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Study Population- Patient with cirrhosis with any aetiology with sarcopenia visiting ILBS OPD/IPDs who are willing to visit ILBS gymnasium twice weekly for first month.
Study Design- A Prospective Randomized Controlled Trial
Study Period- Study will be conducted at ILBS from April 2019 to Oct 2019
Intervention - Testosterone Supplementation - Intramuscular Testosterone Undecanoate 1000 Mg (4 ml volume in oily base) will be injected into the upper, outer quadrant of the buttock at 0, 6, 12,16,20, 24 weeks according to manufacturer recommendations.
Monitoring and assessment - On every visit patient will be inquired or evaluated for side effects like local site pain or hematoma , hypertension, headache, allergic reactions, acne, nausea , mood swings, pedal edema , breast enlargement and others.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Medical Treatment +Intramuscular Testosterone + Exerc | Experimental | Intramuscular Testosterone Undecanoate 1000 Mg (4 ml volume in oily base) will be injected into the upper, outer quadrant of the buttock at 0, 6, 12,16,20, 24 weeks according to manufacturer recommendations |
|
| Standard Medical Treatment+Exercise | Active Comparator | Standard Medical Treatment +Exercise |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Testosterone Supplementation | Drug | Intramuscular Testosterone Undecanoate 1000 Mg (4 ml volume in oily base) will be injected into the upper, outer quadrant of the buttock at 0, 6, 12,16,20, 24 weeks according to manufacturer recommendations |
| Measure | Description | Time Frame |
|---|---|---|
| Increase in Lean Appendicular Muscle Mass by more than 10% in both groups | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement by 10 % in Hand Grip strength in both groups | 24 weeks | |
| Improvement by 10 % in6 minute walk distance in both groups | 24 weeks | |
| Improvement by 10 % in the increased bone and muscle mass in both groups |
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Inclusion Criteria:
Exclusion Criteria:
Males only
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dr Shushrut Singh, MD | Contact | 01146300000 | drsushrut20@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Liver & Biliary Sciences | Recruiting | New Delhi | National Capital Territory of Delhi | 110070 | India |
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| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| Standard Medical Treatment | Drug | Standard Medical Treatment |
|
| Exercise | Other | Exercise |
|
| 24 weeks |
| Improvement by 10 % L3 Skeletal Muscle Index in both groups. | 24 weeks |
| Improvement by 10 % in serum ammonia levels in both groups | 24 weeks |
| Improvement by 10 % in muscle fibres on Biopsy in both groups • | 24 weeks |
| Reduction in Myostatin level in both groups | 24 weeks |
| Improvement in MELD scores in both groups | 24 weeks |
| Decrease in mortality over 6 months in both groups | 24 weeks |
| Changes in HBA1C level in both groups | 24 weeks |
| Reduction in requirement of hospital admissions in both groups | 24 weeks |
| Decrease in TNF alpha levels in both groups | 24 weeks |
| D013568 |
| Pathological Conditions, Signs and Symptoms |