Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Patients of cirrhosis aged 18 to 75 years who have no esophageal varices will be enrolled. After baseline evaluation, the participants will be randomized to receive either Placebo or Carvedilol 12.5 mg BD. After randomization they will be followed up for one year.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Carvedilol | Experimental | Tablet 6.25 mg BD |
|
| placebo | Placebo Comparator | Placebo tablets 2 BD |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| carvedilol | Drug | Carvedilol will be administered orally at a start dose of 3.125 mg twice daily. After 1 week, this will increased if systolic blood pressure does not fall below 90 mm Hg. The patient will receive the maximum tolerated dose of carvedilol with a maximum of 6.25 BD. |
| Measure | Description | Time Frame |
|---|---|---|
| the proportions of patients who develop esophageal varices at 1 year in each group. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patient dying in a period of one year | 1 year | |
| Number of patients needing discontinuation of therapy due to adverse effects. | 1 year | |
| Reduction in Hepatic Venous Pressure Gradient in both groups |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dr Ankur Jindal, DM | Contact | 011-46300000 | ankur.jindal3@gmail.com | |
| Dr Ankit Bhardwaj, PhD (Epidemiology) | Contact | 01146300000 | bhardwaj.ankit3@gmail.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Liver & Biliary Sciences (ILBS) | Recruiting | New Delhi | National Capital Territory of Delhi | India |
Not provided
| ID | Term |
|---|---|
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077261 | Carvedilol |
| ID | Term |
|---|---|
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Placebo | Drug | The placebo tablets will be identical to the carvedilol tablets. First the patients will receive placebo in the dose of 1 BD. Then depending on his tolerance it will be increased to a maximum of 2 BD. |
|
| 1 year |
| D020005 |
| Propanols |
| D000588 | Amines |
| D002227 | Carbazoles |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D006575 | Heterocyclic Compounds, 3-Ring |