Hepatitis C Study

Dariel Laurent MD, Sergei Mukomolov MD, David Christner MD [MA], PhD

    A DOUBLE-BLIND, PLACEBO-CONTROLLED, CROSSOVER STUDY OF ENERCEL® FOR BOTH TREATMENT NAÏVE AND PREVIOUSLY TREATED PATIENTS WITH CHRONIC HEPATITIS C INFECTION

    OVERVIEW:

    This is a double-blind, placebo-controlled, crossover trial of a homeopathic formulation, Enercel®, which is to be administered IV, IM and orally in patients with chronic Hepatitis C (HCV) infection that have an initial viral load ≥ 400,000 IU/ml. Eighty subjects will be enrolled into group A or group B– forty into each group. Group A will receive blinded Enercel® for 3 months followed by placebo for 3 months and Group B will receive placebo for 3 months followed by blinded Enercel® for 3 months. Either treatment-naïve or previously treated patients with standard therapy including interferon alone or with ribavirin will be allowed into the trial. Statistical analysis will be applied to determine a primary endpoint of decreased viral load over time, and a secondary endpoint of comparative responses between treatment-naïve and treatment-experienced patients will be evaluated.

The study subjects will be voluntary, adult, participants who meet criteria for chronic HCV infection. Prior treatment with interferon alone or with ribavirin is permissible, but there is a 1 month wash-out period prior to enrollment. Newly-diagnosed and/or treatment naïve patients will also be enrolled. Study participants will each receive a standard Enercel® treatment protocol while on active treatment. The study period will be 6 months.

Enercel® or placebo will be given on the following schedule: 50cc IV daily for 10 days followed by IM 3cc daily for the duration of the study. In addition, Enercel® Max and Forte (or matching placebo) will be given 20 drops SL bid for the entire study. The participants will be monitored monthly or as clinically indicated.

Enercel® is a homeopathic formulation that has been used safely and successfully in multiple chronic viral infections. It appears to act primarily through enhancement of membrane potentials and alternate energy (ACE) pathways. It has been shown to increase Natural Killer (NK) cell function, a process that may be important in limiting persistent viral infections. It has demonstrated antiviral effect in animals. Case reports have demonstrated significant drops in hepatitis C viral load and improvement in clinical status for HCV patients treated with Enercel®. Doses up to 50cc IV bid have been used without side-effects or toxicity.

A history of standard medical treatment consists of interferon alone or in combination with ribavirin.

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