NATUR-LEAF ®

Sterols and Sterolins - a
Natural Health Supplement

Clinical Studies Summary

By: Peter R. Rothschild, MD Ph.D.
Kenneth J. Frank, MD

From February 5, 2000 to May 5, 2000 twelve clinical studies were conducted at four different clinics on the Natur-Leaf ® product, whose ingredients comprise six different sprouts and the African potato root (with a sterol to sterolin ratio of 6:1) along with eight enzymes in a proprietary ionic and mineral blend. The studies were conducted on the following conditions: Recurrent Migraine Headaches, Hypercholesterolemia, Benign Prostatic Hypertrophy (BPH), Rheumatoid Arthritis, Menopausal Syndrome, and Psoriasis. Each study had a population of 36 subjects, for a total of 432 subjects. Two studies were conducted for each of the six different conditions: one study consisted of a standard dosage of 3 capsules (350 mg/capsule) per day, and one study consisted of mega doses of 9 capsules (350 mg/capsule) per day for each condition.

The subjects included both sexes, when appropriate, (otherwise one sex in the BPH and Menopausal studies) who were suffering from the respective disease/condition and who were shown to be resistant to conventional types of medications. Their ages ranged from 30 to 60 years for those with Recurrent Migraine Headaches, Hypercholesterolemia and Psoriasis, and from 45 to 60 years for those with Rheumatoid Arthritis, Menopausal Syndrome, and BPH. The subjects had not been treated with tranquilizers, antidepressants, steroids and/or chemotherapeutic drugs for at least 3 months prior to the beginning of the study. The subjects had not received any prescription medicines for at least 3 months.

Excluded from the studies were individuals declared in critical condition by a licensed health practitioner, individuals afflicted with any acute infectious disease or diabetes, cardio-vascular, renal or immediate life-threatening pathologies. Also excluded were subjects with allergies to any of the components of the Natur-Leaf ® formula, alcoholics and/or drug addicts, convalescents of any trauma more recent than 3 months, and individuals receiving life-supporting prescription medications which affect the immune and/or nervous system.

All participants underwent physical and laboratory examinations prior to the beginning of the studies. The studies were carried out under a standard ambulatory, open-label regime. Treatments began within 30 days after the completion of the above tests and examination. During the entire course of the studies, the participants abstained from consuming both prescription and OTC drugs.

The study targets were aimed at determining the palliative or attenuating effects of the Natur-Leaf ® product in humans of both sexes as indicated above. The studies were carried out under the direction of a duly licensed Doctor of Medicine or of Naturopathic Medicine, assisted by qualified paramedical associates and registered laboratory technicians. Considering that all participating patients were shown to be resistant to conventional types of medication, the studies were carried out under a standard, monotherapeutic, and open-label regime.

All determinations were performed according to standard guidelines set by the World Health Organization (WHO) for standard, ambulatory, non-invasive clinical examination methods. CBC and SMAC-24 laboratory determinations were carried out before and after the trials.

NATUR-LEAF" CLINICAL STUDIES GRAPHIC PRESENTATION

Disease Response Summary Table
Click Image to Enlarge

A= Full Remission
B= Partial Remission (Refers to 60% or better improvement)
C= Moderate Palliation (Implies 40% improvement)
D= Unchanged Condition
E= Worsened Condition
SD=. Standard Dosage (three 350 mg capsules/day)
**MD= Mega Dosage (nine 350 mg capsules/day)

Mega Dosage:

11 patients reported transient symptoms of moderate dizziness and nausea during the first 10 days of the treatment for Benign Prostatic Hypertrophy.

17 patients reported transient episodes of dizziness in varying and moderate nausea grades during the first 12 days of the treatment for Menopausal Syndrome.

15 patients reported transient symptoms of moderate dizziness and nausea during the first 10 days of the treatment for Recurrent Migraine Headaches.

18 patients (13 females and 5 males) reported transient symptoms of moderate dizziness during the first 12 days of the treatment for Hypercholesterolemia.

9 of the female patients reported nausea episodes during that same period.

15 patients reported recurrent transient dizziness and nausea episodes during the first 13 days of the treatment for Psoriasis Syndrome.

11 patients reported transient symptoms of moderate dizziness and nausea during the first 11 days of the treatment for Rheumatoid Arthritis.

In all instances of side effects for the conditions listed above, the symptoms were not recurrent after the initial period mentioned for each condition.

Review of Study Results

Subjects who had previously been treated with standard medical care for Benign Prostatic Hypertrophy, Menopausal Syndrome, Recurrent Migraine Headaches, Hypercholesterolemia, Psoriasis Syndrome, and Rheumatoid Arthritis and who were treated solely with Natur-Leaf ® for 3 months showed improvement ranging from moderate palliation (40% improvement) to complete remission in all cases, except for some conditions. Subjects showing no change were found in the BPH (SD) group (1 subject), the Psoriasis (SD) group (2 subjects), the Rheumatoid Arthritis (SD) group (9 subjects) and Rheumatoid Arthritis (MD) group (1 subject). For each disease studied, the use of a mega dose (nine 350 mg capsules daily) of Natur-Leaf ® showed significantly greater improvement than the use of the standard dosage (three 350 mg capsules daily). The standard dose group showed the greatest improvement for those who had Menopausal Syndrome (14 with complete remission). The mega dose group showed the greatest improvement for those with Recurrent Migraine Headaches (21 with complete remission).

Conclusion

Natur-Leaf ®, a product consisting of a collection of six different sprouts and the African potato root, and which contains a sterol to sterolin ratio of 6:1, demonstrated better treatment benefits for six disease processes than standard medical therapy. Many (8%- 58%) of those treated showed complete remission. The disease processes studied include a broad range of diseases and include several auto-immune diseases. Considering the nature of the diseases and the fact that standard medical treatment of auto-immune diseases consists of medications with considerable untoward side effects, the use of Natur-Leaf ® for these and other diseases deserves further in-depth investigation.