| Trial ID: | L0024 |
| Source ID: | NCT01680003
|
| Associated Drug: |
Hepar-P
|
| Title: |
Hepar-P Study to Evaluate the Safety and Efficacy of a Standardised Extract of Phyllanthus Niruri for the Treatment of Non-alcoholic Fatty Liver Disease
|
| Acronym: |
Hepar-P
|
| Status: |
Unknown status
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Non-alcoholic Fatty Liver Disease
|
| Interventions: |
Drug: Hepar-P|Drug: Placebo for Hepar-P
|
| Outcome Measures: |
Improvement in serum aspartate aminotransferase and alanine aminotransferase levels|Histologic findings including degree of steatosis, lobular inflammation, hepatocellular ballooning and fibrosis and overall disease activity score
|
| Sponsor/Collaborators: |
Nova Laboratories Sdn Bhd
|
| Gender: |
All
|
| Age: |
18 Years to 80 Years ?? (Adult, Older Adult)
|
| Phases: |
Phase 2
|
| Enrollment: |
50
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
|
| Start Date: |
September 2012
|
| Completion Date: |
December 2013
|
| Results First Posted: |
--
|
| Last Update Posted: |
April 12, 2013
|
| Locations: |
Sultamah Bahiyah Hospital, Alor Setar, Kedah, Malaysia|Kuala Lumpur Hospital, Wilayah Persekutuan, Kuala Lumpur, Malaysia|Tengku Ampuan Afzan Hospital, Kuantan, Pahang, Malaysia|Queen Elizaberth Hospital, Kota Kinabalu, Sabah, Malaysia|Ampang Hospital, Selangor, Malaysia
|
| URL: |
https://ClinicalTrials.gov/show/NCT01680003
|