Key Findings from the Phase 2 & Phase 3 Clinical Trial on DigestaCure® AUTOIMMUNE-X® Part 2 of 2

In order to demonstrate the effectiveness of  DigestaCure® AUTOIMMUNE-X®, we have proceeded with Phase 2 and Phase 3 Trials, which have shown incredibly encouraging results, prompting Phase 4 Trials to be conducted, obtaining data from patient files of doctors and natural healing practitioners using the formulation in their practices.

We have had over 20 years of success, treating patients with chronic diseases or autoimmune conditions, with immune modulators

Hence, in the Phase 2 trial, our objective was to demonstrate the period of time required for healing, as well as the therapeutic improvement, in patients suffering from diagnosed autoimmune diseases, through the administration of low doses of the formula, thereby confirming its safety and nontoxic properties. 

A. The Method of the Study for Phase 2 Clinical Trials 

1. Method of Data Collection  

  • Most patients start taking DigestaCure® AUTOIMMUNE-X® as they suffer from the long-term symptoms of autoimmune diseases or from the side effects of pharmaceutical medications used to treat them. 

  • The 186 participants chosen for the Phase 2 Clinical trial were males and females, from varying age groups, who exhibited symptoms of autoimmune diseases at differing levels of intensity and progression, over a period of 12 months beginning in March 2015. 

  • Like all patients who opt to take the formula, they were encouraged to take doses prescribed, consistently, communicate with the support team and voluntarily submit standardized electronic Progress Submission Forms, monthly, during their treatment. Each person’s report represented one month of their healing period. 

  • Excluding their personal information, all other data received through these reports was compiled, analyzed, and categorized.

  • Progress Submission Forms rejected were duplicate forms, and forms left incomplete in critical areas such as; number of months taking, dosages being taken, and percentage of improvement experienced.
 

2. Study Structure 

a. Participants protected from knowledge of clinical testing:

Participants purchased the formula on their own and were unaware that their submitted data would be part of a clinical trial, avoiding potential bias in their progress reports.

b. Physicians unaware of Clinical Testing:

Most of the participants’ doctors were unaware that their patients were taking immune modulators and that their data would be part of a clinical trial. Minimal physician encouragement and negative reinforcement to participants would nullify any “placebo effect.

c. Placebo free trial: 

A review of the double-blind study method shows that placebos have created a false sense of security in research. The worsening of patient’s conditions while on placebos during a trial is demoralizing.

To obtain approval of patented drugs, this method is touted by the pharma/medical industries as the “gold standard”. The goal is to demonstrate an improvement in symptom relief, between the placebo and the drug being tested. A 10% margin is considered significant to gain approval, if adverse reactions are at acceptable levels.

However, according to a study from Johns Hopkins University, the drug industry is now the third leading cause of deaths in the US.  Some of these deaths occur during double-blind studies, either due to patients succumbing to their illness while on the placebo or dying from adverse reactions of the drug. 

In our humble opinions, healing the patient without harm should be the gold-standard, and healing incurable diseases should be the Platinum Standard, which involves the administration of an effective and harmless substance, to all the study participants. 

3. Patients included, excluded or discontinued from the study 

  • 50 % of participants, instructed to raise dosages from 8 to 12 capsules per day during the healing process could not do so, due to personal financial restrictions. Half of them showed 20-50% therapeutic improvement at the time they dropped out. This obstacle may be overcome once insurance coverage is obtained.

  • Some participants did not submit updated reports during or after their healing periods. Reductions in symptoms, especially pain, encourages non- compliance as patients discontinue treatment prematurely, without consulting doctors. 


4. Analysis and Interpretation of Results 

Flavianny Santos, CCRC (Certified Clinical Research Coordinator), Andrea Larsen (Medical Research Coordinator/Licensed Nutritionist), the Phase 2 statisticians mentioned that because autoimmune conditions addressed in this study are considered incurable, consistent improvements in any of them, are  profound, and levels of progress, evaluated through the data, are considerable. 

The diagram below, illustrates that the healing process builds up over time, without any adverse reactions. However, the 12-month interval demonstrated is not relevant as with changes in the dosages, time frames can be accelerated to give faster and better results.

 

B. Dosage of the medication and the consequences on therapeutic efficacy 

Method of Ingestion: The formula is available as capsules. The contents can be mixed with water, or they may be swallowed. It may be taken with or without food. 

The Standard Dosage Procedure: starts with 1 capsule on Day 1, increasing by one capsule per day, reaching 8 capsules per day on Day 8. The average therapeutic dose continued, is between 8-12 capsules per day, evaluated periodically for adjustments.

The data indicates that consistent treatment leads to greater therapeutic improvement.  

12 Capsules daily yielded a nearly 15% greater therapeutic improvement across the months of the healing phases, as compared to 8 capsules daily.

No of partients Dosage / Healing phase % Therapeutic Improvement
99 8 capsules per day 35.95% per person
47 12 capsules per day 41.27 % per person
14 8 to 12 months 77.85% per person
7 10-12 months 81.42% per person

 

C. Additional Observations

  • On occasion, a tough case has responded after 8 months of treatment.

  • In non-responsive cases, with higher daily dosages of 18 to 24 capsules (9 to 12 grams) 4 out of 5 show therapeutic improvement within one month.

  • We believe that limited or damaged receptor sites (enterons) within some patients’ small intestinal tracts, may play a role in the amount of formula absorbed.

  • Using higher levels of the immune modulators increases chances of the remaining functioning enterons catching and absorbing a modulator, thereby improving efficacy.

D. Maintenance Doses

Once the patient has recovered, dosage levels required to maintain healthy immune function and to prevent recurring symptoms may vary, but in most cases, are much lower than the standard dosage levels.

E. Dosages to Avoid Herxheimer Reactions (Detoxification or Healing Crisis)

Herxheimer Reactions or “detoxification symptoms” can be a concern for “highly toxic” or “super- sensitive” individuals, lasting from a few minutes to a few hours, without harming tissues or cells.

The formulation for immune modulators is anti-fungal, anti- viral, anti- bacterial, and anti-parasitic. In order to avoid symptoms of rapid “die-off,” of these microorganisms, we eliminate disease-causing pathogens gradually.

The Very Gradual Step-Up Dosage Procedure is done over 4 days to ensure that the body gets acclimatized to the healing process.
Day of Treatment Dosage Medium of Ingestion
Day 1 to Day 4 1/8 capsule Contents shaken in water
Day 5 to Day 8 1/4 capsule Contents shaken in water
Day 9- Day 12 1/2 capsule Contents shaken in water
Day 13 to Day 16 1 capsule Contents shaken in water

What is DigestaCure® AUTOIMMUNE-X®? What is its mechanism of action? 

After years of testing, Pristine Nutraceuticals discovered a combination of extracted, stabilized, and concentrated GRAS, USDA food materials, in precise proportions, which together may nudge the immune system out of the attack-mode of autoimmunity, and back into the state of normalcy, without any known contraindications with other medications. 

This natural formula contains specific phytonutrients (mannans) derived from 20th generation aloe botanicals, which are processed and stabilized (preserved in biologically active form), through a unique proprietary method.   

These include stabilized: 

  • long-chain polymannan and polysaccharide molecules
  • mannose molecules
  • glycoproteins
  • glucomannans, glucopolymannans
  • glycolipids, polysaccharides (oligosaccharides)
  • mucopolysaccharides
 

 Identification of the problem: 

Under a microscope, a fuzzy coating or glycocalyx is seen, surrounding the surface of immune killer cells. This is a coding system (a guidance system) which helps in cell communication. 

It is made up of Immune Modulating Components (IMCs) which function like a “GPS SYSTEM” for immune killer cells so that they may find their target, the pathogen. When an adequate number of IMCs are present in the body, the immune cells are able to accurately locate and eliminate pathogens which promote illness and disease.

However, if the IMC levels are low or absent, the immune cells are unable to distinguish between pathogens and the body’s own cells and attack them instead. This is known as autoimmunity. Attacks in the joints are referred to as arthritis, those in the thyroid known as Hashimoto’s Thyroiditis or Grave’s Disease, and in the digestive tract may be ulcerative colitis or Crohn’s Disease. 

Our Successful Healing Approach: As opposed to treating diseases, we supply the body’s immune system with required immune modulators, so that it can rectify auto-immune diseases on its own. 

Conclusion:

Over the past 20 years I have had the chance to witness the benefits of this formula in treating chronic degenerative or autoimmune diseases. 

The data from Phase 2 and Phase 3 Clinical Trials also reflect the same, showing the potential DigestaCure® AUTOIMMUNE-X® has the ability to change the direction of modern medical treatment away from drug-based methodology to a harmless and effective natural therapeutic approach.

 

“Incurable” Diseases can now be HEALED! Chronic Autoimmune Conditions can now be eliminated by restoring ACCURACY to the IMMUNE SYSTEM, and allowing IMMUNITY to heal the body.

RECENT Posts
NATURAL HEALING – WWW.DRRONDRUCKER.COM

Dr. Ronald P. Drucker teaches natural healing breakthrough: Proper Immune Activation Eliminates 100+ Diseases classified as “incurable” by the drug-based medical community.

Dr. Drucker is a natural healing physician with 21 years of experience in healing Autoimmune Conditions, spreading the word about healing Autoimmune Conditions, and teaching other physicians how to heal autoimmune conditions. “I am able to openly teach any individual or practitioner, and spread the word that these “incurable conditions” are indeed very easily healed, because I am an independent who is not selling drugs or supplements, and who is not being compensated by any party who is. I am referring the individual and practitioner to a healing procedure, and I am charging no fees to do so.”

Dr. Ronald P. Drucker, B.S.M.T. (A.S.C.P.), D.C.
By extracting, stabilizing, and concentrating the active healing ingredients in aloe, DigestaCure® AUTOIMMUNE-X® contains over Sixty Eight (68) times the active healing ingredients compared to any other product, as confirmed via independent size-exclusion chromatography testing. NOTHING Comes Close to The Endless Health Benefits of DigestaCure® AUTOIMMUNE-X®

From the Published Research Studies, and my direct experience, the active ingredients in DigestaCure® AUTOIMMUNE-X®:

  • Are incorporated into the cell membranes throughout the body, enhancing the membranes effectiveness regarding a number of known functions.
  • Create a dramatic overall improvement of the assimilation of nutrients through the digestive tract, AND the intake of nutrients through the cell membranes.
  • Help stop and prevent the damage and leakage of the intestinal wall (leaky-gut syndrome), thereby alleviating the stress from the immune system.
  • Protect the mucous membranes lining the respiratory, gastrointestinal, and genitourinary tracts resulting in an increased resistance to infections, irritations, inflammation, and subsequently tissue lining degeneration.
  • Restore the glycocalyx coatings on the surfaces of killer cells enabling the killer cells to identify disease causing germs and destroy them, instead of blindly attacking the tissues of the body (Anti-Autoimmunity).
  • Provide much of the language (coding) of The Code of Life for cellular recognition, intracellular communication, and communication between cells (intercellular) and the immune system.
  • Possess immune modulating and immune stimulating effects. Stimulate accurate antibody production (by leukocytes) and an increase in the number of accurate killer T-cells produced. This expresses the tremendous importance in these immune stimulating functions. The levels of accurate antibodies present in our blood directly affects our ability to destroy pathogenic (disease causing) organisms. The killer T-cells are among our first line of defense in destroying dangerous bacteria and viruses and may even protect us from those responsible for an array of cancers.
  • Possess anti-inflammatory functions particularly effective in autoimmune diseases, due in part to the specific inhibition of leukotriene B-4, a highly pro-inflammatory substance.
  • Are likely to reduce the incidence of cancer, stroke, and heart disease, along with all autoimmune diseases. This is due primarily to the scientifically established fact that chronic inflammation increases the incidence of these conditions.
  • Contain antioxidant and free radical scavengers. The importance of antioxidants to overall health and longevity is profound. Antioxidants prevent the destruction of DNA by protecting the strands form the free radicals responsible for the destruction of DNA. Research indicates that the amounts and quality of antioxidants we consume are directly proportional to how long we will live and the quality of our lives.
  • Enhance the excretion of toxins from the cells, both intracellular and extracellular, by a unique process known as exocytosis.
  • Possess anti-viral, anti-bacterial, anti-yeast, anti-fungal, anti-mold, and anti-parasitic effects which are of particular interest especially today, linked to the increased incidence of antibiotic resistant strains of pathogens that are no longer responsive to treatment. This further establishes why the ingestion of these active ingredients are so helpful in preventing, normalizing, and correcting so many digestive tract disorders.
  • Possess hypoglycemic and blood sugar normalizing functions in both Type I and Type II diabetics.
  • Contain an insulin-like growth factor that lowers the required amount of insulin needed to maintain normal blood sugar levels.
  • Reduce the amount of insulin needed, thereby reducing cardiovascular risk factors and stress on the pancreas and likely increasing its useful life.
  • Enhance chemotaxis, the migration of immune cells to a site of injury or infection, eliminating infections, and thereby initiating the repair and healing response; promoting tissue growth and regeneration.
  • Support and Protect the Endothelial Glycocalyx, the critical lining protecting the arteries. See Below:

Stem cell therapy doctors are finding that patients taking DigestaCure® AUTOIMMUNE-X® over periods of months, possess up to 1000% (Ten Times) Higher Healthy Stem Cell Counts.

Stem Cells Can Heal and Regenerate

Stem cells are the foundation cells for our bodies. These highly specialized cells that make up our organs and tissues, originally came from an initial pool of stem cells that formed shortly after fertilization. Throughout our lives, we continue to rely on persisting stem cells to repair injured tissues and replace cells that are lost every day, such as those in our skin, hair, blood, muscles, nerves, lining of our gut, brain and all other the organs and glands.

For centuries, men of medicine were under the assumption that when injury, such as a cut through the skin, fat and muscle occurred, that by cleaning and binding the wound together, the muscles and skin would grow into each other, thus healing the wound. By the 1960s, with the help from microscopes and modern technology, man discovered that it was actually stem cells filling the gap of the wound, “differentiating” or transforming themselves into muscle, fat, and skin cells needed to mend the wound.

Dr. Melvin M. Propis, M.D.: “In all my years of performing stem cell therapies, I have never witnessed healthy adult stem cell counts coming close to those patients who had been taking DigestaCure® AUTOIMMUNE-X®. I am now taking the AUTOIMMUNE-X myself, and recommend it to every appropriate patient before and after stem cell therapy. I believe it creates a Total Body Homeostasis, conducive for strong healthy adult stem cell replication.”

Dr. Melvin M. Propis, M.D., of Plantation, Florida is highly regarded as one of the Nations’ Top Stem Cell Therapy Practitioners.
Call Dr. Propis for a consultation Today: 954-587-7600. Office address: 333 N.W. 70th Avenue – Suite 201 – Plantation, FL 33317

How Powerful are They? Can Stem Cells Heal Damage as Severe as Paralyzation?

When Kristopher Boesen of Bakersfield regained consciousness after losing control of his car while driving in wet conditions, he was paralyzed from the neck down. The prognosis was grim: he was told that he might never regain control of his limbs again.

But he has. At least some of them. He has movement in his upper body and can use his arms and hands. He can feed himself, text friends and family and even hug them. To him, this means that he has his life back. How did this miracle come about?

Kris was offered the opportunity to participate in a human clinical trial at the University of Southern California and Asterias Biotherapeutics. He is one of five previously paralyzed patients who experienced increased mobility after being treated with Stem Cells.

Practitioners are discovering that DigestaCure® AUTOIMMUNE-X® aggressively promotes an environment of Total Body Homeostasis. By Andrea Larsen, Licensed Nutritional Consultant
Total Body Homeostasis or Total Physiologic Stability is a bodily status where all Systems, Organs, and Cells are functioning perfectly as designed, without interference from physiologic stress, disease, or premature aging (deterioration). Homeostasis is characteristic of a system that regulates its internal environment and maintains a stable, relatively constant condition of properties. It is a state where all bodily parameters and markers exist within a normal range of values. This is the proverbial “State of Perfect Health.” Total Body Homeostasis is key to life, and failures in homeostasis can lead to hundreds of various diseases, and premature aging. Homeostasis can be defined as an Ease or normalcy of bodily functions and processes. Disease or Dis-Ease can be defined as trouble, – the lack of Ease. In my 35 years of experience, I have continually witnessed that many patients can ingest all of the best foods and quality supplements available, never reach Homeostasis, and still fall victim to disease and premature aging.

Imagine ingesting One Substance, containing the properties which create the very foundation necessary for Total Body Homeostasis, whereupon all other quality substances ingested then may have access to perform their individual benefits. I have found this substance to be DigestaCure® AUTOIMMUNE-X®, and the healings I have accomplished in the last 2 years I have used it with patients, far outweigh all of the former.

A successful innovator, educator, and lecturer in the fields of holistic health and natural healing for over 35 years, Andrea Larsen is highly regarded among the top authorities on nutrition and healing in South Florida. As an integrative practitioner utilizing a complementary approach, her goal is to promote your health and happiness by providing individualized programs to support your total wellness.

Contact Andrea Larsen: Tel: 305-895-5533 email: info@ultimate-nutrition.net

Causeway Square Building, 1801 NE 123rd Street, Suite 314, North Miami, FL 33181

 

Dr. Derrick DeSilva, M.D., and Dr. Jeffrey Gladden, MD, FACC throw new light on the question by looking at the endothelial glycocalyx. That’s the microscopic film covering and protecting the vascular endothelium within the arteries.

“It is the clotting in response to plaque disruption, not the plaque accumulation in the arteries per se that poses the real threat. 75% of heart attacks occur at arteries that are less than 50% blocked…”

“To protect endothelial function, we must support its existing natural protection, the endothelial glycocalyx.”

International Journal of Biological Sciences: “Alterations of endothelial cells and the vasculature play a central role in the pathogenesis of a broad spectrum of the most dreadful of human diseases, as endothelial cells have the key function of participating in the maintenance of patent and functional capillaries. The endothelium is directly involved in peripheral vascular disease, stroke, heart disease, diabetes, insulin resistance, chronic kidney failure, tumor growth, metastasis, venous thrombosis, and severe viral infectious diseases. Dysfunction of the vascular endothelium is thus a hallmark of human diseases.” Int J Biol Sci. 2013; 9(10): 1057–1069.

The endothelial glycocalyx protective linings are made up of and supported by the glycoproteins and other stabilized components found in DigestaCure® AUTOIMMUNE-X®.