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Safety and Efficacy of Hoodia Gordonii for Treatment of Non Alcoholic Fatty Liver Disease (NAFLD)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00816465
First Posted: January 1, 2009
Last Update Posted: September 17, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Hadassah Medical Organization
December 31, 2008
January 1, 2009
September 17, 2010
May 2009
June 2010   (Final data collection date for primary outcome measure)
  • decreased insulin resistance [ Time Frame: 30 days ]
  • safety [ Time Frame: 60 days ]
Same as current
Complete list of historical versions of study NCT00816465 on ClinicalTrials.gov Archive Site
  • reduced hepatic injury [ Time Frame: 30 days ]
  • reduced weight/BMI/abdominal circumference [ Time Frame: 30 days ]
Same as current
Not Provided
Not Provided
 
Safety and Efficacy of Hoodia Gordonii for Treatment of Non Alcoholic Fatty Liver Disease (NAFLD)
Not Provided

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Non-Alcoholic Fatty Liver Disease
  • Dietary Supplement: Hoodia gordonii
    PO administration of 1 Tab Hoodia gordoni extract per day.
  • Other: Placebo
    PO Placebo pill
  • Experimental: 1
    Patients receiving Hoodia
    Intervention: Dietary Supplement: Hoodia gordonii
  • Placebo Comparator: 2
    Patients receiving placebo
    Intervention: Other: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
August 2010
June 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects who have completed the informed consent process culminating with written informed consent by the subject
  • Men and women age 18 to 65 years inclusive.
  • Patients with biopsy proven NASH with a score of 4 or above.
  • Altered glucose metabolism, including diabetes (non treated, or treated with up to 2 drugs (not including insulin) without any change in medication 2 months prior to enrolment), impaired fasting glucose or impaired glucose tolerance.
  • HBA1C between 5.5 and 14%.

Exclusion Criteria:

Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
 
NCT00816465
HoodiaNAFLD-HMO-CTIL
Yes
Not Provided
Not Provided
Dr. Refael Aharon, Yotvata - Hoodia Growers in the Arava
Hadassah Medical Organization
Not Provided
Not Provided
Hadassah Medical Organization
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP