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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tadalafil | Experimental | Tadalafil 10 mg once daily per oral for 3 months |
|
| Placebo | Placebo Comparator | Tablet placebo once daily per oral for 3 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tadalafil 10 MG | Drug | Tadalafil 10 mg per oral once daily for 3 months |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Proportions of patients achieving more than a five-point gain from baseline to end point in the erectile function domain of the IIEF ( International Index of Erectile Function). | 3 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with erectile Dysfunction | 1.5 years | |
| Side effects of tadalafil drug | 3 months | |
| Reduction in HVPG (Hepatic Venous Pressure Gradient) ≥10 in both groups |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr Rakesh Kumar Jagdish | New Delhi | National Capital Territory of Delhi | 110070 | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34775577 | Derived | Jagdish RK, Kamaal A, Shasthry SM, Benjamin J, Maiwall R, Jindal A, Choudhary A, Rajan V, Arora V, Bhardwaj A, Kumar G, Kumar M, Sarin SK. Tadalafil improves erectile dysfunction and quality of life in men with cirrhosis: a randomized double blind placebo controlled trial. Hepatol Int. 2023 Apr;17(2):434-451. doi: 10.1007/s12072-021-10264-w. Epub 2021 Nov 14. |
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| ID | Term |
|---|---|
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000068581 | Tadalafil |
| ID | Term |
|---|---|
| D002243 | Carbolines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Placebo |
| Other |
TPlacebo tablet per oral once daily for 3 months |
|
| 3 Months |
| Change in Sexual Encounter Profile (SEP) in both groups | 3 Months |
| Global Assessment Index in both groups | 3 Months |
| Improvement in q ADAMS in both groups | 3 Months |
| Improvement in PHQ 9 in both groups | 3 Months |
| Improvement in GAD 7 in both groups | 3 Months |
| Improvement in SF-36 in both groups | 3 Months |
| D026121 |
| Indole Alkaloids |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006575 | Heterocyclic Compounds, 3-Ring |