) , IIEF Questionnaire , ADAMS
Questionnaire, Generalized Anxiety Disorder 7 (GAD-7) questionnaire, Patient Health
Questionnaire (PHQ-9 for depression ; and SF-36 questionnaire).
The informed consent will be obtained from the participants in the study. Patients-ED IIEF<25
will be included as per inclusion and exclusion criteria. Tadalfil regimen: 10 mg daily at
any time before anticipated sexual activity on days with anticipated sexual activity On days
with no anticipated sexual activity: 10 mg daily at night after meals. Follow-up1 week,
2weeks, 4weeks, 12 weeks with history, clinical examination and laboratory test.