Safety and Efficacy of Hoodia Gordonii for Treatment of Non Alcoholic Fatty Liver Disease (NAFLD)
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|ClinicalTrials.gov Identifier: NCT00816465|
Recruitment Status : Completed
First Posted : January 1, 2009
Last Update Posted : September 17, 2010
This clinical study is designed to evaluate the safety of oral administration of the medical food Hoodia to patients with non alcoholic fatty liver disease.
Oral administration of Hoodia is common in many western world countries for appetite suppression and as a food supplement or medical food used for dietary purposes.
Nonalcoholic steatohepatitis or NASH is a common, often "silent" liver disease which affects about 2%-5% of Americans. NASH is strongly associated with the metabolic syndrome, diabetes type-2 and obesity and can lead to cirrhosis, HCC, liver transplantation or death.This clinical trial has been designed to assess the safety of short term oral administration of Hoodia to patients with NASH.
|Condition or disease||Intervention/treatment||Phase|
|Non-Alcoholic Fatty Liver Disease||Dietary Supplement: Hoodia gordonii Other: Placebo||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Study Start Date :||May 2009|
|Primary Completion Date :||June 2010|
|Study Completion Date :||August 2010|
Patients receiving Hoodia
Dietary Supplement: Hoodia gordonii
PO administration of 1 Tab Hoodia gordoni extract per day.
Placebo Comparator: 2
Patients receiving placebo
PO Placebo pill
- decreased insulin resistance [ Time Frame: 30 days ]
- safety [ Time Frame: 60 days ]
- reduced hepatic injury [ Time Frame: 30 days ]
- reduced weight/BMI/abdominal circumference [ Time Frame: 30 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00816465
|Hadassah Medical Center|
|Jerusalem, Israel, 91120|