Enercel: a natural source of cellular energy

Tuberculosis Studies

Dariel Laurent MD, VP Dubrov MD, David Christner MD [MA], PhD

1. A RANDOMIZED, THREE-ARM OPEN-LABEL STUDY OF ENERCEL^®AND ANTI-TUBERCULOSIS DRUGS ALONE OR IN COMBINATION FOR PULMONARY MULTI-DRUG RESISTANT TUBERCULOSIS (MDR-TB)

OVERVIEW:

This is a randomized, three-arm, open-label trial of a homeopathic formulation, Enercel^®, which is to be administered IM, SL, intranasally and via nebulizer alone or in combination with standard antibiotic therapy for patients with Multidrug Resistant Tuberculosis (MDR-TB). Subjects must have evidence of an active pulmonary TB infection defined by: documented fever > 100.5° F; cough; and weight loss > 15 lbs over 3 months. In addition, they must have a Chest X-ray (CXR) and/or chest CT scan with pulmonary infiltrates within the 3 weeks prior to enrollment and a sputum culture positive for Mycobacterium tuberculosis (with sensitivity testing) within 3 months. For the purposes of this study, MDR-TB is defined as complete resistance to isoniazid (INH) and rifampin. The use of standard antimicrobial therapy alone will serve as a control. Standard therapy is defined as four or more anti-tuberculosis drugs as determined by the patient’s medical team based upon sensitivity results. The strain in any given patient must have intermediate or fully sensitive status to each drug used.

The study subjects will be voluntary, adult participants who meet criteria for MDR-TB. Both treatment-naïve and prior treatment status are acceptable, but any new anti-tuberculosis therapy within 3 months of enrollment is not allowed. Study participants will be randomized to receive standard medical treatment alone, Enercel^® alone or a combination of antibiotics with Enercel^®. The study period will be 18 months. There will be a preliminary analysis when 50% of patients complete 6 months. Based upon this data, the study will: 1) be terminated if results are poor 2) extended or 3) subjects will be crossed-over to the most successful regimen if there is a large discrepancy in outcomes among the three groups. It is anticipated that 60 subjects will be enrolled, 20 in each arm.

Study group A will receive standard medical treatment; group B will receive standard medical treatment along with Enercel^® on the following schedule: IM 3cc daily for the duration of the study. Enercel^® Mist Nasal will be given 2 puffs into each nostril three times daily and Mist Nebulizer given via nebulizer twice daily. In addition, Enercel^® Max 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 cancers. 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 controlling MDR-TB infections. Doses up to 50cc IV bid have been used without side-effects or toxicity.

Standard medical treatment will consist of three or more anti-tuberculosis drugs based upon strain sensitivity results, including, but not limited to: ethambutol, streptomycin or other aminoglycoside, pyrazinamide, rifabutin, cycloserine, macrolides, quinolones, thioamides, linezolid, thiorizadine, and 4-aminosalicylic acid (PAS).

2. A RANDOMIZED, THREE-ARM, OPEN-LABEL STUDY OF ENERCEL^® AND ANTI-TUBERCULOSIS DRUGS ALONE OR IN COMBINATION FOR TREATMENT-NAÏVE, DRUG-SENSITIVE, PULMONARY TUBERCULOSIS

OVERVIEW:

This is a randomized, three-arm, open-label trial of a homeopathic formulation, Enercel^®, which is to be administered IM, SL, intranasally and via nebulizer alone or in combination with standard antibiotic therapy for patients with Drug-sensitive Tuberculosis (TB). Subjects must have evidence of an active pulmonary TB infection defined by: documented fever > 100.5° F; cough; and weight loss > 15 lbs over 3 months. In addition, they must have a Chest X-ray (CXR) and/or chest CT scan with pulmonary infiltrates within the 3 weeks prior to enrollment and a sputum culture positive for Mycobacterium tuberculosis (with sensitivity testing) within 3 months. For the purposes of this study, drug-sensitive TB is defined as complete culture-sensitivity to isoniazid (INH) and rifampin. The use of standard antimicrobial therapy alone will serve as a control. Standard therapy is defined as: isoniazid, rifampin, pyrazinamide, and ethambutol for two months, then isoniazid and rifampicin alone for a further four months. Streptomycin may be substituted for ethambutol in patients who cannot tolerate it or have resistance. The strain in any given patient must have intermediate or fully sensitive status to each drug used.

The study subjects will be voluntary, adult participants who meet criteria for drug-sensitive TB. Only treatment-naïve status is acceptable; any prior anti-tuberculosis therapy > 1 month in duration is not allowed. Study participants will be randomized to receive standard medical treatment alone, Enercel^® alone or a combination of antibiotics with Enercel^®. The study period will be 6 months. It is anticipated that 60 subjects will be enrolled, 20 in each arm.

Enercel^® is a homeopathic formulation that has been used safely and successfully in multiple cancers. 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 controlling TB infections. Doses up to 50cc IV bid have been used without side-effects or toxicity.

Standard therapy is defined as: isoniazid, rifampin, pyrazinamide, and ethambutol for two months, then isoniazid and rifampicin alone for a further four months. Streptomycin may be substituted for ethambutol in patients who cannot tolerate it or have resistance.