Clinical Review for Liver Restore
The Safety and Efficacy of Liver Restore On Patients Inflicted with Chronic Hepatitis C
Abstract
This multi-center, prospective, randomized, placebo-controlled, double-blind clinical trial on the efficacy and safety and efficacy of Liver Restore has been submitted the Journal of Liver Pathology. The manuscript has passed all revisions and is pending publication. The purpose of the clinical study was to test the efficacy and safety of Liver Restore by assessing the following symptoms and physical findings: nausea, vomiting, diarrhea, loss of appetite, fatigue, abdominal pain, headache, and mental disturbances (confusion, lethargy, lack of concentration, irritability, and sleepiness).
Objectives
Investigators (Khano et al) measured and evaluated laboratory results through a visual analog scale assessment of the following: persistent Jaundice, ascites, integrity of the urine and stool, weight loss, liver enzymes (alanine and aspartate amino transferases), and HCV RNA assays (viral load).
Materials and methods
100 subjects from three centers underwent randomization and were divided into two groups to receive either the active investigational product (Liver Restore) or a placebo with a non-active recipient. The duration of the study was 90 days. Patients were screened to meet the inclusion and exclusion criteria for the study protocol. Thereafter, three follow-up visits were scheduled at week 4, week 8, and week 12 to ascertain subjects' symptoms and physical findings.
Conclusion
At the completion of the clinical trial, Liver Restore showed a significant improvement in reducing all of the following: nausea, vomiting, diarrhea, loss of appetite, fatigue, abdominal pain, headache, and mental disturbances (confusion, lethargy, lack of concentration, irritability, sleepiness). In addition, the participant subjects experienced significantly lower occurrences of jaundice and ascites. Also, weight loss, liver enzymes (alanine and aspartate amino transferases), and HCV RNA assays (viral load) were significantly lower in the group which received the active ingredient when compared with placebo.
Moreover, investigators reported no adverse events from the ingestion of the investigational product.
Study Investigators
Charlie Khano, MD
, Internal Medicine,
Durango Medical Group, Denver, Colorado
Brenda Karkinova,
Internal Medicine,
Kersk State Medical University, Kursk Russia
Jack Haddad, DPM,
Orthopedic Surgery
, Highland Hospital, Oakland, CA
, San Jose Orthopedic Medical Group, San Jose, CA
Cindy Maloore, Ph.D.
, Nutritionist
Private Practice, Santa Clara, CA
Carol Poppay, RN,
Intel Corporation, Santa Clara, CA
The study was submitted to:
Journal of Therapeutics
Journal of Hepatology